S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT00085501 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000370806S0342U10CA032102
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 163

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with a monoclonal antibody may kill more tumor cells. It is not yet known whether cetuximab is more effective when given at the same time as chemotherapy or following chemotherapy. PURPOSE: This randomized phase II trial is studying how well giving cetuximab at the same time as combination chemotherapy works compared to giving cetuximab after combination chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; squamous cell lung cancer; large cell lung cancer

Outcome Measures

Primary Outcomes (3)

• Select a regimen based on overall survival

  To select a regimen based on overall survival via a Phase II selection design of chemotherapy in conjunction with cetuximab (concurrent vs. sequential) for Phase III testing against chemotherapy alone in Stage IIIB and Stage IV non-small cell lung cancer.

  From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

• Response rate (confirmed and unconfirmed, complete and partial response)

  To evaluate response rates (confirmed and unconfirmed, complete and partial) of patients with selected Stage IIIB and Stage IV NSCLC treated with paclitaxel and carboplatin with concurrent cetuximab or paclitaxel and carboplatin followed by cetuximab.

  From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

• Toxicities

  To evaluate the toxicities of the two treatment regimens in patients with selected Stage IIIB and Stage IV NSCLC.

  From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary Outcomes (2)

• Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response

  At prestudy

• Evaluate EGFR polymorphisms

  At prestudy and week 5

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: cetuximab; Drug: carboplatin; Drug: paclitaxel

2

ACTIVE COMPARATOR

Drug: cetuximab; Drug: carboplatin; Drug: paclitaxel

Interventions

cetuximab DRUG

Arm 1: 400 mg/m2 (Initial dose), 2 hour IV infusion on Day 1, Week 1 only. 250 mg/m2 (Subsequent doses), 1 hour IV infusion, on Day 1 weekly starting at Week 2. Arm 2: 400 mg/m2 (Initial dose), 2 hour IV infusion on Week 13 ONLY 250 mg/m2 (Subsequent doses), 1 hour IV infusion, weekly starting at Week 14.

1; 2

carboplatin DRUG

Arm 1: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 2 Arm 2: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 1

1; 2

paclitaxel DRUG

Arm 1: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 4. Arm 2: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 1.

1; 2

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of one of the following stages: * Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural effusion, any N, M0) * Newly diagnosed stage IV disease (any T, any N, M1) * Recurrent stage IV disease after prior surgery or radiotherapy * The following subtypes are eligible: * Adenocarcinoma * Squamous cell carcinoma * Large cell carcinoma * Unspecified * Measurable disease by CT scan, MRI, x-ray, or physical exam * Pleural effusions, ascites, or laboratory parameters are not acceptable as the only evidence of disease * Not within prior radiotherapy field unless a new lesion is present * Not within area of prior surgical resection * No known brain metastases by CT scan or MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 mg/dL Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * SGOT or SGPT ≤ 2 times ULN * Alkaline phosphatase ≤ 2 times ULN * No known acute hepatitis Renal * Creatinine ≤ ULN * Creatinine clearance ≥ 50 mL/min Cardiovascular * No significant cardiac disease * No uncontrolled hypertension * No unstable angina * No congestive heart failure Other * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission * No active or uncontrolled infection * No sensory neuropathy ≥ grade 2 * No known human anti-mouse antibodies * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy for NSCLC * No prior chimeric or murine monoclonal antibody therapy * No prior cetuximab Chemotherapy * No prior systemic chemotherapy for NSCLC Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered Surgery * See Disease Characteristics * At least 2 weeks since prior thoracic or major surgery and recovered Other * No prior gefitinib or other investigational agents that target the epidermal growth factor receptor pathway

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (163)

Alaska Regional Hospital

Anchorage, Alaska, 99508, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94705, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, 94904, United States

Location

Sutter Health Western Division Cancer Research Group

Greenbrae, California, 94904, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

Valley Memorial Hospital

Livermore, California, 94550, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Summit Medical Center

Oakland, California, 94609, United States

Location

Comprehensive Cancer Center at Desert Regional Medical Center

Palm Springs, California, 92262, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

Sutter Cancer Center

Sacramento, California, 95816, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

California Pacific Medical Center - California Campus

San Francisco, California, 94118, United States

Location

J.C. Robinson, M.D. Regional Cancer Center

San Pablo, California, 94806, United States

Location

CCOP - Santa Rosa Memorial Hospital

Sana Rosa, California, 95405, United States

Location

St. Anthony Central Hospital

Denver, Colorado, 80204, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80217-3364, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, 81401, United States

Location

St. Anthony North Hospital

Westminster, Colorado, 80030, United States

Location

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, 80033, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342, United States

Location

Northside Hospital Cancer Center

Atlanta, Georgia, 30342, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Augusta Oncology Associates

Augusta, Georgia, 30901, United States

Location

WellStar Cobb Hospital

Austell, Georgia, 30106, United States

Location

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States

Location

Southern Regional Medical Center

Riverdale, Georgia, 30274, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403, United States

Location

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, 31603, United States

Location

Cancer Research Center of Hawaii

Honolula, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Lusitana

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Institute at Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital, Incorporated

Honolulu, Hawaii, 96813, United States

Location

OnCare Hawaii, Incorporated - Kuakini

Honolulu, Hawaii, 96817, United States

Location

St. Francis Medical Center

Honolulu, Hawaii, 96817, United States

Location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

Location

Kapiolani Medical Center at Pali Momi

‘Aiea, Hawaii, 96701, United States

Location

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, 62002, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Hematology Oncology Consultants Ltd.

