ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

6-Hydroxymethylacylfulvene in Treating Patients With Stage III or Stage IV Pancreatic Cancer

This study is no longer recruiting patients.

Sponsored by: San Antonio Cancer Institute
Information provided by: National Cancer Institute (NCI)

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 6-hydroxymethylacylfulvene in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed.

Condition Treatment or Intervention Phase
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
adenocarcinoma of the pancreas
 Drug: -hydroxymethylacylfulvene
Phase II

MedlinePlus related topics:  Pancreatic Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of 6-Hydroxymethylacylfulvene (MGI 114) in Patients with Stage III or IV Unresectable Adenocarcinoma of the Pancreas

Further Study Details: 

Study start: October 1998

OBJECTIVES: I. Determine the survival rate at 6 months of patients with stage III or IV unresectable adenocarcinoma of the pancreas treated with 6-hydroxymethylacylfulvene (MGI 114).

II. Determine the objective tumor response rate, time to objective tumor response, and duration of response in these patients (if retrospective data is available, time to tumor progression while on prior gemcitabine is determined).

III. Determine the clinical benefit of MGI 114 as measured by pain improvement, performance status, and weight.

IV. Determine the survival rate at 3, 9, and 12 months in these patients.

V. Gain additional information on the toxic effects and safety profile of this regimen.

PROTOCOL OUTLINE: This is an open label, multicenter study.

Patients receive 6-hydroxymethylacylfulvene (MGI 114) IV over 5 minutes on days 1-5. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for up to 1 year after therapy initiation.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12-18 months.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--


Location Information


Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States

Texas
      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234,  United States

      San Antonio Cancer Institute, San Antonio,  Texas,  78229,  United States

Study chairs or principal investigators

Eric Keith Rowinsky,  Study Chair,  San Antonio Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066884; UTHSC-9895011082; NCI-V99-1517; MGI-114.27.P98-03; SACI-IDD-98-18
Record last reviewed:  August 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003760
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-25
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act