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

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL 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

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   

Study ID Numbers:  CDR0000066884; UTHSC-9895011082; NCI-V99-1517; MGI-114.27.P98-03; SACI-IDD-98-18
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003760
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08