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

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.

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