S0429: Docetaxel, Cetuximab, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

NCT00288054 | Terminated Phase 1 Results DMC

• 3 other identifiers: CDR0000456381U10CA032102S0429
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 77

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving docetaxel and cetuximab together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with cetuximab and radiation therapy in treating patients with stage III non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Treatment-related Esophagitis or Pneumonitis

  The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.

  Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.

Secondary Outcomes (4)

• Toxicity

  Weekly for the first 8 weeks, then every 4 weeks while subject on protocol treatment.

• Overall Survival

  weekly while patient is on protocol treatment, then monthly thereafter.

• Progression-free Survival.

  At week 10, week 22, and then every 3 months until progression for up to 3 years after enrollment.

• Response Rate

  Week 10 and week 22

Study Arms (2)

Cetuximab + Radiotherapy (no Docetaxel)

EXPERIMENTAL

Biological: cetuximab; Radiation: radiation therapy

Cetuximab + Radiotherapy + Docetaxel

EXPERIMENTAL

Biological: cetuximab; Drug: docetaxel; Radiation: radiation therapy

Interventions

cetuximab BIOLOGICAL

Cohorts 1 and 2: 400 mg/m2 (initial dose) 2 hour IV infusion on Day 1, Cycle 1 only. 250 mg/m2, 1 hour IV infusion on Days 8 , 15 and 22 during Cycle 1. 250 mg/m2 (subsequent doses), 1 hour IV infusion on Days 1, 8 , 15 and 22 during subsequent cycles.

Cetuximab + Radiotherapy (no Docetaxel); Cetuximab + Radiotherapy + Docetaxel

docetaxel DRUG

Cohort 2 ONLY: 20 mg/m2 IV over 15 - 30 minutes on Days 8, 15 and 22 of Cycle 1. Concurrent with RT and cetuximab starting at Week 2. 20 mg/m2 IV over 15 - 30 minutes on Days 1, 8, 15 and 22 of Cycle 2.

Cetuximab + Radiotherapy + Docetaxel

radiation therapy RADIATION

Radiation therapy should begin on Day 8 of Cycle 1 and continue through the end of Cycle 2. Refer to Section 12.1 for Radiation Therapy Review. RT prescription should be PTV (GTV + 2-cm margins on CT scan) to 6,480 cGy in 36 fractions given 5 days a week, 180 cGy per day. The dose is prescribed to the isocenter. The entire treatment should be planned prior to starting treatment to ensure that the plan meets protocol specifications.

Cetuximab + Radiotherapy (no Docetaxel); Cetuximab + Radiotherapy + Docetaxel

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically proven newly diagnosed single, primary, bronchogenic stage IIIA or selected stage IIIB (excluding malignant pleural effusion) non-small cell lung cancer (NSCLC) of one of the following cellular types: * Adenocarcinoma * Large cell carcinoma * Squamous cell carcinoma * Unspecified * Histology or cytology from involved mediastinal or supraclavicular nodes will be sufficient for diagnosis if a separate primary lesion of the lung parenchyma is clearly evident on radiographs (i.e., a second biopsy will not be required) * Underwent positron emission tomography (PET) scan within the past 42 days * N2 or N3 mediastinal disease by PET scan OR enlarged nodes on CT scan determined to be N2 or N3 by biopsy * Measurable disease, defined as lesions that can be accurately measured in at least one dimension as ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan * Pleural effusion, ascites, bone lesions, and laboratory parameters are not considered measurable disease * No brain metastases * Malignant pleural effusion allowed provided 1 of the following is true: * Present before mediastinoscopy or exploratory thoracotomy AND the pleural fluid is transudate with negative cytology * Present only after but not before exploratory or staging thoracotomy AND the pleural fluid is either transudate or exudate with negative cytology * Present only on CT scan but not on decubitus chest x-ray AND deemed too small to tap under either CT scan or ultrasound guidance PATIENT CHARACTERISTICS: * Zubrod performance status 0-1, meeting ≥ 1 of the following criteria OR Zubrod performance status 2 with no co-morbidities or meeting 1 of the following criteria: * No co-morbidities * FEV\_1 \< 2 L OR \< 1 L with estimated contralateral FEV\_1 ≥ 0.6 L * DLCO \> 10 mL/mm Hg/min * Albumin \< 0.85 times lower limit of normal * Unintentional weight loss \> 10% within the past 6 months * Controlled congestive heart failure which, in the opinion of the investigator, may become decompensated due to radiotherapy * FEV\_1 \< 2 L OR \< 1 L with estimated contralateral FEV\_1 ≥ 0.6 L * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) * Must provide prior smoking history * Serum bilirubin normal * Meets one of the following criteria: * Alkaline phosphatase (AP) ≤ 4 times ULN AND SGOT or SGPT normal * AP normal AND SGOT or SGPT ≤ 2.5 times ULN * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission * No pregnant or nursing patients * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior chemotherapy or curative surgery for this cancer * No prior radiotherapy to the neck and/or thorax for any reason * No prior therapy which specifically targets the EGFR pathway * No concurrent growth factors (e.g., filgrastim \[G-CSF\], epoetin alfa, or pegfilgrastim) or amifostine * No concurrent intensity-modulated radiotherapy * No concurrent prophylactic mediastinal, contralateral hilar, or supraclavicular lymph node radiotherapy

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 (77)

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, 99508, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, 95901, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Veterans Affairs Medical Center - Denver

Denver, Colorado, 80220, United States

Location

Shaw Regional Cancer Center

Edwards, Colorado, 81632, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Valley View Hospital Cancer Center

Glenwood Springs, Colorado, 81601, United States

Location

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, 81401, United States

Location

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West

Boca Raton, Florida, 33428, United States

Location

Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus

Boca Raton, Florida, 33486, United States

Location

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

Savannah, Georgia, 31403-3089, United States

Location

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, 31603, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Hematology Oncology Consultants - Naperville

Naperville, Illinois, 60540, United States

Location

Hospital District Sixth of Harper County

Anthony, Kansas, 67003, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, 66701, United States

Location

Cancer Center of Kansas-Independence

Independence, Kansas, 67301, United States

Location

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

Kansas City, Kansas, 66160-7357, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Olathe Cancer Center

Olathe, Kansas, 66061, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Cotton-O'Neil Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

Caritas St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135-2997, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Ted B. Wahby Cancer Center at Mount Clemens General Hospital

Mount Clemens, Michigan, 48043, United States

Location

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, 48075, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405-5309, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

Northern Montana Hospital

Havre, Montana, 59501, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology at KRMC

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, 68848-1990, United States

Location

Tucker Center for Cancer Care at Orange Regional Medical Center

Middletown, New York, 10940-4199, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

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

Rochester, New York, 14642, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Pardee Memorial Hospital

Hendersonville, North Carolina, 28791, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MedCentral - Mansfield Hospital

Mansfield, Ohio, 44903, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

MeSH Terms

Conditions

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

Interventions

Cetuximab; Docetaxel; Radiotherapy

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

Results Point of Contact

• Title: Lung Committee Statistician
• Organization: SWOG Statistical Center

206-667-4623

Study Officials

• Yuhchyau Chen, MD, PhD

  James P. Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

• Kishan J. Pandya, MD

  James P. Wilmot Cancer Center

  PRINCIPAL INVESTIGATOR

• Derick H. Lau, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Karen Kelly, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Laurie E. Gaspar, MD, MBA

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: April 1, 2006
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 4, 2013
• Results First Posted: December 25, 2012

Record last verified: 2013-01

Locations

US (77)