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NCT00085501

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

Last Updated: 2012-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

Primary

* Compare overall survival of patients with selected stage IIIB or stage IV non-small cell lung cancer treated with concurrent vs sequential paclitaxel, carboplatin, and cetuximab.

Secondary

* Compare response rates (confirmed and unconfirmed, complete and partial) in patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
* Correlate epidermal growth factor receptor polymorphisms and downstream biomarkers with response to cetuximab in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I (concurrent cetuximab): Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8, and 15 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 8. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour once weekly in the absence of disease progression or unacceptable toxicity.
* Arm II (sequential cetuximab): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour (over 2 hours on week 13 only) once weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study within 9 months.

Conditions

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Lung Cancer

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

cetuximab

Intervention Type 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.

carboplatin

Intervention Type 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

paclitaxel

Intervention Type 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.

2

Group Type ACTIVE_COMPARATOR

cetuximab

Intervention Type DRUG

carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Interventions

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cetuximab

Intervention Type DRUG

carboplatin

Intervention Type DRUG

paclitaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roy S. Herbst, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Karen Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

David R. Gandara, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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Alaska Regional Hospital

Anchorage, Alaska, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Site Status

Peninsula Medical Center

Burlingame, California, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Marin Cancer Institute at Marin General Hospital

Greenbrae, California, United States

Site Status

Sutter Health Western Division Cancer Research Group

Greenbrae, California, United States

Site Status

Saint Rose Hospital

Hayward, California, United States

Site Status

Valley Memorial Hospital

Livermore, California, United States

Site Status

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

Site Status

Highland General Hospital

Oakland, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Summit Medical Center

Oakland, California, United States

Site Status

Comprehensive Cancer Center at Desert Regional Medical Center

Palm Springs, California, United States

Site Status

Sutter Roseville Medical Center

Roseville, California, United States

Site Status

Sutter Cancer Center

Sacramento, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

Mercy General Hospital

Sacramento, California, United States

Site Status

California Pacific Medical Center - California Campus

San Francisco, California, United States

Site Status

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

San Pablo, California, United States

Site Status

CCOP - Santa Rosa Memorial Hospital

Sana Rosa, California, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

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

Denver, Colorado, United States

Site Status

Veterans Affairs Medical Center - Denver

Denver, Colorado, United States

Site Status

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status

Montrose Memorial Hospital Cancer Center

Montrose, Colorado, United States

Site Status

St. Anthony North Hospital

Westminster, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

CCOP - Atlanta Regional

Atlanta, Georgia, United States

Site Status

Northside Hospital Cancer Center

Atlanta, Georgia, United States

Site Status

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Site Status

Augusta Oncology Associates

Augusta, Georgia, United States

Site Status

WellStar Cobb Hospital

Austell, Georgia, United States

Site Status

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, United States

Site Status

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Site Status

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Site Status

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, United States

Site Status

Southern Regional Medical Center

Riverdale, Georgia, United States

Site Status

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

Savannah, Georgia, United States

Site Status

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, United States

Site Status