Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
Phase 2 Study of Talabostat and Docetaxel in Advanced Non-Small Cell Lung Cancer
1 other identifier
interventional
N/A
1 country
10
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.
Trial Health
Trial Health Score
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10 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2004
CompletedFirst Posted
Study publicly available on registry
March 24, 2004
CompletedJune 8, 2007
June 1, 2007
March 23, 2004
June 7, 2007
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Cancer Center of Florida
Ocoee, Florida, 34761, United States
University of Chicago
Chicago, Illinois, 60637, United States
Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236, United States
New York Oncology/Hematology--Albany Regional Cancer Center
Albany, New York, 12208, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
USB Cancer Center-- Nyack Hospital
Nyack, New York, 10960, United States
Dayton Oncology & Hematology
Kettering, Ohio, 45409, United States
Mary Crowley Medical Research Center
Dallas, Texas, 75246, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Cancer Care Northwest
Spokane, Washington, 99218, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 23, 2004
First Posted
March 24, 2004
Last Updated
June 8, 2007
Record last verified: 2007-06