Chemotherapy Followed by Peripheral Stem Cell or Bone Marrow Transplant Compared With Chemotherapy Alone in Treating Patients With 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. Giving chemotherapy with peripheral stem cell transplant or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known whether high-dose chemotherapy plus peripheral stem cell or bone marrow transplant is more effective than chemotherapy alone in treating small cell lung cancer.

PURPOSE: This randomized phase III trial is studying how well chemotherapy followed by peripheral stem cell or bone marrow transplant works compared to chemotherapy alone in treating patients with limited-stage or extensive-stage small cell lung cancer.

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

Details

• Lead Sponsor: EBMT Solid Tumors Working Party
• Treatments: Carboplatin; Epirubicin; Etoposide; Etoposide phosphate; Ifosfamide; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed small cell lung cancer

• Limited disease or extensive disease with no more than 2 metastatic sites

• No CNS metastasis

PATIENT CHARACTERISTICS:

Age:

• 65 and under

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm^3 OR

• Platelet count greater than 100,000/mm^3 OR

• Hemoglobin at least 10.0 g/dL

Hepatic:

• AST/ALT less than 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase less than 2.5 times ULN

• Bilirubin less than 2.5 times ULN

Renal:

• Creatinine clearance at least 60 mL/min

• No renal function that would preclude chemotherapy

Cardiovascular:

• No congestive heart failure

• LVEF at least 50%

• No cardiac function that would preclude chemotherapy

Other:

• No other malignancy within the past 3 years except for basal cell skin cancer or carcinoma in situ of the cervix

• No psychiatric disorder or any other disorder that would preclude study participation

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy

Surgery:

• Not specified