Official Title: “Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer”

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.

Study Type: Interventional

Study Design: Treatment, Open Label

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.

Intervention(s) in this Clinical Trial

• Drug: isotretinoin
• Drug: paclitaxel
• Drug: recombinant interferon alfa

Primary Measures

• Objective response
  • Safety Issue?: No

Secondary Measures

• Duration of response
  • Safety Issue?: No
• Survival
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eastern Cooperative Oncology Group

Overall Clinical Trial Officials and Contacts

Joseph Aisner, MD Study Chair Cancer Institute of New Jersey  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00062010

Study ID Number: CDR0000304430

ClinicalTrials.gov Identifier: NCT00062010

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database