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
1 other identifier
interventional
N/A
1 country
16
Brief Summary
The purpose of this clinical research study is to learn if BMS-247550 can shrink or slow the growth of the cancer in patients with non-small cell lung cancer who have failed first-line platinum based chemotherapy. The safety of this treatment will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2001
Typical duration for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 3, 2002
CompletedFirst Posted
Study publicly available on registry
May 6, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2004
CompletedFebruary 10, 2016
February 1, 2016
3.2 years
May 3, 2002
February 9, 2016
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed non-small cell lung cancer
- 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.
You may not qualify if:
- More than one prior chemotherapy regimen for Stage IIIB or IV or for metastatic recurrent disease. Prior adjuvant or neoadjuvant chemotherapy is allowed.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Pharmlead
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Un of California Davis Cancer Center
Sacramento, California, 958177, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
H Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Rush Presbyterian St Lukes ME
Chicago, Illinois, 60612-3828, United States
Consultants in Blood Disorders
Louisville, Kentucky, 40207, United States
Ochsner Cancer Institute
New Orleans, Louisiana, 70121, United States
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, 21201, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
University of Missouri/Ellis Fischel Cancer Center
Columbia, Missouri, 65203, United States
Dartmouth-Hitchcock /Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Unviversity of North Carolina
Chapel Hill, North Carolina, 27599, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Vanderbilt University Med School Div of Medical Oncology
Nashville, Tennessee, 37232-5536, United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792, United States
Related Publications (1)
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.
PMID: 17606973BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 3, 2002
First Posted
May 6, 2002
Study Start
February 1, 2001
Primary Completion
April 1, 2004
Study Completion
April 1, 2004
Last Updated
February 10, 2016
Record last verified: 2016-02