Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

OBJECTIVES:

Primary

• Evaluate the response frequency of patients with extensive stage small cell lung cancer treated with topotecan, cisplatin, and etoposide and with irinotecan, cisplatin, and etoposide.

• Evaluate the toxic effects of these regimens in these patients.

• Evaluate the duration of response and survival of patients treated with these regimens.

Secondary

• Correlate the occurrence of various BRCP polymorphisms with clinical response and toxicity in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive topotecan IV over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.

• Arm II: Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 60-140 patients (30-70 per treatment arm) will be accrued for this study within 7-16 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of extensive stage small cell lung cancer

• Measurable disease

• CNS metastases allowed if previously treated and with no advancing symptoms

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• Not specified

Hematopoietic

• WBC at least 4,000/mm^3

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

Hepatic

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

• AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal

• Creatinine clearance at least 30 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Concurrent epoetin alfa allowed provided treatment was initiated before study entry

Chemotherapy

• No prior chemotherapy for this disease

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for lung cancer

• Prior radiotherapy for brain metastases allowed

Surgery

• Not specified

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Joseph Aisner

Study Chair

Eric H. Rubin

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00057837
Information obtained from ClinicalTrials.gov on January 10, 2012

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