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

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.

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-small-cell Lung
• Intervention / Treatment: Drug: Epothilone

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: R-Pharm

Publications and helpful links

General Publications

• 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. Erratum In: J Clin Oncol. 2007 Nov 20;25(33):5339. Edelman, Mark [corrected to Edelman, Martin J].

Study record dates

Study Major Dates

• Study Start: February 1, 2001
• Primary Completion (Actual): April 1, 2004
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: May 3, 2002
• First Submitted That Met QC Criteria: May 3, 2002
• First Posted (Estimate): May 6, 2002

Study Record Updates

• Last Update Posted (Estimate): February 10, 2016
• Last Update Submitted That Met QC Criteria: February 9, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Epothilones
• Other Study ID Numbers: CA163-011