A Phase II Study of Epothilone Analog BMS-247550 in Patients With Non-Small Cell Lung Cancer Who Have Failed First Line Platinum Based Chemotherapy
NCT ID: NCT00035516
Last Updated: 2016-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-02-28
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Epothilone
Eligibility Criteria
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Inclusion Criteria
* Bidimensionally measurable disease
* Progressed following therapy with one prior cisplatin or carboplatin based chemotherapy regimen for Stage III or IV or metastatic recurrent disease
* Adequate hematologic function as defined by: absolute neutrophils =/\> 2,000/mm3, and platelets \> 125,000/mm3
* Adequate hepatic function as defined by: serum bilirubin=/\<1.5 times the upper institutional limits of normal, ALT =/\< 2.5 times the upper institutional limits of normal (=/\<5 times the upper institutional limits of normal if hepatic metastases are present
* Adequate renal function as defined: by serum creatine =/\< 1.5 times the upper limits of normal
* Adequate recovery from recent surgery, chemotherapy and radiation therapy. At least one week must have elapsed from the time of a minor surgery, at least 3 weeks for major surgery, chemotherapy and radiation therapy
* Life expectancy of at least 12 weeks
* ECOG performance status of 0-1
* At least 18 years old
* Willing and able to give written informed consent
* Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center
* Women of Child Bearing Potential (WOCP) must have a negative serum or urine pregnancy test (minimum sensitivity IU/L or equivalent units of HCG) within 72 hours prior to start of study medication.
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal \[defined as amenorrhea=/\>12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level \> 35mIU/mL\]. Even women who are using oral, implanted or, injectable intrauterine device or barrier methods (diaphragm, condoms, spermicide) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential.
Exclusion Criteria
* Patients who are candidates for curative resection.
* CTC Grade 2 or greater neuropathy (motor or sensory)
* Known brain metastases
* Prior radiation must have not included major bone marrow containing areas (pelvis, lumbar, spine) and must not have contained a target lesion as the only measurable lesion. A recovery period of at least 3 weeks after completion of radiotherapy is required prior to enrollment.
* Myocardial infarction, unstable angina, or any history of congestive heart failure within six months of study therapy
* Pregnant or breast-feeding women, or sexually active women of childbearing potential not using an adequate method of birth control.
* Sexually active fertile men, whose partners are women of childbearing potential, unless using an adequate method of birth control
* Serious intercurrent infections, or nonmalignant medical illnesses that are controlled or whose control may be jeopardized by the complications of this therapy
* Psychiatric disorders or other conditions rendering the patient incapable of complying with the requirements of the the protocol
18 Years
ALL
No
Sponsors
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R-Pharm
INDUSTRY
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Un of California Davis Cancer Center
Sacramento, California, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
H Lee Moffitt Cancer Center
Tampa, Florida, United States
Rush Presbyterian St Lukes ME
Chicago, Illinois, United States
Consultants in Blood Disorders
Louisville, Kentucky, United States
Ochsner Cancer Institute
New Orleans, Louisiana, United States
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States
Lahey Clinic
Burlington, Massachusetts, United States
University of Missouri/Ellis Fischel Cancer Center
Columbia, Missouri, United States
Dartmouth-Hitchcock /Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Unviversity of North Carolina
Chapel Hill, North Carolina, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Vanderbilt University Med School Div of Medical Oncology
Nashville, Tennessee, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
Countries
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References
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Vansteenkiste J, Lara PN Jr, Le Chevalier T, Breton JL, Bonomi P, Sandler AB, Socinski MA, Delbaldo C, McHenry B, Lebwohl D, Peck R, Edelman MJ. Phase II clinical trial of the epothilone B analog, ixabepilone, in patients with non small-cell lung cancer whose tumors have failed first-line platinum-based chemotherapy. J Clin Oncol. 2007 Aug 10;25(23):3448-55. doi: 10.1200/JCO.2006.09.7097. Epub 2007 Jul 2.
Other Identifiers
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CA163-011
Identifier Type: -
Identifier Source: org_study_id
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