Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
- Conditions
- Pancreatic CancerNeoplasm MetastasisAdenocarcinoma
- Registration Number
- NCT00116389
- Lead Sponsor
- Point Therapeutics
- Brief Summary
The purpose of this study is to assess the 6-month survival rate and safety of talabostat and gemcitabine in patients with stage IV adenocarcinoma of the pancreas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
- Men or women age ≥18 years
- Histologically confirmed metastatic (stage IV) adenocarcinoma of the pancreas
- Measurable disease defined per RECIST
- Karnofsky Performance Status ≥50
- Expected survival ≥12 weeks
- Provide written informed consent
- CNS metastases
- Prior treatment with other chemotherapy for pancreatic cancer unless used as a radiosensitizer
- Radiation therapy to >25% of the bone marrow
- Clinically significant laboratory abnormalities
- Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
- The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy with >10mg/day prednisone equivalents
- Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
- Patients who are within 28 days of radiation therapy, biologic therapy, immunotherapy, or other investigational medication. All side effects of prior treatment must have resolved at study entry.
- Pregnancy or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 6 month survival
- Secondary Outcome Measures
Name Time Method overall survival progression-free survival (PFS) quality of life pain performance status
Trial Locations
- Locations (27)
Gulfcoast Oncology Associates
🇺🇸St. Petersburg, Florida, United States
Northwest Alabama Cancer Center, PC
🇺🇸Muscle Shoals, Alabama, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Cancer Center of the Carolinas
🇺🇸Greenville, South Carolina, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
Hematology-Oncology Associates of Rockland
🇺🇸New City, New York, United States
Oncology Associates, PC
🇺🇸Hartford, Connecticut, United States
New York Oncology Hematology/Albany Regional Cancer Center
🇺🇸Albany, New York, United States
Dayton Oncology and Hematology
🇺🇸Kettering, Ohio, United States
Cancer Care Center, Inc.
🇺🇸New Albany, Indiana, United States
Yagnesh V. Oza, MD
🇺🇸Mt. Vernon, Illinois, United States
Mary Crowley Medical Research Center
🇺🇸Dallas, Texas, United States
Palm Beach Institute of Hematology and Oncology
🇺🇸Boynton Beach, Florida, United States
Indiana Oncology Hematology Consultants
🇺🇸Indianapolis, Indiana, United States
Oregon Clinic, The
🇺🇸Portland, Oregon, United States
Lawrence M. Stallings, MD
🇺🇸Wooster, Ohio, United States
Cancer Center of Florida
🇺🇸Ocoee, Florida, United States
Hematology Oncology Associates of Central Brevard
🇺🇸Rockledge, Florida, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Saint Luke's Episcopal Hospital
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Texas Oncology, PA, Presbyterian
🇺🇸Dallas, Texas, United States
Huron Medical Center
🇺🇸Port Huron, Michigan, United States
Medical Oncology LLC
🇺🇸Baton Rouge, Louisiana, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Elkins Pancreas Center
🇺🇸Houston, Texas, United States
Trilogy Cancer Center
🇺🇸Wooster, Ohio, United States