Radiation Therapy, Paclitaxel, and Cisplatin in Treating Patients With Cancer of the Cervix
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: cisplatin; paclitaxel; brachytherapy; radiation therapy
Intervention MeSH terms: Paclitaxel; Cisplatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III cervical cancer; stage IVA cervical cancer; cervical squamous cell carcinoma; cervical adenocarcinoma; cervical adenosquamous cell carcinoma

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and
      cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more
      sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells
      from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may
      kill more tumor cells.

      PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when
      given with radiation therapy and cisplatin and to see how well they work in treating patients
      with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven previously untreated invasive carcinoma of the uterine cervix

               -  Squamous cell carcinoma

               -  Adenosquamous carcinoma

               -  Adenocarcinoma

          -  TNM classification stage IIIB or IVA (FIGO classification stage IB, IIA, IIB, IIIA,
             IIIB, or IVA)

          -  Cytologically or histologically proven metastases to the para-aortic lymph nodes

          -  No more than 8 weeks since diagnosis

          -  No metastases to scalene nodes, intraperitoneal metastases, or metastases to other
             organs outside the radiation field at the time of original clinical and surgical
             staging

               -  Negative CT scan of the chest

          -  Patients with ureteral obstruction must be treated with stent or nephrostomy tube

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  GOG 0-2

        Life expectancy:

          -  At least 6 months

        Hematopoietic:

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  Bilirubin no greater than 1.5 times normal

          -  SGOT no greater than 3 times normal

        Renal:

          -  Creatinine less than 2.0 mg/dL

          -  No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal
             transplantation) requiring modification of radiation fields

        Other:

          -  Not pregnant

          -  No septicemia or severe infection

          -  No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  No prior cytotoxic chemotherapy for this or other malignancy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiotherapy for this or other malignancy

          -  No prior radiotherapy to pelvis or abdomen

        Surgery:

          -  Not specified

        Other:

          -  No other prior therapy for this malignancy