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

Gastric Cancer Clinical Trial

Official title:

A Phase II Study of Epothilone Analog BMS-247550 in Patients With Metastatic Gastric Adenocarcinoma Previously Treated With a Taxane

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00017043
• Other study ID #: CDR0000068644
• Secondary ID: BMS-MSKCC-01011M
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2001
• Last updated: April 3, 2013
• Start date: February 2001
• Est. completion date: January 2003

Study information

• Verified date: April 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• ixabepilone

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,