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 BBR 3464 in treating patients who have locally advanced or metastatic pancreatic cancer that cannot be treated with surgery.

Condition	Treatment or Intervention	Phase
stage IVA pancreatic cancer stage III pancreatic cancer stage IVB pancreatic cancer adenocarcinoma of the pancreas	Procedure: chemotherapy  Drug: BBR 3464	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Arizona
      Arizona Oncology Associates, Tucson,  Arizona,  85712-2254,  United States
California
      Alta Bates Comprehensive Cancer Center, Berkeley,  California,  94704,  United States
Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States
Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
Oklahoma
      Oklahoma Oncology Inc., Tulsa,  Oklahoma,  74104,  United States
Tennessee
      Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group, Memphis,  Tennessee,  38119,  United States
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States
      Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States

Study chairs or principal investigators

George Lance Miller,  Study Chair,  Theradex   

Study ID Numbers:  CDR0000068924; THERADEX-TPT-II-06; NOVUSPHARMA-TPT-II-06
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00024362
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08