BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been 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: NCT00017056
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : June 18, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

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 recurrent metastatic stomach cancer that has been previously treated with chemotherapy.

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

Detailed Description:

OBJECTIVES: I. Determine the clinical activity of BMS-247550 in terms of response rate in patients with recurrent metastatic gastric cancer previously treated with a fluoropyrimidine or platinum regimen. II. Determine the safety of this drug in this patient population. III. Determine the duration of response, 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 up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive up to 4 additional courses after CR. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21-58 patients will be accrued for this study within 12 months.

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 Fluoropyrimidine And/Or Platinum
Study Start Date : February 2001
Actual Primary Completion Date : January 2002
Actual Study Completion Date : January 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Ixabepilone

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS: Histologically confirmed recurrent metastatic adenocarcinoma of the stomach or gastroesophageal junction No squamous cell or sarcomatous elements in tumor Previously treated with 1 prior fluoropyrimidine and/or platinum based chemotherapy regimen for metastatic disease OR Recurrent disease within 6 months of completing adjuvant fluoropyrimidine-containing therapy Bidimensionally measurable disease No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count greater than 125,000/mm3 Hepatic: 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) Renal: Creatinine no greater than 2 times ULN Cardiovascular: No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months Other: No grade 2 or greater neuropathy (motor or sensory) No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No serious concurrent infection No other medical illness that would preclude study No psychiatric disorder or other condition that would preclude study No known hypersensitivity to Cremophor EL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy Prior adjuvant or neoadjuvant chemotherapy allowed No more than 1 prior chemotherapy regimen for metastatic disease No prior taxane therapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except hormone replacement therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to major bone marrow-containing areas (pelvis, lumbar spine) or to only site of measurable disease No concurrent therapeutic radiotherapy Surgery: At least 1 week since prior minor surgery and recovered At least 3 weeks since prior major surgery and recovered Other: 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): NCT00017056

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Manish A. Shah, MD Memorial Sloan Kettering Cancer Center Identifier: NCT00017056     History of Changes
Other Study ID Numbers: 01-015
CDR0000068645 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
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