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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI, Other	CDR0000304430 E6501, NCT00062010

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may reduce resistance to the drug and allow the tumor cells to be killed.

PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works in treating patients with recurrent small cell lung cancer.

Further Study Information

OBJECTIVES:

• Determine the frequency and duration of response in patients with recurrent small cell lung cancer treated with interferon alfa, isotretinoin, and paclitaxel.

• Determine the toxic effects of this regimen in these patients.

• Determine the duration of survival in patients treated with this regimen.

• Correlate the levels of bcl-2 in peripheral blood monocytes with response and survival in patients treated with this regimen.

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.

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

Eligibility Criteria

DISEASE CHARACTERISTICS:

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

• Recurrent disease

• Prior chemotherapy for SCLC required

• Clinically confirmed measurable disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

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

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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Joseph Aisner

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00062010
Information obtained from ClinicalTrials.gov on January 27, 2010

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