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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Gemcitabine; Paclitaxel

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