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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
irofulven
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, stage IV pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska Medical Center
  • Brooke Army Medical Center
  • San Antonio Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
August 7, 2012
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Cancer Institute (NCI), University of Texas, Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00003760
Brief Title
Irofulvene in Treating Patients With Stage III or Stage IV Pancreatic Cancer
Official Title
A Phase II Trial of MGI 114 in Patients With Advanced Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 1998 (undefined)
Primary Completion Date
May 2000 (Actual)
Study Completion Date
May 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Cancer Institute (NCI), University of Texas, Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, stage IV pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
irofulven
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric K. Rowinsky, MD
Organizational Affiliation
San Antonio Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3330
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
San Antonio Cancer Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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

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