A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
- Determine the response in patients with stage IVB, recurrent, or persistent cervical
cancer treated with isotretinoin, interferon alfa-2b, and paclitaxel.
OUTLINE: This is a multicenter study.
Patients receive oral isotretinoin and interferon alfa-2b subcutaneously once daily on days
1-4 and paclitaxel IV over 3 hours on day 4. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 27-66 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete and partial)
Lorna Rodriguez, MD, PhD
Cancer Institute of New Jersey
United States: Food and Drug Administration
|Carol G. Simon Cancer Center at Morristown Memorial Hospital||Morristown, New Jersey 07962|
|UMDNJ University Hospital||Newark, New Jersey 07103|
|Cancer Institute of New Jersey at Hamilton||Hamilton, New Jersey 08690|
|Saint Peter's University Hospital||New Brunswick, New Jersey 08901-1780|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|