Cisplatin and Radiation Therapy With or Without Tirapazamine in Treating Patients With Cervical Cancer

Stopped early · Phase 3

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00262821

Run by

National Cancer Institute (NCI)

People needed

402

Starts

2006-02-01

Expected to finish

2010-08-01

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Mobile Infirmary Medical Center — Mobile, Alabama, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Western Regional CCOP — Phoenix, Arizona, United States
• Highlands Oncology Group PA - Fayetteville — Fayetteville, Arkansas, United States
• Washington Regional Medical Center - Fayetteville — Fayetteville, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• City of Hope Medical Center — Duarte, California, United States
• Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Bay Area Tumor Institute CCOP — Oakland, California, United States
• University of California Medical Center At Irvine-Orange Campus — Orange, California, United States
• Pomona Valley Hospital Medical Center — Pomona, California, United States
• Stanford University Hospitals and Clinics — Stanford, California, United States
• Olive View-University of California Los Angeles Medical Center — Sylmar, California, United States
• Colorado Gynecologic Oncology Group — Aurora, Colorado, United States
• Memorial Hospital Colorado Springs — Colorado Springs, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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