Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer

NCT ID: NCT00006004

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-08-22

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for treating non-small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have non-small cell lung cancer.

Detailed Description

OBJECTIVES:

• Compare overall survival, response rate, and time to progression of patients with non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine and cisplatin.
• Compare the toxicities of each of these 2 regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the past 6 months (less than 5% vs at least 5%) and disease stage (stage IIIB with pleural or pericardial effusion or pleural implants vs stage IV/recurrent). Patients are randomized to one of two treatment arms.

• Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1.
• Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 only.

Treatment continues in both arms every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this study within 12 months.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung carcinoma of any of the following subtypes:

• Squamous cell
• Adenocarcinoma
• Large cell anaplastic
• Bronchioalveolar
• Non-small cell carcinoma not otherwise specified
• No small cell anaplastic elements allowed
• Must have:

• Recurrent disease after prior radiotherapy or surgery OR
• Stage IV disease with distant metastases OR
• Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest x-ray or pleural implants documented pathologically or on CT or chest x-ray
• Bidimensionally measurable or evaluable disease
• Brain metastases allowed provided clinically stable after treatment with surgery and/or radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No uncontrolled high blood pressure, unstable angina, or congestive heart failure
• No myocardial infarction within the past 6 months
• No serious ventricular arrhythmias requiring medication

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other active malignancies requiring ongoing treatment
• No uncontrolled serious active infections
• No suspected hypersensitivity to agents that utilize Cremophor
• No evidence of neuropathy grade 2 or greater by history or physical examination

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for non-small cell lung cancer

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy to only site of measurable or evaluable disease unless subsequent progression documented by physical exam, radiograph, or pathology
• Recovered from prior radiotherapy
• No concurrent radiotherapy except for whole brain radiation for developing brain metastases

Surgery:

• See Disease Characteristics

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Corey J. Langer, MD

Role: STUDY_CHAIR

Fox Chase Cancer Center

Locations

Emory University Hospital - Atlanta

Atlanta, Georgia, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Mercy Medical Center

Des Moines, Iowa, United States

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Alegent Health-Midlands Community Hospital

Papillion, Nebraska, United States

CCOP - Northern New Jersey

Hackensack, New Jersey, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

MBCCOP - University of New Mexico HSC

Albuquerque, New Mexico, United States

James P. Wilmot Cancer Center

Rochester, New York, United States

CCOP - Oklahoma

Tulsa, Oklahoma, United States

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

CCOP - Scott and White Hospital

Temple, Texas, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, United States

Westmead Hospital

Westmead, New South Wales, Australia

Instituto de Enfermedades Neoplasicas

Lima, , Peru

San Juan City Hospital

San Juan, , Puerto Rico

Countries

United States; Australia; Peru; Puerto Rico

References

Langer C, Li S, Schiller J, Tester W, Rapoport BL, Johnson DH; Eastern Cooperative Oncology Group. Randomized phase II trial of paclitaxel plus carboplatin or gemcitabine plus cisplatin in Eastern Cooperative Oncology Group performance status 2 non-small-cell lung cancer patients: ECOG 1599. J Clin Oncol. 2007 Feb 1;25(4):418-23. doi: 10.1200/JCO.2005.04.9452.

Reference Type: RESULT

PMID: 17264337 (View on PubMed)

Tester WJ, Stephenson P, Langer CJ, et al.: ECOG 1599: randomized phase II study of paclitaxel/carboplatin or gemcitabine/cisplatin in performance status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 22 (Suppl 14): A-7055, 630s, 2004.

Reference Type: RESULT

Langer CJ, Stephenson P, Schiller J, et al.: ECOG 1599: randomized phase II study of paclitaxel/carboplatin vs cisplatin/gemcitabine in performance status (PS) 2 patients with treatment-naive advanced NSCLC. [Abstract] Lung Cancer 41 (Suppl 2): A-O52, S18, 2003.

Reference Type: RESULT

Other Identifiers

E-1599

Identifier Type: -

Identifier Source: secondary_id

CDR0000068012

Identifier Type: -

Identifier Source: org_study_id