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

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

Detailed Description
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OBJECTIVES: Determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with CT-2103. Determine the tolerability and safety of the previously established dose and schedule of CT-2103 in these patients. OUTLINE: This is a dose-escalation study. Patients receive CT-2103 IV over 10 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. If no more than 1 of the first 6 patients experience dose-limiting toxicity, then the remaining patients receive a higher dose of CT-2103. Patients are followed between 1-3 months and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Official Title
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A Phase I/II Trial fo Intravenous CT-2103 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: paclitaxel poliglumex


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma Recurrent disease following prior initial therapy with platinum-based regimen No more than 2 prior cytotoxic chemotherapy regimens for recurrent disease No more than 1 prior non-platinum, non-taxane regimen At least 1 site of radiographically measurable disease AND/OR CA-125 levels at least 50% above upper limits of normal for a minimum of 2 samples PATIENT CHARACTERISTICS: Age Not specified Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT less than 1.5 times ULN Alkaline phosphatase less than 1.5 times ULN Renal Creatinine no greater than 1.5 mg/dL Other No unresolved, pre-existing grade 2 or greater neurotoxicity from prior treatment with neurotoxic drugs No active uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy At least 4 weeks since prior immunotherapy and recovered Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered Endocrine therapy At least 4 weeks since prior endocrine therapy and recovered Radiotherapy At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered Surgery Not specified Other At least 4 weeks since other prior investigational drugs and recovered
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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paclitaxel poliglumex|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer