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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024362
First received: September 13, 2001
Last updated: July 23, 2008
Last verified: April 2007
  Purpose

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 Intervention Phase
Pancreatic Cancer
Drug: BBR 3464
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024362

Locations
United States, Arizona
Arizona Oncology Associates
Tucson, Arizona, United States, 85712-2254
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Oklahoma
Oklahoma Oncology Inc.
Tulsa, Oklahoma, United States, 74104
United States, Tennessee
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
Memphis, Tennessee, United States, 38119
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Sponsors and Collaborators
Theradex
Investigators
Study Chair: George L. Miller, MD Oklahoma Oncology, Incorporated at LaFortune Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00024362     History of Changes
Other Study ID Numbers: CDR0000068924, THERADEX-TPT-II-06, NOVUSPHARMA-TPT-II-06
Study First Received: September 13, 2001
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
BBR 3464
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014