ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
BMS-247550 in Treating Patients With Advanced Pancreatic Cancer

This study has been completed.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016965
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: ixabepilone
Phase II

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

Drug Information available for:   Epothilone B    Ixabepilone    Pancrelipase    Ultrase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) Every 21 Days in Patients With Advanced Pancreas Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 2001

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Adult

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

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

Endocrine therapy:

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

Radiotherapy:

  • 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

Surgery:

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

Other:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016965

Show 95 study locations  Show 95 Study Locations

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Robert P. Whitehead, MD     University of Texas    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068636, SWOG-S0107
First Received:   June 6, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00016965
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer  
stage III pancreatic cancer  
recurrent pancreatic cancer  
adenocarcinoma of the pancreas  
stage IV pancreatic cancer  

Study placed in the following topic categories:
Epothilone B
Digestive System Neoplasms
Pancreatic Neoplasms
Epothilones
Endocrine System Diseases
Pancrelipase
Recurrence
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers