CT-2103 in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

PRIMARY OBJECTIVES:

I. Determine the antitumor activity of polyglutamate paclitaxel (CT-2103) as third-line
treatment for patients with recurrent or persistent ovarian epithelial or primary peritoneal
cancer.

II. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive polyglutamate paclitaxel (CT-2103) IV over 10-20 minutes on day 1. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

Inclusion Criteria:

- Histologically confirmed recurrent or persistent ovarian epithelial cancer or primary
peritoneal cancer after second-line therapy

- Received 1 prior platinum-based first-line chemotherapy regimen and 1 prior
second-line (non-platinum, non-taxane) chemotherapy regimen

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- At least 1 target lesion that has not previously been irradiated

- Ineligible for a higher priority GOG protocol (if one exists)

- Ineligible for the currently active phase II cytotoxic protocol for platinum-resistant
disease

- Performance status - GOG 0-2

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- No active bleeding

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2.5 times ULN

- Alkaline phosphatase no greater than 2.5 times ULN

- PT or PTT less than ULN

- Creatinine no greater than 1.5 times ULN

- No uncontrolled hypertension

- No uncompensated congestive heart failure

- No symptomatic coronary artery disease

- No myocardial infarction within the past 6 months

- No sensory or motor neuropathy greater than grade 1

- No active infection requiring antibiotics

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- At least 3 weeks since prior biological therapy or immunotherapy directed at the
malignancy

- No prior polyglutamate paclitaxel (CT-2103)

- Recovered from prior chemotherapy

- At least 1 week since prior hormonal therapy directed at the malignancy

- Concurrent hormone replacement therapy allowed

- Recovered from prior radiotherapy

- No prior radiotherapy to more than 25% of bone marrow

- Recovered from prior surgery

- At least 3 weeks since other prior therapy directed at the malignancy

- No prior therapy for another malignancy that would preclude this study

- No concurrent amifostine or other protective reagents