ASA404 or Placebo in Combination With Paclitaxel and Carboplatin as First-Line Treatment for Stage IIIb/IV Non-Small Cell Lung Cancer

NCT00662597 | Terminated Phase 3

• 1 other identifier: CASA404A2301
• Study Type: interventional
• Target: 1,285
• Locations: 26 countries
• Sites: 248

Brief Summary

The purpose of this study is to determine if adding ASA404 to standard chemotherapy makes the cancer treatment more effective in patients with advanced lung cancer.

Conditions

Non-Small Cell Lung Cancer

Keywords

Tumor vascular disrupting agent; VDA; ASA404; non-small cell lung cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• Overall survival rate

  Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date.

Secondary Outcomes (1)

• Overall survival of patients with squamous and non-squamous NSCLC

  Patients will be followed every six weeks for survival following treatment completion, discontinuation, or documented disease progression until either death or the data cut off date.

Study Arms (2)

ASA404

EXPERIMENTAL

Drug: ASA404; Drug: carboplatin; Drug: Paclitaxel

ASA40 Placebo

PLACEBO COMPARATOR

Drug: Placebo; Drug: carboplatin; Drug: Paclitaxel

Interventions

ASA404 DRUG

ASA404

Placebo DRUG

ASA40 Placebo

carboplatin DRUG

ASA40 Placebo; ASA404

Paclitaxel DRUG

ASA40 Placebo; ASA404

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed non-small cell carcinoma of the lung. (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion. Sputum cytology is not acceptable.)
• Newly diagnosed Stage IIIb disease (malignant pleural effusion or pericardial effusion that have been confirmed cytologically) or Stage IV disease
• No prior systemic antineoplastic treatment for Stage IIIb/IV non-small cell carcinoma of the lung (Prior neoadjuvant or adjuvant chemotherapy for earlier stage I/II NSCLC is allowed if 12 months or more prior to Baseline visit.)
• Age ≥ 18 years old
• WHO Performance Status of 0-1
• Measurable or non-measurable disease per RECIST criteria (Post-text supplement 1)
• Lab values within the range, as defined below, within 2 weeks of randomization:
• Absolute neutrophils count (ANC) \> 2.0 x 109/L
• Platelets ≥ 100 x109/L
• Hemoglobin ≥ 10 g/dL
• Serum creatinine ≤ 1.5 x ULN (≤ 120 micro mol/L)
• Serum bilirubin ≤ 1.5 x ULN (≤ 25 micro mol/L)
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases)
• International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 x IULN (Sections 6.9.1 and 7.3.4.2)
• Electrolyte values (potassium, calcium, magnesium) within \> 1 x LLN and \< 1 x ULN. Patients with corrected electrolyte values are eligible. See Sections 6.8.1 and 7.3.4.3.

You may not qualify if:

• Patients having CNS metastases (Patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed.).
• Patients with a history of another primary malignancy ≤ 5 years, with the exception of non-melanoma skin cancer or cervical cancer in situ.
• Radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered from all radiotherapy-related toxicities.
• Concurrent use of other investigational agents and patients who have received investigational agents ≤ 4 weeks prior to randomization
• Prior exposure to Tumor-VDAs or other vascular targeting agents (anti-VEGF, anti-VEGF receptor agents, anti-EGFR agents \[bevacizumab, cetuximab, etc.\])
• Pleural effusion that causes ≥ CTC grade 2 dyspnea
• Patients with systolic BP \> 160 mm Hg and/or diastolic BP \>90 mm Hg
• Patients with recent hemoptysis associated with NSCLC (\> 1 teaspoon in a single episode within 4 weeks)
• Patients with any one of the following:
• Patients with long QT syndrome
• Patients with a Baseline 12-lead ECG QTc of \> 450 msec per central evaluation
• Congestive heart failure (NY Heart Association class III or IV)
• Patients with a myocardial infarction within 12 months of study entry
• Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
• History of labile hypertension or poor compliance with anti-hypertensive regimen

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (248)

