Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer
Cervical Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage IVB cervical cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically and/or cytologically confirmed cervical cancer, meeting 1 of the following criteria: Stage IVB disease Recurrent disease Persistent disease Patients previously treated with chemoradiotherapy as initial therapy must demonstrate disease progression Measurable disease by physical exam or radiographic studies Not amenable to chemoradiotherapy or surgery PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-2 Life expectancy At least 6 months Hematopoietic WBC ≥ 3,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic SGOT and SGPT ≤ 2 times upper limit of normal Bilirubin ≤ 1.5 mg/dL Renal Creatinine ≤ 1.5 mg/dL OR Creatinine clearance ≥ 50 mL/min Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV positivity No active infection No medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No prior interferon No other concurrent immunotherapy Chemotherapy See Disease Characteristics At least 3 months since prior chemoradiotherapy (6 weeks for patients experiencing disease progression after completion of initial chemoradiotherapy) No other prior chemotherapy Endocrine therapy No concurrent hormonal therapy for cancer Radiotherapy See Disease Characteristics See Chemotherapy Recovered from prior radiotherapy No concurrent radiotherapy Surgery Recovered from prior surgery No concurrent surgery for cancer Other No prior retinoids No other concurrent anticancer therapy No other concurrent experimental agents
Sites / Locations
- Cancer Institute of New Jersey at Hamilton
- Carol G. Simon Cancer Center at Morristown Memorial Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Saint Peter's University Hospital
- UMDNJ University Hospital
- Hospital of the University of Pennsylvania
Arms of the Study
Arm 1
Experimental
Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b
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