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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 Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like 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. 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 Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a 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 clinical trial. Subjects frequently get the best healthcare possible for their 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 condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: Carcinoma, Non-Small-Cell Lung
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - 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. Exclusion Criteria - 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
Total Enrollment:
Location and Contact Information:
Ochsner Cancer Institute
New Orleans, Louisiana, 70121
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
United States
Rush Presbyterian St Lukes ME
Chicago, Illinois, 60612-3828
United States
Mount Sinai Medical Center
Miami, Florida, 33140
United States
Lahey Clinic
Burlington, Massachusetts, 01805
United States
Dartmouth-Hitchcock /Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, 21201
United States
H Lee Moffitt Cancer Center
Tampa, Florida, 33612
United States
Vanderbilt University Med School Div of Medical Oncology
Nashville, Tennessee, 37232-5536
United States
University of Missouri/Ellis Fischel Cancer Center
Columbia, Missouri, 65203
United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792
United States
Unviversity of North Carolina
Chapel Hill, North Carolina, 27599
United States
Consultants in Blood Disorders
Louisville, Kentucky, 40207
United States
Un of California Davis Cancer Center
Sacramento, California, 958177
United States
Additional Information:
Study ID Numbers: CA163-011;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00035516
Other Carcinoma, Non-Small-Cell Lung Studies:
1. Vaccine Treatment for Advanced Non-Small Cell Lung Cancer
2. Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent with Metastatic Lung Cancer
3. Phase 1-2a Dose-Ranging Study of TLK286 in Combination with Docetaxel in Platinum-Resistant Non-Small Cell Lung Cancer
4. Study of Cetuximab in Combination with Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer
5. Study of Neurologic Progression with Motexafin Gadolinium and Radiation Therapy (SMART)
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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
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