Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin

• 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. Combining more than one drug may kill more tumor cells. It is not yet known if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects.

PURPOSE: Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer.

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

Details

• Lead Sponsor: The Christie NHS Foundation Trust
• Treatments: Carboplatin; Cisplatin; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed inoperable non-small cell lung cancer

• Stage IIIA, IIIB, or IV

• Not eligible for curative radiotherapy or surgery

• No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 50-100%

Life expectancy

• At least 12 weeks

Hematopoietic

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 2,000/mm^3

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

• Hemoglobin at least 10 g/dL

Hepatic

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

• AST no greater than 2.5 times ULN

• Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present)

Renal

• Creatinine no greater than ULN OR

• Creatinine clearance at least 60 mL/min

Other

• Not pregnant or nursing

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

• No active infection

• No serious systemic disorder that would preclude study participation

• No grade 2 or greater peripheral neuropathy

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

• No other active malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior cytotoxic chemotherapy

• No other concurrent chemotherapy during or for 7 days after study therapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• No prior radiotherapy

• No concurrent radiotherapy during or for 7 days after study therapy

Surgery

• See Disease Characteristics

Other

• At least 12 weeks since prior investigational agents

• No other concurrent antitumor therapy

• No concurrent experimental medications