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Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer Clinical research trials and Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer. Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer  Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
For Condition: Cervical Cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: 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. PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with cisplatin and gemcitabine in treating patients who have cervical cancer that has not spread beyond the pelvis.
Details: OBJECTIVES: Primary - Determine the toxicity of pelvic radiotherapy and concurrent cisplatin and gemcitabine in patients with cervical carcinoma limited to the pelvis. - Determine the maximum tolerated dose (MTD) of gemcitabine in combination with cisplatin and pelvic radiotherapy in these patients. Secondary - Determine the progression-free and overall survival of patients treated with gemcitabine at the MTD in this regimen. - Determine the site of recurrence, local versus distant, in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of gemcitabine. Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36 in the absence of disease progression or unacceptable toxicity. Patients also undergo external whole pelvis radiotherapy once daily on days 1-5, 8-13, 15-20, 22-27, and 29-34. After completion of external beam radiotherapy, patients undergo intracavitary radiotherapy and parametrial radiotherapy. The total elapsed time for completion of all radiotherapy is not more than 8 weeks. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-4 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 PATIENT CHARACTERISTICS: Age - Not specified Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times normal - SGOT no greater than 3 times normal Renal - 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 Other - 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 PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior cytotoxic chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior pelvic or abdominal radiotherapy Surgery - Not specified Other - No prior therapy for this malignancy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterRose, Study Chair, Ireland Cancer Center
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting Marta Crispens 615-322-2114
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Saint Joseph Regional Medical Center *Recruiting*
South Bend, Indiana, 46617
United States
Recruiting Michael Method 574-237-8010
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-1000
United States
Recruiting Deborah Armstrong 410-614-2743
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting David Mutch 314-362
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Ira Horowitz 404-727-9876
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville, Tennessee, 37917
United States
Recruiting Kenneth Cofer 865-673-9250
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting Joseph Kelley 412-641-5418
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Nava Siegelmann-Danieli 570-271-6834
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Peter Rose 216-844-5011
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
Tampa Bay Cancer Consortium *Recruiting*
Saint Petersburg, Florida, 33701
United States
Recruiting James Fiorica 813-893-6193
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
Gynecologic Oncology Network *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Howard Homesley 615-804-2216
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62794-9640
United States
Recruiting L. Massad 217-545-8882
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Mark Morgan 215-662-6043
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
Additional Information:
Study ID Numbers: CDR0000327715; GOG-9912
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068549
Other Cervical Cancer Studies:
1. Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
2. Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer
3. Liposomal Doxorubicin and Carboplatin in Treating Patients With Gynecologic Cancer
4. Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results
5. Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
Related Studies:
Other Cervical Cancer Clinical Trials
Other Michigan Clinical Trials
Other Ann Arbor Clinical Trials
Radiation Therapy Plus Cisplatin and Gemcitabine in Treating Patients With Cervical Cancer
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