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Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

Primary Purpose

Ovarian Cancer, Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, peritoneal cavity cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma Recurrent or refractory disease Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment Bidimensionally measurable disease by physical exam, CT scan, or MRI Ascites and pleural effusions are not measurable disease No prior irradiation to indicator lesions PATIENT CHARACTERISTICS: Age 18 to 75 Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No prior bleeding disorder or unexplained bleeding Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal Creatinine no greater than 1.5 times ULN Other No active infection requiring antibiotics No grade 2 or greater neuropathy (sensory and motor) No other malignancy within the past 5 years except nonmelanoma skin cancer No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel No other medical condition that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior ixabepilone No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma Endocrine therapy At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma Concurrent hormonal replacement therapy allowed Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to a site of measurable disease used on study No prior radiotherapy to more than 25% of bone marrow Surgery See Disease Characteristics Recovered from prior surgery Other At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma No prior cancer treatment for other invasive malignancies that would preclude study participation No concurrent heparin or other anticoagulants No concurrent Hypericum perforatum (St. John's wort) or any product containing this compound

Sites / Locations

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

Outcomes

Primary Outcome Measures

Incidence of clinical remission
number of participants experience clinical remission will be determined

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
September 27, 2018
Sponsor
Montefiore Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00030706
Brief Title
Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2004 (Actual)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Primary 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. Secondary 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Cavity Cancer
Keywords
stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ixabepilone
Primary Outcome Measure Information:
Title
Incidence of clinical remission
Description
number of participants experience clinical remission will be determined
Time Frame
up to 12-months post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma Recurrent or refractory disease Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment Bidimensionally measurable disease by physical exam, CT scan, or MRI Ascites and pleural effusions are not measurable disease No prior irradiation to indicator lesions PATIENT CHARACTERISTICS: Age 18 to 75 Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No prior bleeding disorder or unexplained bleeding Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal Creatinine no greater than 1.5 times ULN Other No active infection requiring antibiotics No grade 2 or greater neuropathy (sensory and motor) No other malignancy within the past 5 years except nonmelanoma skin cancer No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel No other medical condition that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior ixabepilone No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma Endocrine therapy At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma Concurrent hormonal replacement therapy allowed Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to a site of measurable disease used on study No prior radiotherapy to more than 25% of bone marrow Surgery See Disease Characteristics Recovered from prior surgery Other At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma No prior cancer treatment for other invasive malignancies that would preclude study participation No concurrent heparin or other anticoagulants No concurrent Hypericum perforatum (St. John's wort) or any product containing this compound
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary L. Goldberg, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein Cancer Center at Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

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