Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2012-08-01
• 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 in treating extensive-stage small cell lung cancer.

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

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Cisplatin; Etoposide; Etoposide phosphate; Irinotecan; Lenograstim; Podophyllotoxin; Sargramostim; Topoisomerase Inhibitors; Topotecan

Criteria

INCLUSION CRITERIA:

• Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated within 2 weeks prior to randomization

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3

• Disease-free for >=5 years if had a prior second malignancy other than treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix

• Adequate hematologic, hepatic and renal function determined by the following tests, within 4 weeks prior to randomization: white blood cell (WBC) >=4000/mm3 and platelets >=100,000/mm3; bilirubin <= upper limit of normal; serum glutamic pyruvate transaminase (SGPT) or alanine transaminase (ALT) and serum glutamic oxaloacetic transaminase (SGOT) or aspartate transaminase( AST) <=2.5 x upper limit of normal if no demonstrable liver metastases or <=5 times upper limit of normal in the presence of liver metastases; Calculated creatinine clearance >=30 using the formulas in the protocol

• Age 18 and older

• Strongly advised to use an accepted and effective method of contraception

• Those with central nervous system (CNS) metastases were eligible if the metastases were treated without advancing symptoms prior to the initiation of chemotherapy

• Those receiving erythropoietin could continue to receive it

EXCLUSION CRITERIA:

• Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central nervous system (CNS) metastases

• Prior chemotherapy for this disease

• Pregnant or lactating