A Phase I Study Using Low Dose Abdominal Radiotherapy As A Docetaxel Chemosensitizer For Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer
18 Years
N/A
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
A Phase I Study Using Low Dose Abdominal Radiotherapy As A Docetaxel Chemosensitizer For Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of ovarian, peritoneal, or fallopian tube carcinoma
- Radiographic, clinical, or pathologic evidence of relapse
- Recurrent or persistent disease after chemotherapy (may be enrolled at first or
subsequent relapse)
- Received prior taxane OR platinum agent
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- 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 upper limit of normal (ULN)
- SGOT/SGPT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No grade 2 or greater neuropathy (sensory or motor)
- No septicemia
- No severe infection
- No circumstance that would preclude study completion
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the abdomen or pelvis
Surgery
- Patients with ureteral obstruction must undergo stent or nephrostomy tube replacement
prior to study entry
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Dose-limiting toxicity at 1 year
Safety Issue:
Yes
Principal Investigator
Paula M. Fracasso, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Washington University Siteman Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000316238
NCT ID:
NCT00066456
Start Date:
October 2003
Completion Date:
Related Keywords:
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- recurrent ovarian epithelial cancer
- primary peritoneal cavity cancer
- fallopian tube cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| 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 |
