Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer

Completed · Phase 1

Conditions studied: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Small 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 phase I trial is studying the side effects and best dose of gemcitabine when given together with radiation therapy and cisplatin in treating patients with cervical cancer that has not spread beyond the pelvis. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining cisplatin with gemcitabine may make the tumor cells more sensitive to radiation therapy and may kill more tumor cells.

Key facts

Study ID

NCT00068549

Run by

Gynecologic Oncology Group

People needed

13

Starts

2003-10-01

Last updated by the study team

2014-12-25

Who can join

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

You may qualify if…

• Histologically confirmed primary invasive carcinoma of the uterine cervix
• Previously untreated disease
• Any cell type
• Stage IB_2, IIA, IIB, IIIA, IIIB, or IVA
• Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy
• No known metastases to scalene nodes or other organs outside the radiotherapy field
• Study enrollment within 8 weeks of diagnosis
• Performance status - GOG 0-2
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 times normal
• SGOT no greater than 3 times normal
• Creatinine less than 2.0 mg/dL
• No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields
• No ureteral obstruction allowed unless treated with stent or nephrostomy tube
• Not pregnant
• Fertile patients must use effective contraception
• No septicemia or severe infection
• No circumstance that would preclude study completion or follow-up
• No other malignancy within the past 5 years except nonmelanoma skin cancer
• No prior cytotoxic chemotherapy
• No prior pelvic or abdominal radiotherapy
• No prior therapy for this malignancy

Where it is running

• Gynecologic Oncology Group — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.