Irofulvene in Treating Patients With Stage III or Stage IV Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborators:
University of Texas
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00003760
First received: November 1, 1999
Last updated: August 7, 2012
Last verified: August 2012
  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 irofulven in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed.


Condition Intervention Phase
Pancreatic Cancer
Drug: irofulven
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of MGI 114 in Patients With Advanced Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Enrollment: 3
Study Start Date: November 1998
Study Completion Date: May 2000
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: irofulven
    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.
Detailed Description:

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.

  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 stage III or IV unresectable adenocarcinoma of the exocrine pancreas Must have been treated with 1 prior gemcitabine regimen, and have documented disease progression either during or within 6 months after completion of therapy Measurable or evaluable disease outside of previously irradiated area No islet cell tumors or lymphoma of the pancreas No significant CNS disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastases) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No atrial or ventricular arrhythmias requiring medication No atrial fibrillation (with or without medication) No ischemic event within past 6 months No history of congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No significant psychiatric disorders No active infection No other prior malignancies within past 5 years, except: Basal or squamous cell skin cancer Carcinoma in situ of the cervix No concurrent serious systemic disorder

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior gemcitabine therapy and recovered No other prior chemotherapy (except fluorouracil as a radiation enhancing agent) No other concurrent chemotherapy Endocrine therapy: No prior hormonal therapy No concurrent hormonal therapy (except contraceptives, hormone replacement, or megestrol acetate) Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 4 weeks since prior investigational agents

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003760

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3330
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
San Antonio Cancer Institute
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
University of Texas
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Eric K. Rowinsky, MD San Antonio Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00003760     History of Changes
Other Study ID Numbers: CDR0000066884, P30CA054174, UTHSC-9895011082, MGI-114.27.P98-03, SACI-IDD-98-18, NCI-V99-1517
Study First Received: November 1, 1999
Last Updated: August 7, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
stage III pancreatic cancer
stage IV pancreatic cancer
recurrent pancreatic cancer
adenocarcinoma of the pancreas

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 September 22, 2014