Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
Condition: Cervical Adenocarcinoma; Cervical Adenosquamous Cell Carcinoma; Cervical Squamous Cell Carcinoma; Stage IB Cervical Cancer; Stage IIA Cervical Cancer; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage IVA Cervical Cancer
MeSH terms: Carcinoma; Uterine Cervical Neoplasms; Carcinoma, Adenosquamous
Intervention: cisplatin; tirapazamine
Intervention description: Given IV; Given IV
Intervention MeSH terms: Tirapazamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 402.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial is studying cisplatin, radiation therapy, and tirapazamine to
      see how well they work compared to cisplatin and radiation therapy in treating patients with
      cervical cancer. Drugs used in chemotherapy, such as cisplatin and tirapazamine, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Internal
      radiation uses radioactive material placed directly into or near a tumor to kill tumor cells.
      Cisplatin and tirapazamine may make tumor cells more sensitive to radiation therapy. It is
      not yet known whether giving cisplatin together with radiation therapy is more effective with
      or without tirapazamine in treating cervical cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or
             adenosquamous cell carcinoma of the uterine cervix

               -  Stage IB2, IIA, IIB, IIIB, or IVA disease

                    -  Stage IIA tumors must be > 4 cm

               -  Primary, untreated disease

          -  Negative, non-suspicious para-aortic nodes by lymphangiogram, CT scan, MRI, or
             lymphadenectomy

          -  Must have been adequately clinically staged

          -  Suitable for treatment with radical intent using concurrent chemotherapy and pelvic
             radiotherapy

          -  No disease involvement of the lower third of the vagina regardless of stage (all stage
             IIIA, IIIB and IVA with lower one-third involvement)

          -  No carcinoma of the cervical stump

          -  Performance status - GOG 0-3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  SGOT ≤ 3 times ULN

          -  Alkaline phosphatase ≤ 3 times ULN

          -  Creatinine ≤ ULN or calculated creatinine clearance ≥ 60mL/min

          -  No New York Heart Association class III-IV heart failure

          -  No history of myocardial infarction

          -  No unstable angina

          -  No uncontrolled hypertension

          -  No pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No septicemia or severe infection

          -  No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

          -  No prior hysterectomy or planned hysterectomy as part of initial cervix cancer therapy

          -  No prior coronary artery bypass surgery

          -  No prior cancer therapy that would preclude study treatment

          -  No concurrent angina medication

          -  No concurrent intensity-modulated radiotherapy