Status:
COMPLETED
Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
Lead Sponsor:
Veeda Oncology
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine the efficacy (response rate) of cetuximab when administered in combination with docetaxel and carboplatin for treatment of patients with advanced no...
Detailed Description
This is a phase II, open label, non-randomized study in patients with histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC who have not received prior ...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC.
- Age \> 18 years.
- ECOG PS 0-1.
- No prior chemotherapy for NSCLC.
- Measurable disease by RECIST criteria.
- Signed IRB-approved informed consent.
- Adequate bone marrow function defined by: peripheral absolute neutrophil count (ANC) \>1500/microL, hemoglobin \>9.0 g/dL, and platelet count \>100,000/microL.
- Adequate renal function as defined by serum creatinine level less than institutional upper limit of normal (ULN) or calculated/measured creatinine clearance \> 65 mL/min.
- Adequate liver function defined as: serum total bilirubin \<ULN, serum aspartate aminotransferase (AST) \<2.5 times ULN.
- Estimated life expectancy \>12 weeks.
Exclusion
- Untreated clinically active brain metastasis.
- Radiotherapy within 2 weeks prior to registration or previous irradiation to the only area of measurable disease.
- Treatment with any investigational therapy within 4 weeks prior to registration.
- Prior therapy with an agent that is known to specifically and directly target the EGFR pathway.
- History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years.
- Patients in their reproductive age group should consent to use an effective method of birth control while on treatment and for at least 3 months thereafter. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study.
- Major surgery within 3 weeks prior to registration.
- Use of immunosuppressive agents including systemic corticosteroids within 4 weeks prior to registration (corticosteroids are permitted as physiological replacement therapy or as supportive care for nausea and emesis).
- Known history of human immunodeficiency virus infection.
- Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator.
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- Concurrent serious infection.
- History of known hypersensitivity to docetaxel or other drugs formulated with polysorbate 80.
- History of prior severe infusion reaction to a monoclonal antibody.
- Patient has \>Grade 2 peripheral neuropathy within 14 days prior to registration
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00251498
End Date
October 1 2007
Last Update
August 21 2008
Active Locations (1)
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1
Veeda Oncology
Houston, Texas, United States, 77042