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

Alternate Title

Interferon alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ECOG-E6501 E6501, NCT00062010

Objectives

1. Determine the frequency and duration of response in patients with recurrent small cell lung cancer treated with interferon alfa, isotretinoin, and paclitaxel.
2. Determine the toxic effects of this regimen in these patients.
3. Determine the duration of survival in patients treated with this regimen.
4. Correlate the levels of bcl-2 in peripheral blood monocytes with response and survival in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed small cell lung cancer (SCLC)
  • Recurrent disease



• Prior chemotherapy for SCLC required



• Clinically confirmed measurable disease

Prior/Concurrent Therapy:

Biologic therapy

• More than 4 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
• No prior interferon alfa
• No concurrent G-CSF or GM-CSF
• Concurrent epoetin alfa allowed

Chemotherapy

• See Disease Characteristics
• More than 60 days since prior chemotherapy
• No prior paclitaxel

Endocrine therapy

• Not specified

Radiotherapy

• More than 60 days since prior radiotherapy

Surgery

• Not specified

Other

• Recovered from prior therapy
• More than 4 weeks since prior administration of any of the following drugs:
  • Ethanol
  • Tetracycline
  • Doxycycline
  • Minocycline
  • Topical acne products (e.g., tretinoin-containing products)
  • Vitamin A
  • Carbamazepine
  • Ketoconazole
  • Phenytoin or other antiepileptic drugs
• No concurrent vitamin supplements containing vitamin A during isotretinoin administration

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• AST no greater than 2 times upper limit of normal (ULN)

Renal

• Creatinine no greater than 1.5 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception for 1 month before, during, and for 1 month after study treatment
• Triglycerides no greater than 1.5 times ULN
• No other prior malignancy except nonmetastatic, nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy more than 5 years prior to study entry
• No severe (≥ grade 2) depression requiring medication

Expected Enrollment

A total of 37-83 patients will be accrued for this study.

Outcomes

Objective response

Duration of response
Survival

Outline

This is a multicenter study.

Patients receive interferon alfa subcutaneously and oral isotretinoin on days 1 and 2 and paclitaxel IV over 1 hour on day 2 of weeks 1-6. Courses repeat every 8 weeks 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

Registry Information
Official Title		Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer
Trial Start Date		2004-02-24
Registered in ClinicalTrials.gov		NCT00062010
Date Submitted to PDQ		2003-04-21
Information Last Verified		2007-09-06
NCI Grant/Contract Number		CA21115

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