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