Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery

• Status: Unknown status
• 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. It is not yet known whether paclitaxel and carboplatin is more effective than standard chemotherapy for advanced non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin chemotherapy with that of standard chemotherapy in treating patients who have stage III or stage IV non-small cell lung cancer that cannot be removed during surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Christie NHS Foundation Trust
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Ifosfamide; Isophosphamide mustard; Mitomycin; Mitomycins; Paclitaxel; Vinblastine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed inoperable advanced non-small cell lung cancer

• Stage IIIA, IIIB, or IV

• Not eligible for curative radiotherapy or surgery

• Measurable or evaluable disease

• No bony lesions as only site of measurable disease

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-2 (ECOG 3 allowed in some cases)

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• AST or ALT no greater than 3 times ULN (no greater than 5 times ULN for liver metastases)

Renal:

• Creatinine normal OR

• Creatinine clearance at least 60 mL/min

Other:

• Not pregnant

• Fertile patients must use effective contraception during and for 3 months after study

• No active infection

• No other serious systemic disorder that would preclude compliance

• No second malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer

• No peripheral neuropathy, significant neurological disorders (e.g., seizures), or psychiatric disorders

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• Prior radiotherapy allowed if measurable disease outside of irradiated field

Surgery:

• See Disease Characteristics