Phase 2
N=37
Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00062010 ↗Enrolled (actual)
37
Serious AEs
61.8%
Results posted
Jan 2013
Primary outcome: Primary: Response by RECIST Criteria (v 1.0) — 3; 5; 11; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- interferon alpha (Biological); 13-cis-retinoic acid (Drug); paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Cooperative Oncology Group
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response by RECIST Criteria (v 1.0) |
3; 5; 11; 15 | — |
| SECONDARY Survival |
6.2 | — |
| SECONDARY Progression-free Survival |
2.0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00062010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.