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. Isotretinoin and interferon alfa-2b may help paclitaxel work better by making tumor cells more sensitive to the drug. Giving isotretinoin and interferon alfa-2b together with paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alfa-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.

Condition	Intervention	Phase
recurrent cervical cancer stage IVB cervical cancer	Drug: interferon alfa  Drug: isotretinoin  Drug: paclitaxel  Procedure: biological response modifier therapy  Procedure: chemosensitization/potentiation  Procedure: chemotherapy  Procedure: cytokine therapy  Procedure: drug resistance inhibition  Procedure: interferon therapy	Phase II

Further Study Details: 

OBJECTIVES:

• 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically and/or cytologically confirmed cervical cancer, meeting 1 of the following criteria:
• Metastatic disease (stage IVB)
• 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 concurrent 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00138151

New Jersey
      Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08901-2681,  United States; Recruiting
      Carol G. Simon Cancer Center at Morristown Memorial Hospital, Morristown,  New Jersey,  07962,  United States; Recruiting
      Saint Peter''''s University Hospital, New Brunswick,  New Jersey,  08901-1780,  United States; Recruiting

Study chairs or principal investigators

Lorna Rodriguez-Rodriguez, MD, PhD,  Principal Investigator,  Cancer Institute of New Jersey   

Study ID Numbers:  CDR0000433516; CINJ-100101; CINJ-3390; CINJ-NJ1703
Last Updated:  August 29, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00138151
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-30