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A Phase I Study Using Low Dose Abdominal Radiotherapy as A Docetaxel Chemosensitizer for Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer
Phase I trial to study the effectiveness of low-dose radiation therapy to the abdomen combined with docetaxel in treating patients who have recurrent or persistent advanced ovarian, peritoneal, or fallopian tube cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.
OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel in combination with low-dose abdominal radiotherapy in patients with recurrent or persistent advanced ovarian, peritoneal, or fallopian tube cancer. II. Determine the safety and toxicity of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of docetaxel. Patients receive docetaxel IV over 30 minutes once daily on days 1, 8, 15, 22, 29, and 35. Within 3 hours after beginning docetaxel, patients also receive low-dose abdominal radiotherapy twice daily (at least 4 hours apart) on days 1, 2, 8, 9, 15, 16, 22, 24, 29, 30, 35, and 36. Treatment continues in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Case Western Reserve University
Cleveland, Ohio, United States
Lake University Ireland Cancer Center
Mentor, Ohio, United States
Cancer Care Associates-Midtown
Tulsa, Oklahoma, United States
Start Date
September 1, 2003
Primary Completion Date
July 1, 2010
Last Updated
February 11, 2016
13
ACTUAL participants
3-Dimensional Conformal Radiation Therapy
RADIATION
Chemosensitization/Potentiation Therapy
DRUG
Docetaxel
DRUG
Lead Sponsor
Gynecologic Oncology Group
Collaborators
NCT04550494
NCT07144826
Data Source & Attribution
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