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A Phase II Trial of BBR 3464 as First Line Treatment in Patients With Inoperable, Locally Advanced or Metastatic Adenocarcinoma of the Pancreas

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

Thank you

Trial Information

A Phase II Trial of BBR 3464 as First Line Treatment in Patients With Inoperable, Locally Advanced or Metastatic Adenocarcinoma of the Pancreas

OBJECTIVES: I. Determine the overall survival of patients with inoperable locally advanced
or metastatic adenocarcinoma of the pancreas treated with BBR 3464. II. Determine the
response rate, duration of response, time to disease progression, and duration of stable
disease in patients treated with this drug. III. Determine the incidence and severity of the
toxic effects of this drug in these patients. IV. Determine the disease-related symptoms in
patients treated with this drug.

OUTLINE: This is a multicenter study. Patients receive BBR 3464 IV over 1 hour on day 1.
Treatment repeats every 21 days for a minimum of 6 courses in the absence of disease
progression or unacceptable toxicity. Patients are followed every 9 weeks.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the
pancreas Inoperable locally advanced or metastatic disease Previously untreated disease At
least 1 measurable lesion Lesions in a previously irradiated field are not considered
measurable Brain metastases allowed provided symptoms are stable and patient is receiving
a stable dose of steroids within 1 month prior to study

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not
specified Hematopoietic: 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 times upper
limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN ALT or AST no
greater than 2 times ULN (5 times ULN if liver metastases present) Renal: Creatinine no
greater than 1.5 mg/dL OR Creatinine clearance at least 40 mL/min Cardiovascular: No
congestive heart failure No angina pectoris (even if medically controlled) No myocardial
infarction within the past year No uncontrolled hypertension No arrhythmia Neurologic: No
significant neurological disorder except that caused by metastatic disease or psychiatric
disorders No clinically significant abnormal findings on audiogram or neurological
examination Other: No other serious illness or medical condition No uncontrolled
concurrent infection No prior disposition to diarrhea (e.g., Crohn's disease or ulcerative
colitis) No poor nutritional status that would be compromised by severe diarrhea No other
prior or concurrent malignancy except: Curatively treated nonmelanoma skin cancer or
carcinoma in situ of the cervix OR Other cancer curatively treated by surgery alone that
has not recurred for more than 5 years No other condition that would preclude study Not
pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception during and for at least 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent antitumor
immunotherapy Chemotherapy: No prior chemotherapy No other concurrent antitumor
chemotherapy Endocrine therapy: See Disease Characteristics No prior endocrine therapy No
concurrent antitumor hormonal therapy Radiotherapy: See Disease Characteristics Prior
single fraction of radiotherapy for palliation allowed No concurrent radiotherapy except
for local palliation to a nontarget lesion Surgery: See Disease Characteristics Prior
surgeries allowed At least 4 weeks since prior major thoracic and/or abdominal surgery (2
weeks for biliary drainage procedures) and recovered Other: At least 30 days since prior
investigational drugs No other concurrent investigational drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

George L. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma Oncology, Incorporated at LaFortune Cancer Center


United States: Federal Government

Study ID:




Start Date:

May 2001

Completion Date:

Related Keywords:

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



Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
Massey Cancer Center Richmond, Virginia  23298-0037
Oklahoma Oncology Inc. Tulsa, Oklahoma  74104
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group Memphis, Tennessee  38119
Arizona Oncology Associates Tucson, Arizona  85712-2254