Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer

Completed · Phase 1

Conditions studied: Cervical Adenocarcinoma, 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 phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

Key facts

Study ID

NCT00054444

Run by

Gynecologic Oncology Group

People needed

11

Starts

2007-09-01

Last updated by the study team

2014-12-31

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed primary invasive carcinoma of the uterine cervix
• Stages IB2, II, IIIB, and IVA disease
• Any cell type
• No known metastasis to scalene nodes or organs outside the radiation field
• No known intraperitoneal metastases
• No evidence of extrapelvic disease based on negative CT or PET scan
• Must enroll within 8 weeks of diagnosis
• Performance status - GOG 0-2
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine normal
• Creatinine clearance > 50 mL/min
• Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed
• No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except nonmelanoma skin cancer
• No septicemia or severe infection
• No other medical or psychiatric condition that would preclude study compliance
• No prior chemotherapy for any prior malignancy
• No prior cytotoxic chemotherapy for this malignancy

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Missouri - Ellis Fischel — Columbia, Missouri, United States
• Cooper Hospital University Medical Center — Camden, New Jersey, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
• Riverside Methodist Hospital — Columbus, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Cancer Care Associates-Midtown — Tulsa, Oklahoma, United States
• Tulsa Cancer Institute — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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