A Phase I Study Using Low Dose Abdominal Radiotherapy As A Docetaxel Chemosensitizer For Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer
- 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
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 0.25-2.5
Primary Purpose: Treatment
Dose-limiting toxicity at 1 year
Paula M. Fracasso, MD, PhD
Washington University Siteman Cancer Center
United States: Federal Government
|Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Cancer Care Associates - Saint Francis Campus||Tulsa, Oklahoma 74136-1929|