Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
RATIONALE: 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.
PURPOSE: 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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: chemosensitization/potentiation therapy
Radiation: radiation therapy
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study Using Low Dose Abdominal Radiotherapy As A Docetaxel Chemosensitizer For Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer|
- Dose-limiting toxicity at 1 year [ Designated as safety issue: Yes ]
|Study Start Date:||October 2003|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- 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.
- 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.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 0.25-2.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066456
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, Ohio|
|Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Lake/University Ireland Cancer Center|
|Mentor, Ohio, United States, 44060|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|Cancer Care Associates - Saint Francis Campus|
|Tulsa, Oklahoma, United States, 74136-1929|
|Study Chair:||Paula M. Fracasso, MD, PhD||Washington University Siteman Cancer Center|
|Study Chair:||Katherine Y. Look, MD||Indiana University Melvin and Bren Simon Cancer Center|