A Phase 1 interventional study of 3-Dimensional Conformal Radiation Therapy and Chemosensitization/Potentiation Therapy in Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma and Recurrent Ovarian Carcinoma, sponsored by Gynecologic Oncology Group. Completed at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-11.
Sponsored by Gynecologic Oncology Group · Phase 1, Interventional, and Treatment
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.
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.
734 studies on the registry are indexed under Fallopian Tube Neoplasms; 128 are open to participants now.
This study's enrollment of 13 is below the median of 51 across 598 interventional studies indexed under Fallopian Tube Neoplasms.
Browse Fallopian Tube Neoplasms studies →Gynecologic Oncology Group is the lead sponsor of 188 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Recurrent or persistent disease after chemotherapy (may be enrolled at first or subsequent relapse)
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.
Radiation: 3-Dimensional Conformal Radiation Therapy · Drug: Chemosensitization/Potentiation Therapy · Drug: Docetaxel
Also known as: 3-dimensional radiation therapy, 3D CONFORMAL RADIATION THERAPY, 3D CRT, 3D-CRT, Conformal Therapy, Radiation Conformal Therapy
Given IV
Also known as: Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Incidence of acute toxicity, graded using Common Toxicity Criteria version 2.0
Time frame: Up to 30 days after completion of radiation therapy
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
Time frame: Up to 5 years
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Docetaxel