Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
This study has been completed.
Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00062010
First received: June 5, 2003
Last updated: December 1, 2012
Last verified: December 2012
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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: interferon alpha Drug: 13-cis-retinoic acid Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment 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 |
Resource links provided by NLM:
Drug Information available for:
Tretinoin
Isotretinoin
Interferon
Paclitaxel
Interferon Alfa-2a
Interferon Alfa-2b
U.S. FDA Resources
Further study details as provided by Eastern Cooperative Oncology Group:
Primary Outcome Measures:
- Response by RECIST Criteria (v 1.0) [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]Number of eligible, treated participants in each response category by RECIST criteria
Secondary Outcome Measures:
- Survival [ Time Frame: Assessed every 3 months for 1 year then every 6 months ] [ Designated as safety issue: No ]Time from registration to death.
- Progression-free Survival [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]Time from registration to documented disease progression (RECIST criteria) or death.
| Enrollment: | 37 |
| Study Start Date: | February 2004 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IFN-alpha, 13-CRA, paclitaxel
Interferon alpha: 6 million U/m2 on days 1 and 2 of each week for 6 weeks of an 8-week cycle 13-cis-retinoic acid: 1 mg/kg on days 1 and 2 of each week for 6 weeks of an 8-week cycle Paclitaxel: 75 mg/m2 on day 2 of each week for 6 weeks of an 8-week cycle
|
Biological: interferon alpha
Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
Other Names:
Drug: 13-cis-retinoic acid
13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
Other Names:
Drug: paclitaxel
paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
Other Names:
|
Detailed Description:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) with clinically confirmed measurable disease
- Age 18 and over
- ECOG Performance status 0-3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 2 times upper limit of normal (ULN)
- Creatinine no greater than 1.5 mg/dL
- Triglycerides no greater than 1.5 times ULN
- Patients must have had prior chemotherapy treatment for SCLC, and toxicities must have resolved to less than or equal to grade 1
- Women of childbearing potential and sexually active males are strongly encouraged to use an accepted and effective method of contraception.
Exclusion Criteria
- History of another neoplasm other than SCLC except for non-metastatic, non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy at least 5 years before registration
- Pregnant or nursing, with a negative pregnancy test within 2 weeks prior to registration
- Severe depression requiring medication
- Use of the following drugs within 4 weeks prior to registration: carbamazepine, ethanol, tetracycline, doxycycline, minocycline, topical acne products containing Retin-A, vitamin A, cisplatin, ketoconazole, phenytoin or other antiepileptic drugs
- Use of GM-CSF or G-CSF within 4 weeks prior to registration
- Prior paclitaxel or interferon therapy
- Radiation therapy within 60 days prior to registration
- Chemotherapy within 60 days prior to registration
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062010
Show 73 Study Locations
Show 73 Study LocationsSponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
| Study Chair: | Joseph Aisner, MD | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00062010 History of Changes |
| Other Study ID Numbers: | CDR0000304430, E6501 |
| Study First Received: | June 5, 2003 |
| Results First Received: | December 1, 2012 |
| Last Updated: | December 1, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eastern Cooperative Oncology Group:
|
recurrent small cell lung cancer |
Additional relevant MeSH terms:
|
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 Interferon Alfa-2b Interferons Reaferon |
Tretinoin 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 Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 23, 2013