Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer
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 chemotherapy. The trial will evaluate the efficacy and
safety profile of the combination of docetaxel, carboplatin and cetuximab for patients with
advanced NSCLC.
Patients will receive a combination of docetaxel and carboplatin administered every 3 weeks
plus cetuximab given weekly. A maximum of four cycles of chemotherapy will be administered
to patients. Patients who demonstrate an ongoing response (CR/PR/SD) at the end of 4th
cycle of chemotherapy, may receive two more cycles of treatment. Patients who continue to
respond (CR/PR/SD) after six cycles of therapy may receive therapy with single agent
cetuximab (250 mg/m2/week) for up to 1 year or until disease progression or unacceptable
toxicity, whichever occurs first.
Patients will be evaluated for response, time to progression, and overall survival. In
addition, the safety profile of the combination will be assessed.
Inclusion Criteria:
- 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
- Estimated life expectancy >12 weeks.
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Chandra Belani, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Veeda Oncology
Authority:
United States: Food and Drug Administration
Study ID:
I-04-002
NCT ID:
NCT00251498
Start Date:
Completion Date:
October 2007
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Metastatic 1st line NSCLC
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Veeda Oncology | Houston, Texas 77042 |
