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BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BBR 3464
Sponsored by
Theradex
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Oncology Associates
  • Alta Bates Comprehensive Cancer Center
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Albert B. Chandler Medical Center, University of Kentucky
  • Beth Israel Deaconess Medical Center
  • Oklahoma Oncology Inc.
  • Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
  • Cancer Center at the University of Virginia
  • Massey Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
July 23, 2008
Sponsor
Theradex
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1. Study Identification

Unique Protocol Identification Number
NCT00024362
Brief Title
BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery
Official Title
A Phase II Trial of BBR 3464 as First Line Treatment in Patients With Inoperable, Locally Advanced or Metastatic Adenocarcinoma of the Pancreas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Theradex

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BBR 3464

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George L. Miller, MD
Organizational Affiliation
Oklahoma Oncology, Incorporated at LaFortune Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712-2254
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Albert B. Chandler Medical Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Oklahoma Oncology Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Cancer Center at the University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States

12. IPD Sharing Statement

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BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery

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