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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00062010 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: recombinant interferon alfa Drug: isotretinoin Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer |
| Estimated Enrollment: | 83 |
| Study Start Date: | February 2004 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer (SCLC)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 4 weeks since prior administration of any of the following drugs:
Contacts and Locations
Show 73 Study Locations| Study Chair: | Joseph Aisner, MD | Cancer Institute of New Jersey |
More Information
| Responsible Party: | Group Chair, Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00062010 History of Changes |
| Other Study ID Numbers: | CDR0000304430, E6501 |
| Study First Received: | June 5, 2003 |
| Last Updated: | January 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent small cell lung cancer |
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Interferon-alpha Interferon Alfa-2a Interferons Paclitaxel Isotretinoin |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Dermatologic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators |