Irofulvene In Treating Patients With Stage III Or Stage IV Pancreatic Cancer

Study Overview

Irofulvene in Treating Patients With Stage III or Stage IV 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 irofulven in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed.

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. 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.

Pancreatic Cancer

DRUG: irofulven

CDR0000066884
P30CA054174 (U.S. NIH Grant/Contract)
UTHSC-9895011082 (OTHER Identifier) (OTHER: UTHSCSA IRB)
MGI-114.27.P98-03 (OTHER Identifier) (OTHER: Merck)
SACI-IDD-98-18 (OTHER Identifier) (OTHER: San Antonio Cancer Institute)
NCI-V99-1517 (OTHER Identifier) (OTHER: NCI)

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 1999-11-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-08-07
First Submitted that Met QC Criteria 2004-08-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-08-09
First Posted (ESTIMATED) 2004-08-04	Results First Posted N/A	Last Verified 2012-08

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:
Na

Interventional Model:
Single Group

Masking:
None

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:

Collaborators and Investigators

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

National Cancer Institute (NCI)
University of Texas
Merck Sharp & Dohme LLC

Investigators

STUDY_CHAIR: Eric K. Rowinsky, MD, San Antonio Cancer Institute

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

No publications available

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Clinical Trial Record