Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	ECOG-5501 E5501, NCT00057837

Objectives

Primary

1. 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.
2. Evaluate the toxic effects of these regimens in these patients.
3. Evaluate the duration of response and survival of patients treated with these regimens.

Secondary

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

Entry Criteria

Disease Characteristics:

• Diagnosis of extensive stage small cell lung cancer



• Measurable disease



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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• Not specified

Hematopoietic

• WBC at least 4,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Objective response

Duration of response
Survival

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Joseph Aisner, MD, Protocol chair		Ph: 732-235-7401 Email: aisnerjo@umdnj.edu
Eric Rubin, MD, Protocol co-chair		Ph: 732-235-7955

Registry Information
Official Title		A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced with Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced with Etoposide
Trial Start Date		2004-03-24
Trial Completion Date		2008-12-01 (estimated)
Registered in ClinicalTrials.gov		NCT00057837
Date Submitted to PDQ		2003-01-22
Information Last Verified		2008-10-24
NCI Grant/Contract Number		CA21115

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