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BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery Clinical research trials and BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery. BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery clinical trial. Participants oftentimes recieve the most expert healthcare available for their BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery  BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery
BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery
For Condition: stage 3 pancreatic cancer,stage 4A pancreatic cancer,adenocarcinoma of the pancreas,stage 4B pancreatic cancer
Status: No longer recruiting
Sponsor(s): Theradex ,
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeMiller, Study Chair, Theradex
Arizona Oncology Associates
Tucson, Arizona, 85712-2254
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Oklahoma Oncology Inc.
Tulsa, Oklahoma, 74104
United States
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group
Memphis, Tennessee, 38119
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Additional Information:
Study ID Numbers: CDR0000068924; NOVUSPHARMA-TPT-II-06,THERADEX-TPT-II-06
Study Start Date: May 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024362
Other Stage 4a Pancreatic Cancer Studies:
1. Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
2. Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
3. Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
4. Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer
5. BMS-247550 in Treating Patients With Advanced Pancreatic Cancer
Related Studies:
Other stage 4A pancreatic cancer Clinical Trials
Other Illinois Clinical Trials
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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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