Cervical Adenocarcinoma Clinical Trial
Official title:
A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS
Verified date | December 2014 |
Source | Gynecologic Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 - No prior radiotherapy for any prior malignancy - No prior pelvic or abdominal radiotherapy for this malignancy - No prior therapy for this malignancy |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cooper Hospital University Medical Center | Camden | New Jersey |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | University of Missouri - Ellis Fischel | Columbia | Missouri |
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 Iowa Hospitals and Clinics | Iowa City | Iowa |
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 |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0 | Up to 30 days after completion of radiation therapy | Yes | |
Primary | Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC) | Up to 5 years | Yes | |
Secondary | Site of treatment failure | Identified as local versus distant. | Up to 5 years | No |
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