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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Northwest Alabama Cancer Center, PC, Muscle Shoals, Alabama 35661, United States
Northwest Alabama Cancer Center, PC, Florence, Alabama 35630, United States
Oncology Associates, PC, Hartford, Connecticut 06106, United States
Gulfcoast Oncology Associates, St. Petersburg, Florida 33705, United States
Cancer Center of Florida, Ocoee, Florida 34761, United States
Palm Beach Institute of Hematology and Oncology, Boynton Beach, Florida 33435, United States
Hematology Oncology Associates of Central Brevard, Rockledge, Florida 32955, United States
Yagnesh V. Oza, MD, Mt. Vernon, Illinois 62864, United States
Indiana Oncology Hematology Consultants, Indianapolis, Indiana 46202, United States
Cancer Care Center, Inc., New Albany, Indiana 47150, United States
Medical Oncology LLC, Baton Rouge, Louisiana 70809, United States
Huron Medical Center, Port Huron, Michigan 48060, United States
Billings Clinic, Billings, Montana 59101, United States
Monmouth Medical Center, Long Branch, New Jersey 07740, United States
New York Oncology Hematology/Albany Regional Cancer Center, Albany, New York 12208, United States
Hematology-Oncology Associates of Rockland, New City, New York 10956, United States
Dayton Oncology and Hematology, Kettering, Ohio 45409, United States
Trilogy Cancer Center, Wooster, Ohio 44691, United States
Lawrence M. Stallings, MD, Wooster, Ohio 44691, United States
Providence Portland Medical Center, Portland, Oregon 97213-2933, United States
Oregon Clinic, The, Portland, Oregon 97213, United States
Cancer Center of the Carolinas, Greenville, South Carolina 29615, United States
Mary Crowley Medical Research Center, Dallas, Texas 75201, United States
Texas Oncology, PA, Presbyterian, Dallas, Texas 75231, United States
Elkins Pancreas Center, Houston, Texas 77030, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Saint Luke’s Episcopal Hospital, Houston, Texas 77030, United States
Cancer Care Northwest, Spokane, Washington 99218, United States
