Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy

Study Overview
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Brief Summary
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Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in 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 ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer. II. Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Official Title
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A Phase II Evaluation of Epothilone-B BMS 247550 (NSC # 710428) in the Treatment of Recurrent or Persistent Platinum and Paclitaxel Refractory Ovarian or Primary Peritoneal Cancer

Conditions
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Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

Intervention / Treatment
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* Drug: ixabepilone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer Recurrent or persistent disease Platinum AND taxane-resistant or refractory disease Progressed during therapy Refractory disease within 6 months of therapy Measurable disease At least 20 mm by conventional techniques At least 10 mm by spiral CT scan Tumor lesions located within a previously irradiated field are not considered measurable disease unless there is documented tumor progression in these lesions or biopsy confirmation ≥ 90 days following completion of radiotherapy Ineligible for higher priority GOG (Gynecologic Oncology Group) protocol No active brain metastases Performance status - GOG 0-2 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT (serum glutamate oxaloacetate transaminase) ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN No sensory or motor neuropathy > grade 1 No dementia or altered mental status No other serious uncontrolled medical disorder No active infection requiring antibiotics No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL No other 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 biologic therapy At least 3 weeks since prior immunotherapy Must have received: 1 prior combination taxane-based and platinum-based chemotherapy regimen 1 prior platinum-based chemotherapy regimen AND 1 prior taxane-based chemotherapy regimen Initial treatment may include high-dose therapy, consolidation, or extended therapy At least 3 weeks since prior chemotherapy and recovered No prior ixabepilone No other prior cytotoxic chemotherapy for recurrent or persistent disease, including treatment with initial regimen At least 1 week since prior hormonal anticancer therapy Concurrent hormone replacement therapy allowed At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to site(s) of measurable disease No radiotherapy to > 25% of marrow-containing areas Recovered from recent surgery At least 3 weeks since other anticancer therapy No prior anticancer therapy that precludes study participation No concurrent food supplements (e.g., St. John's wort) No concurrent amifostine or other protective agents
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 (ixabepilone)<br>Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR. | Drug: ixabepilone<br>* Given IV<br>* Other names: Ixempra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response | Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval. Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation. | Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months. | 
| Number of People With Adverse Effects |  | Every cycle until completion of study treatment up to 30 days after stopping study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression. | From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up | 
| Overall Survival | Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. | From study entry to death or last contact, up to 5 years of follow-up. |