BMS-247550 In Treating Patients With Advanced Pancreatic Cancer

Study Overview

BMS-247550 in Treating Patients With Advanced Pancreatic Cancer

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 advanced pancreatic cancer.

OBJECTIVES: * Determine the 6-month survival rate and time to treatment failure in patients with advanced pancreatic adenocarcinoma treated with BMS-247550. * Determine the frequency and severity of toxic effects of this drug in these patients. * Determine the complete and partial response in those patients with measurable disease treated with this drug. * Determine the pharmacokinetic profile of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 6 months for 2 years and then annually until 3 years after registration. PROJECTED ACCRUAL: A total of 25-55 patients will be accrued for this study.

Pancreatic Cancer

DRUG: ixabepilone

CDR0000068636
SWOG-S0107

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-06-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-20
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-24
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2003-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed advanced pancreatic adenocarcinoma

Distant metastases OR
Locoregional disease that has failed or is not amenable to locoregional therapy
No de novo locoregional disease
No known brain metastases

Adult

Zubrod 0-1

Not specified

Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
SGOT or SGPT no greater than 2.5 times ULN
Alkaline phosphatase less than 2.5 times ULN

Creatinine no greater than 1.5 mg/dL

No recent myocardial infarction, unstable angina, or life-threatening arrhythmia

Not pregnant or nursing
Fertile patients must use effective contraception
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in remission
No prior severe hypersensitivity reaction to drugs containing Cremophor EL
No active or uncontrolled infection
No severe psychiatric disorders

No prior neoadjuvant, adjuvant, or primary immunotherapy for advanced pancreatic cancer
No concurrent anticancer immunotherapy

No prior neoadjuvant, adjuvant, or primary chemotherapy for advanced pancreatic cancer
No other concurrent anticancer chemotherapy

No prior neoadjuvant, adjuvant, or primary hormonal therapy for advanced pancreatic cancer
No concurrent anticancer hormonal therapy

No prior neoadjuvant, adjuvant, or primary radiotherapy or chemoradiotherapy for advanced pancreatic cancer
Prior palliative radiotherapy allowed if at least 1 lesion remains outside of radiation field or at least 1 lesion has progressed since radiotherapy
No concurrent anticancer radiotherapy except palliative radiotherapy to non-target metastatic sites

At least 2 weeks since prior surgery for pancreatic cancer and recovered

No other concurrent anticancer therapy
No concurrent herbal or unconventional therapy (e.g., St. John's Wort)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Robert P. Whitehead, MD, University of Texas

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Whitehead RP, McCoy S, Rivkin SE, Gross HM, Conrad ME, Doolittle GC, Wolff RA, Goodwin JW, Dakhil SR, Abbruzzese JL. A Phase II trial of epothilone B analogue BMS-247550 (NSC #710428) ixabepilone, in patients with advanced pancreas cancer: a Southwest Oncology Group study. Invest New Drugs. 2006 Nov;24(6):515-20. doi: 10.1007/s10637-006-8440-x.

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Clinical Trial Record