A Phase I Study Using Low Dose Abdominal Radiotherapy as A Docetaxel Chemosensitizer for Recurrent , Persistent Or Advanced Ovarian, Peritoneal Or Fallopian Tube Cancer
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Gynecologic Oncology Group
- Enrollment
- 13
- Locations
- 7
- Primary Endpoint
- Incidence of acute toxicity, graded using Common Toxicity Criteria version 2.0
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (chemosensitization, radiation, 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.
Intervention: 3-Dimensional Conformal Radiation Therapy (Radiation)
Treatment (chemosensitization, radiation, 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.
Intervention: Chemosensitization/Potentiation Therapy (Drug)
Treatment (chemosensitization, radiation, 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.
Intervention: Docetaxel (Drug)
Outcomes
Primary Outcomes
Incidence of acute toxicity, graded using Common Toxicity Criteria version 2.0
Time Frame: Up to 30 days after completion of radiation therapy
Secondary Outcomes
- 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(Up to 5 years)