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

Phase 2
Completed
Conditions
Lung Cancer
Interventions
Registration Number
NCT00085501
Lead Sponsor
SWOG Cancer Research Network
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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
242
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
2cetuximab-
2carboplatin-
2paclitaxel-
1cetuximab-
1carboplatin-
1paclitaxel-
Primary Outcome Measures
NameTimeMethod
Select a regimen based on overall survivalFrom date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

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.

Response rate (confirmed and unconfirmed, complete and partial response)From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

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.

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

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

Secondary Outcome Measures
NameTimeMethod
Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with responseAt prestudy

To conduct exploratory molecular correlative studies of the EGFR-HER signaling pathways examining activated phosphoproteins, oncogenic mutations and rates of proliferation and apoptosis in patient tissues (see S9925 for details).

Evaluate EGFR polymorphismsAt prestudy and week 5

To evaluate EGFR polymorphisms as a potential correlate for response to cetuximab (see S9925 for details).

Trial Locations

Locations (162)

Alaska Regional Hospital

🇺🇸

Anchorage, Alaska, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Alta Bates Comprehensive Cancer Center

🇺🇸

Berkeley, California, United States

Peninsula Medical Center

🇺🇸

Burlingame, California, United States

City of Hope Comprehensive Cancer Center

🇺🇸

Duarte, California, United States

Marin Cancer Institute at Marin General Hospital

🇺🇸

Greenbrae, California, United States

Sutter Health Western Division Cancer Research Group

🇺🇸

Greenbrae, California, United States

Saint Rose Hospital

🇺🇸

Hayward, California, United States

Valley Memorial Hospital

🇺🇸

Livermore, California, United States

USC/Norris Comprehensive Cancer Center and Hospital

🇺🇸

Los Angeles, California, United States

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Alaska Regional Hospital
🇺🇸Anchorage, Alaska, United States

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