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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035516
First received: May 3, 2002
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Carcinoma, Non-small-cell Lung
Drug: Epothilone
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Study Start Date: February 2001
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035516

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Un of California Davis Cancer Center
Sacramento, California, United States, 958177
United States, Florida
Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
Rush Presbyterian St Lukes ME
Chicago, Illinois, United States, 60612-3828
United States, Kentucky
Consultants in Blood Disorders
Louisville, Kentucky, United States, 40207
United States, Louisiana
Ochsner Cancer Institute
New Orleans, Louisiana, United States, 70121
United States, Maryland
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Missouri
University of Missouri/Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
United States, New Hampshire
Dartmouth-Hitchcock /Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, North Carolina
Unviversity of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Tennessee
Vanderbilt University Med School Div of Medical Oncology
Nashville, Tennessee, United States, 37232-5536
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00035516     History of Changes
Other Study ID Numbers: CA163-011
Study First Received: May 3, 2002
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014