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

Study Overview
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Brief Summary
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Phase II trial to study the effectiveness of CT-2103 in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Description
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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.

Official Title
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A Phase II Evaluation of CT-2103 in the Third-Line Treatment of Recurrent or Persistent Epithelial Ovarian or Primary Peritoneal Cancer

Conditions
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Primary Peritoneal Carcinoma, Recurrent Ovarian Carcinoma

Intervention / Treatment
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* Drug: Paclitaxel Poliglumex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (polyglutamate paclitaxel)<br>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. | Drug: Paclitaxel Poliglumex<br>* Given IV<br>* Other names: Xyotax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and duration of objective response |  | 5 years | 
| Frequency and severity of observed adverse effects |  | 5 years | 
| Survival time |  | 5 years | 
| Duration of progression-free interval |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in objective response |  | Baseline to 5 years | 
| Change in observed adverse effects |  | Baseline to 5 years |