Gemcitabine Plus Supportive Care in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• 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. Treatment plus supportive care may improve quality of life in patients undergoing cancer treatment.

PURPOSE: Randomized phase II/III trial to compare the effect of different gemcitabine regimens plus supportive care on quality of life in patients who have locally advanced or metastatic non-small cell lung cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Christie NHS Foundation Trust
• Treatments: Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven locally advanced or metastatic non-small cell lung cancer that is not amenable to curative surgery or radiotherapy

• No known CNS metastases

• No concurrent cord compression or superior vena cava syndrome requiring immediate radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 40-70%

Life expectancy:

• At least 4 weeks

Hematopoietic:

• WBC at least 3,500/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin at least 10.0 g/dL

Hepatic:

• Bilirubin no greater than 3 times normal

• ALT and AST no greater than 3 times normal (5 times normal if liver metastasis present)

Renal:

• Creatinine no greater than 1.5 times normal

Other:

• Not pregnant or nursing

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

• No active infection

• No other concurrent serious, systemic disorder that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

• No other concurrent systemic chemotherapy

Endocrine therapy:

• Concurrent steroids allowed

Radiotherapy:

• See Disease Characteristics

• Concurrent palliative radiotherapy allowed

• No concurrent curative radiotherapy

Surgery:

• See Disease Characteristics

• Concurrent palliative surgery allowed