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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00024362
• Other study ID #: CDR0000068924
• Secondary ID: THERADEX-TPT-II-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 13, 2001
• Last updated: July 23, 2008
• Start date: May 2001

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• BBR 3464

Locations

Country	Name	City	State
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
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	Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group	Memphis	Tennessee
United States	Massey Cancer Center	Richmond	Virginia
United States	Arizona Oncology Associates	Tucson	Arizona
United States	Oklahoma Oncology Inc.	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Theradex

Country where clinical trial is conducted

United States,