BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery
NCT ID: NCT00024362
Last Updated: 2008-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2001-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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BBR 3464
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Theradex
INDUSTRY
Principal Investigators
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George L. Miller, MD
Role: STUDY_CHAIR
Oklahoma Oncology, Incorporated at LaFortune Cancer Center
Locations
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Arizona Oncology Associates
Tucson, Arizona, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Oklahoma Oncology Inc.
Tulsa, Oklahoma, United States
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
Memphis, Tennessee, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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THERADEX-TPT-II-06
Identifier Type: -
Identifier Source: secondary_id
NOVUSPHARMA-TPT-II-06
Identifier Type: -
Identifier Source: secondary_id
CDR0000068924
Identifier Type: -
Identifier Source: org_study_id