Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT00030706|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 28, 2018
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Peritoneal Cavity Cancer||Drug: ixabepilone||Phase 2|
- Determine the antitumor activity of ixabepilone, in terms of clinical response and progression-free survival, in patients with relapsed and/or refractory stage III or IV ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this drug in these patients.
- Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian cancer cells with quality of response (i.e., at least partial response vs no response).
- Correlate CYP3A4 (3A4*1B), 3A5 (3A5*1), and 3A7 (ER6 p variation) allelic polymorphisms with parent drug kinetic parameters, toxicity, and efficacy of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive ixabepilone IV over 1 hour once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Of Epothilone B Analogue BMS-247550 In Relapse And/Or Refractory Stage III Or IV Ovarian Epithelial Cancer, Following Front-Line Treatment With Platinum Plus Taxane-Based Chemotherapy|
|Actual Study Start Date :||November 2004|
|Actual Primary Completion Date :||February 2007|
- Incidence of clinical remission [ Time Frame: up to 12-months post-treatment ]number of participants experience clinical remission will be determined
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030706
|United States, New York|
|Albert Einstein Cancer Center at Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Gary L. Goldberg, MD||Albert Einstein College of Medicine|