Isotretinoin, Interferon Alpha-2b, and Paclitaxel in Stage IV, Recurrent, or Persistent Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: recombinant interferon alpha-2b; isotretinoin; paclitaxel
Intervention description: 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
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Paclitaxel; Isotretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent cervical cancer; stage IVB cervical cancer

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.
    

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