University of South Alabama/Mitchell Cancer Institute

Mobile, Alabama, 36604, United States

Location

Arizona Oncology Associates

Tucson, Arizona, 85704, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, 85724-5024, United States

Location

Highlands Oncology Group

Bentonville, Arkansas, 72712, United States

Location

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Alta Bates Summit Medical Center

Berkeley, California, 94704, United States

Location

Pacific Oncology and Hematology Association

Encinitas, California, 92024, United States

Location

Cancer Care Associates

Fresno, California, 93720, United States

Location

Ronald Yanagihara - Private Practice

Gilroy, California, 95020, United States

Location

California Cancer Care

Greenbrae, California, 94904, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093-0698, United States

Location

Loma Linda University Cancer Center

Loma Linda, California, 92354-3834, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California Irvine Comprhensive Center

Orange, California, 92868, United States

Location

Loma Linda Oncology Medical Group, Inc.

Redlands, California, 92374, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

California Pacific Medical Research Institute

San Francisco, California, 94115, United States

Location

Redwood Regional Cancer Center

Santa Rosa, California, 95403, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Palm Beach Institute of Hematology & Oncology

Boynton Beach, Florida, 33435, United States

Location

Florida Cancer Specialists

Bradenton, Florida, 34209, United States

Location

Cancer Centers of Central Florida, PA

Leesburg, Florida, 34788, United States

Location

Advanced Medical Specialties (ACORN)

Miami, Florida, 33176, United States

Location

Northwest Georgia Oncology Centers

Marietta, Georgia, 30060, United States

Location

Cancer Research Center of Hawaii

Honolulu, Hawaii, 96813, United States

Location

Kootenai Cancer Center (ACORN)

Coeur d'Alene, Idaho, 83814, United States

Location

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States

Location

Illinois Oncology/Warren Billhartz Cancer Ctr.

Maryville, Illinois, 62062, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Hematology/Oncology of North Shore

Skokie, Illinois, 60076, United States

Location

Loyola Cancer Care & Research Ctr. at Central Dupage Hospital

Winfield, Illinois, 60190, United States

Location

Ft. Wayne Oncology and Hematology

Fort Wayne, Indiana, 46815, United States

Location

Siouxland Hematology-Oncology Assoc., LLC

Sioux City, Iowa, 51101, United States

Location

Kansas City Cancer Center, Southwest

Overland Park, Kansas, 66210, United States

Location

University of Louisville - James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Hematology Oncology Specialists

Metairie, Louisiana, 70006, United States

Location

Louisiana State University Health Sciences Center - Feist-Weiller Cancer Center

Shreveport, Louisiana, 71103, United States

Location

St. Agnes Cancer Center

Baltimore, Maryland, 21129-5299, United States

Location

Sinai Hospital of Baltimore - The Alvin & Lois Lapidus Cancer Institute

Baltimore, Maryland, 21215-5271, United States

Location

The Harry and Jeanette Weinberg Cancer Institute at Franklin Square/MedStar Health

Baltimore, Maryland, 21237, United States

Location

Peninsula Regional Oncology and Hematology

Salisbury, Maryland, 21801, United States

Location

Boston VA Healthcare System

Boston, Massachusetts, 02130, United States

Location

Fallon Clinic

Worcester, Massachusetts, 01605, United States

Location

Breslin Cancer Center

Lansing, Michigan, 48910, United States

Location

Osteopathic Medical Oncology and Hematology PC

Woodhaven, Michigan, 28183, United States

Location

St. Luke's Hospital - St Luke's Cancer Center

Duluth, Minnesota, 55811, United States

Location

Kansas City Veterans Affair Medical Center

Kansas City, Missouri, 64128, United States

Location

St. Louis University Cancer Center

St Louis, Missouri, 63110, United States

Location

Center for Cancer Care and Research (US Oncology)

St Louis, Missouri, 63141, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

St. Louis Cancer and Breast Institute

St Louis, Missouri, 63141, United States

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Billings Clinic

Billings, Montana, 59107-7000, United States

Location

Sletten Cancer Institute

Great Falls, Montana, 59405, United States

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University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Arena Oncology Associates

Lake Success, New York, 11042, United States

Location

New York Oncology Hematology

Latham, New York, 12210, United States

Location

Hematology Oncology Associates of Rockland

Nyack, New York, 10960, United States

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Rochester General Hospital - Lipson Cancer Center

Rochester, New York, 14621, United States

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Syracuse VA Medical Center

Syracuse, New York, 13210, United States

Location

Eastchester Center for Cancer Care

The Bronx, New York, 10469, United States

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Alamance Regional Medical Center-Cancer Ctr.

