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BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been 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
Memorial Sloan Kettering Cancer Center
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 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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
June 17, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017056
Brief Title
BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been 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 Fluoropyrimidine And/Or Platinum
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
January 2002 (Actual)
Study Completion Date
January 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
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 recurrent metastatic stomach cancer that has been previously treated with chemotherapy.
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.

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 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
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

Learn more about this trial

BMS-247550 in Treating Patients With Recurrent Metastatic Stomach Cancer That Has Been Previously Treated With Chemotherapy

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