Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Pharmaceutical / Industry UTHSC-9895011082 MGI-114.27.P98-03, SACI-IDD-98-18, NCI-V99-1517

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.

Entry 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

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

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

Projected Accrual

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

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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

San Antonio Cancer Institute

Eric Rowinsky, MD, Protocol chair		Ph: 210-616-5798 Email: erowinsk@idd.org

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