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Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer
Not Recruiting
Trial ID: NCT00262821
Purpose
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.
Official Title
A Phase III, Randomized Trial of Weekly Cisplatin and Radiation Versus Cisplatin and Tirapazamine and Radiation in Stage IB2, IIA, IIIB and IVA Cervical Carcinoma Limited to the Pelvis
Stanford Investigator(s)
Eligibility
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
Intervention(s):
drug: cisplatin
drug: tirapazamine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maureen Sutton
6507259167