BMS-247550 in Treating Patients With Metastatic Stomach Cancer Previously Treated With Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00017043
Recruitment Status : Completed
First Posted : September 9, 2003
Last Update Posted : April 5, 2013
National Cancer Institute (NCI)
Information provided by:
Bristol-Myers Squibb

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have metastatic stomach cancer previously treated with chemotherapy.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: ixabepilone Phase 2

Detailed Description:


  • Determine the clinical activity of BMS-247550, in terms of response rate, in patients with previously treated metastatic gastric adenocarcinoma.
  • Determine the safety of this drug in these patients.
  • Assess the response duration, time to progression, and survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive BMS-247550 IV over 1 hour on day 1. Treatment repeats every 21 days for 2-18 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses after confirmation of CR.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-58 patients will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane
Study Start Date : February 2001
Primary Completion Date : January 2003
Study Completion Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Ixabepilone
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma originating in the stomach or gastroesophageal junction

    • Failed prior taxane-based chemotherapy regimen* in the metastatic setting OR
    • Relapsed within 6 months of completing taxane-based chemotherapy* in the adjuvant setting
  • Bidimensionally measurable metastatic disease

    • No prior radiotherapy to only measurable target lesion
  • No squamous cell or sarcomatous disease
  • No known brain metastases NOTE: *Regimen must have included a fluopyrimidine and/or a platinum drug



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count greater than 125,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT no greater than 2.5 times ULN (5 times ULN if liver metastases present)


  • Creatinine no greater than 2 times ULN


  • No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months


  • No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No serious concurrent infection
  • No nonmalignant uncontrolled medical illness that would preclude study
  • No psychiatric disorder or other condition that would preclude study compliance
  • No neuropathy (neuromotor or neurosensory) of grade 2 or greater
  • No known severe hypersensitivity to agents containing Cremophor EL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after the study


Biologic therapy:

  • No concurrent immunotherapy


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy for metastatic disease
  • Prior neoadjuvant and adjuvant chemotherapy allowed
  • No more than 1 prior chemotherapy regimen for metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except hormone replacement therapy


  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to major bone marrow-containing areas (e.g., pelvis or lumbar spine)
  • No concurrent therapeutic radiotherapy


  • At least 1 week since prior minor surgery and recovered
  • At least 3 weeks since prior major surgery and recovered


  • No other concurrent experimental anticancer medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00017043

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Bristol-Myers Squibb
National Cancer Institute (NCI)
Study Chair: Manish A. Shah, MD Memorial Sloan Kettering Cancer Center Identifier: NCT00017043     History of Changes
Other Study ID Numbers: CDR0000068644
First Posted: September 9, 2003    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013

Keywords provided by Bristol-Myers Squibb:
stage IV gastric cancer
recurrent gastric cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus

Additional relevant MeSH terms:
Stomach Neoplasms
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases