Tirapazamine, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
Cervical Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix Stage IB, IIA, IIB, III, or IVA disease No evidence of involvement of para-aortic nodes by CT scan, MRI, fluorodeoxyglucose positron emission tomography, or lymphadenectomy Involvement of common iliac nodes allowed No evidence of distant metastases PATIENT CHARACTERISTICS: Age Any age Performance status ECOG 0-2 Life expectancy More than 6 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin < 1.25 times upper limit of normal (ULN) AST and ALT ≤ 3 times ULN Renal Calculated creatinine clearance ≥ 60 mL/min OR Glomerular filtration rate ≥ 60 mL/min Cardiovascular No significant cardiac disease that would preclude IV fluid load required for administration of cisplatin No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other No symptomatic peripheral neuropathy ≥ grade 2 No clinically significant sensori-neural hearing impairment interfering with activities of daily living or requiring a hearing aid Audiometric changes alone of any severity allowed No history of allergic reaction attributed to compounds of similar chemical or biological composition to tirapazamine or cisplatin No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent epoetin alfa No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) No concurrent pegfilgrastim Chemotherapy No prior chemotherapy for another malignancy Endocrine therapy Not specified Radiotherapy No prior pelvic or abdominal radiotherapy for another malignancy No prior radiotherapy to ≥ 15% of bone marrow-bearing areas No concurrent intensity-modulated radiotherapy No concurrent interstitial brachytherapy Surgery Not specified Other No prior treatment for invasive cervical cancer No other concurrent therapeutic investigational agents No other concurrent anticancer therapy No concurrent systemic retinoids No concurrent amifostine No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Peter MacCallum Cancer Centre
- Princess Margaret Hospital