- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00025155
Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Gynecologic Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment (ixabepilone)
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.
|
Given IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor Response
Time Frame: Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.
|
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.
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Number of People With Adverse Effects
Time Frame: Every cycle until completion of study treatment up to 30 days after stopping study treatment
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Every cycle until completion of study treatment up to 30 days after stopping study treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From study entry to death or last contact, up to 5 years of follow-up.
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Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
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From study entry to death or last contact, up to 5 years of follow-up.
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Progression Free Survival
Time Frame: 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
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David R. Spriggs, Gynecologic Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Epothilones
- Epothilone B
Other Study ID Numbers
- NCI-2012-02413 (REGISTRY: CTRP (Clinical Trial Reporting Program))
- U10CA027469 (U.S. NIH Grant/Contract)
- CDR0000068927
- GOG-0126M (OTHER: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Peritoneal Cavity Cancer
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage... and other conditions
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Roswell Park Cancer InstituteNational Cancer Institute (NCI); Sanofi Pasteur, a Sanofi CompanyCompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIA Fallopian Tube Cancer | Stage IIB Fallopian Tube Cancer | Stage IIC Fallopian Tube Cancer | Stage... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIIA Primary... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity Cancer | Recurrent Fallopian Tube Cancer | Stage IIIA Fallopian Tube Cancer | Stage IIIB Fallopian Tube Cancer | Stage IIIC Fallopian Tube Cancer and other conditionsCanada
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Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedPrimary Peritoneal Cavity Cancer | Carcinoma of the AppendixUnited States
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National Cancer Institute (NCI)CompletedStage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Recurrent Primary Peritoneal Cavity Cancer | Stage IV Primary Peritoneal Cavity CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedOvarian Cancer | Primary Peritoneal Cavity CancerUnited States, Canada
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Merck Sharp & Dohme LLCTerminatedOvarian Cancer | Primary Peritoneal Cavity Cancer
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Gynecologic Oncology GroupNational Cancer Institute (NCI)TerminatedOvarian Cancer | Primary Peritoneal Cavity CancerUnited States, Canada
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