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

About this trial
This is an interventional treatment trial for Primary Peritoneal Carcinoma
Eligibility Criteria
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
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (polyglutamate paclitaxel)
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.