Clinical trial NCT00116389: Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
Official title: An Open-Label Phase 2 Trial of Talabostat and Gemcitabine in Patients With Stage IV Adenocarcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Neoplasm Metastasis
Adenocarcinoma
Keywords: pancreatic cancer
cancer of the pancreas
adenocarcinoma of the pancreas
pancreatic neoplasms
Metastatic pancreatic cancer (Stage IV)
Stage IV Adenocarcinoma of the Pancreas
Lead sponsor: Point Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 6 month survival
Secondary outcomes:
measure: overall survival
measure: progression-free survival (PFS)
measure: quality of life
measure: pain
measure: performance status
Other outcomes:
Locations:
city: Florence
country: United States
facility: Northwest Alabama Cancer Center, PC
state: Alabama
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center, PC
state: Alabama
city: Hartford
country: United States
facility: Oncology Associates, PC
state: Connecticut
city: Boynton Beach
country: United States
facility: Palm Beach Institute of Hematology and Oncology
state: Florida
city: Ocoee
country: United States
facility: Cancer Center of Florida
state: Florida
city: Rockledge
country: United States
facility: Hematology Oncology Associates of Central Brevard
state: Florida
city: St. Petersburg
country: United States
facility: Gulfcoast Oncology Associates
state: Florida
city: Mt. Vernon
country: United States
facility: Yagnesh V. Oza, MD
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Oncology Hematology Consultants
state: Indiana
city: New Albany
country: United States
facility: Cancer Care Center, Inc.
state: Indiana
city: Baton Rouge
country: United States
facility: Medical Oncology LLC
state: Louisiana
city: Port Huron
country: United States
facility: Huron Medical Center
state: Michigan
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Long Branch
country: United States
facility: Monmouth Medical Center
state: New Jersey
city: Albany
country: United States
facility: New York Oncology Hematology/Albany Regional Cancer Center
state: New York
city: New City
country: United States
facility: Hematology-Oncology Associates of Rockland
state: New York
city: Kettering
country: United States
facility: Dayton Oncology and Hematology
state: Ohio
city: Wooster
country: United States
facility: Lawrence M. Stallings, MD
state: Ohio
city: Wooster
country: United States
facility: Trilogy Cancer Center
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Clinic, The
state: Oregon
city: Greenville
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA, Presbyterian
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Elkins Pancreas Center
state: Texas
city: Houston
country: United States
facility: Saint Luke's Episcopal Hospital
state: Texas
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
Study officials:
References: