Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer

• Status: Terminated
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Interferon alpha-2; Interferon-alpha; Interferons; Isotretinoin; Paclitaxel; Tretinoin

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