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

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ixabepilone
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: 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 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/mm^3 Platelet count greater than 125,000/mm^3 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 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 PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: 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 Radiotherapy: 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 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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
April 3, 2013
Sponsor
Bristol-Myers Squibb
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017043
Brief Title
BMS-247550 in Treating Patients With Metastatic Stomach Cancer Previously Treated With Chemotherapy
Official Title
A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer
Keywords
stage IV gastric cancer, recurrent gastric cancer, stage IV esophageal cancer, recurrent esophageal cancer, adenocarcinoma of the stomach, adenocarcinoma of the esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ixabepilone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 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/mm^3 Platelet count greater than 125,000/mm^3 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 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 PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: 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 Radiotherapy: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish A. Shah, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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