Radiation Therapy to the Abdomen Plus Docetaxel in Treating Patients With Recurrent or Persistent Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Docetaxel

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