Naperville, Illinois, 60540, United States

Location

Edward Hospital Cancer Center

Naperville, Illinois, 60566, United States

Location

St. Francis Hospital and Health Centers

Beech Grove, Indiana, 46107, United States

Location

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Genesis Medical Center - West Campus

Davenport, Iowa, 52804, United States

Location

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Tulane Cancer Center

New Orleans, Louisiana, 70112, United States

Location

Cancer Treatment Center at Christus Schumpert St. Mary Place

Shreveport, Louisiana, 71101, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48100, United States

Location

St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

Ann Arbor, Michigan, 48106-0995, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Cancer Care Center at Battle Creek Health System

Battle Creek, Michigan, 49017, United States

Location

Bay Regional Medical Center

Bay City, Michigan, 48708, United States

Location

Mecosta County General Hospital

Big Rapids, Michigan, 49307, United States

Location

Josephine Ford Cancer Center at Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48532, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Mercy Medical Center

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Cancer Care - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metropolitan Hospital

Grand Rapids, Michigan, 49506, United States

Location

Spectrum Health Hospital - Blodgett Campus

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Mount Clemens General Hospital

Mount Clemens, Michigan, 48043, United States

Location

Hackley Hospital

Muskegon, Michigan, 49443, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

St. Joseph Mercy Hospital

Pontiac, Michigan, 48341-2985, United States

Location

Seton Cancer Institute - Saginaw

Saginaw, Michigan, 48601, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48903, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Keesler Medical Center - Keesler Air Force Base

Kessler Air Force Base, Mississippi, 39534-2519, United States

Location

St. Francis Medical Center

Cape Girardeau, Missouri, 63701, United States

Location

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

Gape Girardeau, Missouri, 63701, United States

Location

Freeman Cancer Institute at Freeman Health System

Joplin, Missouri, 64804, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, 63141, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute

Great Falls, Montana, 59405, United States

Location

Valley Hospital - Ridgewood

Ridgewood, New Jersey, 07450, United States

Location

Adirondack Cancer Care

Glens Falls, New York, 12801, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Tri-Health Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Community Oncology Group - Independence

Independence, Ohio, 44131, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

MedCentral - Mansfield Hospital

Mansfield, Ohio, 44903, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

United States Air Force Medical Center Wright-Patterson

Wright-Patterson AFB, Ohio, 45433-5529, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

St. Charles Medical Center

Bend, Oregon, 97701, United States

Location

Legacy Mount Hood Medical Center

Glesham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Institute of Oncology at Vilnius University

Portland, Oregon, 97227, United States

Location

Salem Hospital Regional Cancer Center

Salem, Oregon, 97309, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

Rose Ramer Cancer Clinic at Anderson Area Medical Center

Anderson, South Carolina, 29621, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

McLeod Regional Medical Center

Florence, South Carolina, 29506, United States

Location

Bon Secours St. Francis Health System

Greenville, South Carolina, 29601, United States

Location

Greenville Hospital System Cancer Center

Greenville, South Carolina, 29605, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29304, United States

Location

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916, United States

Location

Arlington Cancer Center - Arlington

Arlington, Texas, 76012, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

UMC Southwest Cancer and Research Center

Lubbock, Texas, 79415, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

Memorial Hospital of Martinsville and Henry County

Martinsville, Virginia, 24115, United States

Location

St. Joseph Hospital Community Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Cancer Care Center at Skagit Valley Hospital

Mount Vernon, Washington, 98273, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Group Health Central Hospital

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98114, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Providence Cancer Center at Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Providence Cancer Center at Holy Family Hospital

Spokane, Washington, 99207, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98668, United States

Location

Central Washington Hospital

Wenatchee, Washington, 98801, United States

Location

Wenatchee Valley Clinic

Wenatchee, Washington, 98801, United States

Location

North Star Lodge Cancer Center

Yakima, Washington, 98902, United States

Location

Washington Hematology - Oncology Specialists

Yakima, Washington, 98902, United States

Location

Related Publications (5)

• Franklin WA, Gandara DR, Kim ES, et al.: SWOG S0342 and S0536: expression of EGFR protein and markers of epithelial-mesenchymal transformation (EMT) in cetuximab/chemotherapy-treated non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-11076, 2009.

  BACKGROUND

• Mack PC, Holland WS, Redman M, et al.: KRAS mutation analysis in cetuximab-treated advanced stage non-small cell lung cancer (NSCLC): SWOG experience with S0342 and S0536. [Abstract] J Clin Oncol 27 (Suppl15): A-8022, 2009.

  BACKGROUND

• Hirsch FR, Herbst RS, Olsen C, Chansky K, Crowley J, Kelly K, Franklin WA, Bunn PA Jr, Varella-Garcia M, Gandara DR. Increased EGFR gene copy number detected by fluorescent in situ hybridization predicts outcome in non-small-cell lung cancer patients treated with cetuximab and chemotherapy. J Clin Oncol. 2008 Jul 10;26(20):3351-7. doi: 10.1200/JCO.2007.14.0111.

  PMID: 18612151 RESULT

• Herbst RS, Chansky K, Kelly K, et al.: A phase II randomized selection trial evaluating concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in patients with advanced non-small cell lung cancer (NSCLC): final report of SWOG 0342. [Abstract] J Clin Oncol 25 (Suppl 18): A-7545, 395s, 2007.

  RESULT

• Kelly K, Herbst RS, Crowley JJ, et al.: Concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer (NSCLC): a randomized phase II selectional trial SWOG 0342. [Abstract] J Clin Oncol 24 (Suppl 18): A-7015, 367s, 2006.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung

Interventions

Cetuximab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Roy S. Herbst, MD, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Karen Kelly, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• David R. Gandara, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: July 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: July 1, 2011
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

US (163)