Conditions: Cervical Cancer
Keywords: recurrent cervical cancer stage IVB cervical cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 33
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: * Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
* Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
* Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days

Interventions: intervention 1: recombinant interferon alpha-2b intervention 2: isotretinoin intervention 3: paclitaxel
Intervention descriptions: intervention 1: Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle intervention 2: Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle intervention 3: Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days

Protocol document: