NCT00017056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2001

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

11 months

First QC Date

June 6, 2001

Last Update Submit

June 17, 2013

Conditions

Esophageal CancerGastric Cancer

Keywords

stage IV gastric cancerrecurrent gastric cancerstage IV esophageal cancerrecurrent esophageal canceradenocarcinoma of the stomachadenocarcinoma of the esophagus

Interventions

ixabepiloneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma Of Esophagus

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Manish A. Shah, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2001

First Posted

February 16, 2004

Study Start

February 1, 2001

Primary Completion

January 1, 2002

Study Completion

January 1, 2002

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

US(1)