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

Completed · Phase 1

Conditions studied: Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma, Stage III Ovarian Cancer, Stage IV Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00066456

Run by

Gynecologic Oncology Group

People needed

13

Starts

2003-09-01

Last updated by the study team

2016-02-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
• University of Iowa/Holden Comprehensive Cancer Center — Iowa City, Iowa, United States
• University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Lake University Ireland Cancer Center — Mentor, Ohio, United States
• Cancer Care Associates-Midtown — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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