Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Lexington, Kentucky 40536


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. 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.


Study summary:

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.


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


NCT ID:

NCT00066456


Primary Contact:

Principal Investigator
Paula Fracasso
Gynecologic Oncology Group


Backup Contact:

N/A


Location Contact:

Lexington, Kentucky 40536
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.