Cervical Cancer Clinical Trial
Official title:
A Phase II Trial of Chemosensitization With Paclitaxel, 13-cis Retinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor
is said to be resistant to chemotherapy. Giving isotretinoin and interferon alpha-2b
together with paclitaxel may reduce drug resistance and allow the tumor cells to be killed.
PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon
alpha-2b together with paclitaxel works in treating patients with stage IV, recurrent, or
persistent cervical cancer.
OBJECTIVES:
- Determine the response in patients with stage IVB, recurrent, or persistent cervical
cancer treated with isotretinoin, interferon alpha-2b, and paclitaxel.
OUTLINE: This is a multicenter study.
Patients receive oral isotretinoin and interferon alpha-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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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