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

Lung Cancer Clinical Trial

Official title:

A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006004
• Other study ID #: CDR0000068012
• Secondary ID: E-1599
• Status: Completed
• Phase: Phase 2
• Start date: August 22, 2000

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• cisplatin

• gemcitabine hydrochloride

• paclitaxel

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales
Peru	Instituto de Enfermedades Neoplasicas	Lima
Puerto Rico	San Juan City Hospital	San Juan
United States	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Iowa Lutheran Hospital	Des Moines	Iowa
United States	Iowa Methodist Medical Center	Des Moines	Iowa
United States	Mercy Medical Center	Des Moines	Iowa
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Alegent Health-Midlands Community Hospital	Papillion	Nebraska
United States	James P. Wilmot Cancer Center	Rochester	New York
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	CCOP - Oklahoma	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Peru,  Puerto Rico, 

References & Publications (3)

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- — View Citation

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

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 1