Combination Chemotherapy in Treating Patients Who Have Extensive-Stage 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. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective for extensive-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer.

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

Details

• Lead Sponsor: Commissie Voor Klinisch Toegepast Onderzoek
• Treatments: Carboplatin; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Liposomal doxorubicin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven extensive stage small cell lung cancer, not previously treated with chemotherapy or radiotherapy except for symptomatic brain metastases

• Measurable or evaluable disease

• Ascites, pleural effusions, osteolytic and osteoblastic bone metastases are not measurable or evaluable

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

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

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

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (unless due to liver metastases)

Renal:

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No cardiac failure or rhythm disturbances requiring medication

Other:

• No history of hypersensitivity to castor oil

• No active uncontrolled infection

• No nonmalignant disease presenting a poor medical risk

• Not pregnant

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• See Disease Characteristics

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy

Radiotherapy:

• See Disease Characteristics

• Palliative radiotherapy allowed (indicator lesion should be outside of irradiated field)

Surgery:

• Not specified