Brief Title
Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer
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
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence of acute toxicity, graded using Common Toxicity Criteria version 2.0
Secondary Outcome
Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria version 2.0 Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (CTC v2.0 RTOG/EORTC) late radiation morbidity scoring
Condition
Fallopian Tube Carcinoma
Intervention
3-Dimensional Conformal Radiation Therapy
Study Arms / Comparison Groups
Treatment (chemosensitization, radiation, docetaxel)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
13
Start Date
September 2003
Primary Completion Date
July 2010
Eligibility Criteria
Inclusion Criteria:
- 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
- Performance status - GOG 0-1
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- 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
- Creatinine no greater than 1.5 times ULN
- 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
- No prior radiotherapy to the abdomen or pelvis
- Patients with ureteral obstruction must undergo stent or nephrostomy tube replacement
prior to study entry
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Paula Fracasso, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00066456
Organization ID
GOG-9915
Secondary IDs
NCI-2009-00618
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Paula Fracasso, Principal Investigator, Gynecologic Oncology Group
Verification Date
February 2016