Comparison of Four Combination Chemotherapy Regimens Using Cisplatin in Treating Patients With Stage IVB, Recurrent, or Persistent Cancer of the Cervix
Condition: Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Recurrent Cervical Carcinoma; Stage IVB Cervical Cancer
MeSH terms: Carcinoma; Carcinoma, Adenosquamous; Recurrence
Intervention: Cisplatin; Gemcitabine Hydrochloride; Paclitaxel; Quality-of-Life Assessment; Topotecan Hydrochloride; Vinorelbine Tartrate
Intervention description: Given IV; Given IV; Ancillary studies; Given IV; Given IV
Intervention MeSH terms: Paclitaxel; Vinorelbine; Cisplatin; Gemcitabine; Albumin-Bound Paclitaxel; Topotecan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 513.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial is studying four combination chemotherapy regimens using
      cisplatin to compare how well they work in treating women with stage IVB, recurrent, or
      persistent cancer of the cervix. Drugs used in chemotherapy such as cisplatin, paclitaxel,
      vinorelbine, gemcitabine, and topotecan, use different ways to stop tumor cells from dividing
      so they stop growing or die. It is not yet known which combination chemotherapy regimen
      containing cisplatin is most effective in treating cervical cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or
             adenocarcinoma of the cervix

               -  Stage IVB, recurrent, or persistent disease

          -  Not amenable to curative surgery and/or radiotherapy

          -  At least 1 unidimensionally measurable lesion

               -  At least 20 mm by palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by
                  spiral CT scan

               -  Biopsy confirmation required if lesion is less than 30 mm

               -  Target lesion must be outside of a previously irradiated field

          -  No craniospinal metastases

          -  Performance status - GOG 0-1

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Bilirubin no greater than 1.5 times normal

          -  Alkaline phosphatase no greater than 3 times normal

          -  AST no greater than 3 times normal

          -  Creatinine ≤ 1.2 mg/dL

          -  Creatinine > 1.2 mg/dL but < 1.5 mg/dL AND creatinine clearance ≥ 50 mL/min

          -  No bilateral hydronephrosis not alleviated by ureteral stents or percutaneous drainage

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No prior or concurrent malignancy within the past 5 years except nonmelanoma skin
             cancer

          -  No prior malignancy whose treatment contraindicates the current study therapy

          -  No concurrent clinically significant infection

          -  No concurrent cytokines

          -  At least 6 weeks since prior chemoradiotherapy and recovered

          -  No prior chemotherapy (except when concurrently administered with radiotherapy)

          -  At least 3 weeks since prior radiotherapy and recovered

          -  Recovered from prior surgery