BMS-247550 in Treating Patients With Advanced Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00016965
First received: June 6, 2001
Last updated: June 20, 2013
Last verified: April 2003
  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 2

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

Resource links provided by NLM:


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

Study Start Date: July 2001
Study Completion Date: April 2006
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
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Robert P. Whitehead, MD University of Texas
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00016965     History of Changes
Other Study ID Numbers: CDR0000068636, SWOG-S0107
Study First Received: June 6, 2001
Last Updated: June 20, 2013
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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014