Burlington, North Carolina, 27215, United States

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Carolina Cancer Mgmt/Cape Fear Valley Health System/Med Onc

Fayetteville, North Carolina, 28304, United States

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Akron City Hospital

Akron, Ohio, 44309-2090, United States

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Oncology Hematology Care Research

Cincinnati, Ohio, 45242, United States

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University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

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Medical Oncology Hematology Associates, Inc. - Dayton Clinical Oncology Program

Dayton, Ohio, 45429, United States

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Medical Oncology Hematology Associates, Inc.

Dayton, Ohio, 45429, United States

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Cleo Craig Memorial Cancer Ctr. & Research Clinic

Lawton, Oklahoma, 73505, United States

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University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

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Kaiser Permanente, Northwest Region

Portland, Oregon, 97227, United States

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Allegheny General Hospital/Allegheny Cancer Center

Pittsburgh, Pennsylvania, 15212, United States

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South Carolina Oncology Associate

Columbia, South Carolina, 29210, United States

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Lowcountry Hematology & Oncology PA

Mt. Pleasant, South Carolina, 29464, United States

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Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37804, United States

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The West Clinic

Memphis, Tennessee, 38120, United States

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Tennessee Oncology

Nashville, Tennessee, 37203, United States

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Texas Oncology Cancer Center of the High Plains

Amarillo, Texas, 79106, United States

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Arlington Cancer Center

Arlington, Texas, 76012, United States

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Patient's Comprehensive Cancer Center

Carrollton, Texas, 75010, United States

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South Texas Cancer Institute

Corpus Christi, Texas, 78405, United States

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Cancer Care Centers of South Texas

Dallas, Texas, 75204, United States

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Texas Oncology at Presbyterian Hospital

Dallas, Texas, 75231, United States

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University of Texas Southwestern Medical Center/Simmons Comprehensive Cancer Center

Dallas, Texas, 75390-9179, United States

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Texas Oncology at Garland

Garland, Texas, 75042, United States

Location

HOPE Oncology

Richardson, Texas, 75080, United States

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Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

UT Health Center

Tyler, Texas, 75709, United States

Location

Deke Slayton Cancer Center

Webster, Texas, 77598, United States

Location

Texoma Cancer Center

Wichita Falls, Texas, 76310, United States

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Northern Utah Associates

Ogden, Utah, 84403, United States

Location

Danville Hematology & Oncology

Danville, Virginia, 24541, United States

Location

Medical Oncology & Hematology Associates of Northern Virginia

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23230, United States

Location

Highline Medical Oncology

Burien, Washington, 98166, United States

Location

Providence Everett Medical Center/Providence regional Cancer Partnership

Everett, Washington, 98201, United States

Location

Northwest Cancer Specialists

Vancouver, Washington, 98684, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Medical Consultants

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin/Division of Neoplastic & Related Disorders

Milwaukee, Wisconsin, 53226, United States

Location

Novartis Investigative Site

Buenos Aires, Argentina

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Novartis Investigative Site

Capital Federal, Argentina

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Novartis Investigative Site

Córdoba, Argentina

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La Plata, Argentina

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Novartis Investigative Site

Mendoza, Argentina

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Rosario, Argentina

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Heidelberg, Australia

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Herston, Australia

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South Brisbane, Australia

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Duffel, Belgium

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Jette, Belgium

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Liège, Belgium

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Barretos, Brazil

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Belo Horizonte, Brazil

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Goiânia, Brazil

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Jaù, Brazil

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Jaú, Brazil

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Porto Alegre, Brazil

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Santo André, Brazil

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São Paulo, Brazil

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Calgary, Canada

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Greenfield Park, Canada

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Kitchener, Canada

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London, Canada

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Moncton, Canada

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Montreal, Canada

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Rimouski, Canada

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Sainte-Foy, Canada

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Sherbrooke, Canada

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Sult Ste-Marie, Canada

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Beijing, China

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Guangzhou, China

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Shanghai, China

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Wuhan, China

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Xi'an, China

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Brno, Czechia

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Ostrava Poruba, Czechia

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Prague, Czechia

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Bobigny, France

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Boujan-sur-Libron, France

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Clamart, France

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Le Mans, France

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Limoges, France

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Lyon, France

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Marseille, France

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Nice, France

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Paris, France

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Saint-Herblain, France

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Toulon Armées, France

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Tours, France

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Aschaffenburg, Germany

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Bad Berka, Germany

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Berlin, Germany

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Cologne, Germany

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Donaustauf, Germany

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Ebensberg, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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Gerlingen, Germany

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Göttingen, Germany

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Grosshandsdorf, Germany

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Heidenheim, Germany

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Leipzig, Germany

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Merseburg, Germany

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München, Germany

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Nuremberg, Germany

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Athens, Greece

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Heraklion Crete, Greece

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Thessaloniki, Greece

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Hong Kong, Hong Kong

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Budapest, Hungary

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Deszk, Hungary

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Mátraháza, Hungary

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Kfar Saba, Israel

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Rehovot, Israel

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Tel Aviv, Israel

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Tel Litwinsky, Israel

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Zrifin, Israel

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Avellino, Italy

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Milan, Italy

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Modena, Italy

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Napoli, Italy

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Orbassano, Italy

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Parma, Italy

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Perugia, Italy

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Roma, Italy

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Akashi, Japan

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Fukuoka, Japan

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Habikino, Japan

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Hiroshima, Japan

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Kashiwa, Japan

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Kobe, Japan

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Kōtō City, Japan

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Kumamoto, Japan

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Kurashiki, Japan

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Matsuyama, Japan

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Nagoya, Japan

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Niigata, Japan

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Okayama, Japan

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Osaka, Japan

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Ōsaka-sayama, Japan

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Sapporo, Japan

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Sendai, Japan

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Ube, Japan

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Yokohama, Japan

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's-Hertogenbosch, Netherlands

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Amsterdam, Netherlands

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Breda, Netherlands

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Eindhoven, Netherlands

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Harderwijk, Netherlands

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Zwolle, Netherlands

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Auckland, New Zealand

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Christchurch, New Zealand

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Hamilton, New Zealand

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Wellington, New Zealand

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Lodz, Poland

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Lublin, Poland

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Otwock, Poland

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Poznan, Poland

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Singapore, Singapore

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Seoul, South Korea

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Seungnam, South Korea

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Suwon, South Korea

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Barakaldo, Spain

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Barcelona, Spain

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Córdoba, Spain

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Granada, Spain

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Jaén, Spain

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Madrid, Spain

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Pontevedra, Spain

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Seville, Spain

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Zaragoza, Spain

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Umeå, Sweden

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Kaoshiung, Taiwan

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Lin-Ko, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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Altunizade, Turkey (Türkiye)

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Ankara, Turkey (Türkiye)

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Istanbul, Turkey (Türkiye)

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Izmir, Turkey (Türkiye)

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Aberdeen, United Kingdom

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Cambridge, United Kingdom

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Leicester, United Kingdom

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London, United Kingdom

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Manchester, United Kingdom

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Sutton, United Kingdom

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Related Links

• Results for CASA404A2301 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

vadimezan; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 24, 2020

Record last verified: 2012-05

Locations

JP (19); NL (6); ES (9); US (100); BR (8); DE (16); GR (3); HK (1); IT (8); NZ (4); TU (4); AU (3); AR (6); BE (3); HU (3); IL (5); CN (5); PL (4); CZ (3); SG (1); KR (3); CA (10); SE (1); FR (12); TW (5); GB (6)