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A Phase II Trial of MGI 114 in Patients With Advanced Pancreatic Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

A Phase II Trial of MGI 114 in Patients With Advanced Pancreatic Adenocarcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Eric K. Rowinsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

San Antonio Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066884

NCT ID:

NCT00003760

Start Date:

November 1998

Completion Date:

May 2000

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
San Antonio Cancer InstituteSan Antonio, Texas  78229-3264