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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, United States
UMDNJ University Hospital
Newark, New Jersey, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Response Rate (Complete and Partial)
All patients who receive at least 3 courses of protocol therapy will be considered evaluable for response of measurable disease.
Time frame: 8 years
The Effect of the Regimen on Bcl-2 Family Proteins in Biopsy Specimens and Correlation With Peripheral Blood Mononuclear Cell Bcl-2 Levels.
Time frame: 8 years
The Effect of the Regimen on Raf-1 Kinase Phosphorylation in Biopsy Specimens.
Time frame: 8 years
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