Clinical trial NCT00080080: Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
Official title: Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Point Therapeutics
Sponsor class: INDUSTRY
First posted: 2004-03-24
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 determine the antitumor activity (response rate, time to tumor progression, survival) and safety of docetaxel in combination with talabostat in patients with advanced non-small cell lung cancer (NSCLC) who have failed a prior platinum-containing regimen.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed Stage IIIb/IV NSCLC
* Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
* Measurable disease
* ECOG Performance Status of 0 or 1
* Expected survival ≥12 weeks
* Provide written informed consent

Exclusion Criteria:

* More than 2 prior chemotherapy regimens
* Brain metastases (exception: patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month)
* 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
* A history of severe hypersensitivity reactions to drugs formulated with polysorbate 80
* A history of myocardial infarction within 1 year of study entry, CABG within 6 months of study entry, severe congestive heart failure (ejection fraction \<30%), history of ventricular arrhythmia, or other uncontrolled cardiac arrhythmia
* 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 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC. Patients must have recovered from all of the side effects of treatment in order to be enrolled.
* Pregnant or lactating women.
* Clinically significant laboratory abnormalities, specifically:

Total bilirubin ≥institutional upper limit of normal (ULN); Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase \>2.5 x ULN; Hepatitis B surface antigen or antibody to Hepatitis C (anti-HCV antibody); Serum creatinine ≥2.0mg/dL; or Granulocytes \<1500/μL or platelets \<100,000/μL.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ocoee
country: United States
facility: Cancer Center of Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Grosse Pointe Woods
country: United States
facility: Van Elslander Cancer Center
state: Michigan
city: Albany
country: United States
facility: New York Oncology/Hematology--Albany Regional Cancer Center
state: New York
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: Nyack
country: United States
facility: USB Cancer Center-- Nyack Hospital
state: New York
city: Kettering
country: United States
facility: Dayton Oncology & Hematology
state: Ohio
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
Study officials:
References: