Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
cetuximab, epidermal growth factor receptor, antibody, non-small cell lung cancer, carboplatin, paclitaxel
Brief summary
The study will enroll approximately 33 EGFr positive chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for efficacy and safety throughout the duration of the study.
Detailed description
The study will enroll approximately 33 chemotherapy-naive stage IV non-small cell lung cancer patients. Patients will receive 3-week cycles of therapy with the exception of the initial cycle where the patients will receive 4 cycles of therapy. Patients will be enrolled after EGFr expression is confirmed and the study inclusion and exclusion criteria are met. An initial dose of cetuximab will be administered prior to the initiation of chemotherapy. Thereafter, cetuximab will be infused weekly. On the first day of each cycle, a paclitaxel infusion will be administered post completion of the cetuximab infusion, immediately followed by a carboplatin infusion. Patients will receive cetuximab in combination with carboplatin and paclitaxel for two cycles or until disease progression or until the patient exhibits intolerable toxicities. Patients will be evaluated for a tumor response at the end of every two cycles of therapy and evaluated for safety throughout the study.
Interventions
BIOLOGICALcetuximab
400 mg/m2 i.v. over 120 minutes
DRUGpaclitaxel
225 mg/m2, infusion
DRUGcarboplatin
30-minute AUC = 6, infusion.
Sponsors
University of Colorado, Denver
Greenwich Hospital
Indiana University
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The following inclusion criteria must be met: * The patient has stage IV NSCLC with either present or prior histologic or pathologic confirmation of NSCLC * The patient has uni-dimensionally measurable stage IV NSCLC * The patient has chemotherapy-naive stage IV NSCLC. The patient may have recurrent disease if prior radiation therapy was received. Pathological confirmation of recurrence is required for disease within a radiation portal. * The patient's ECOG performance status is ≤ 2 at study entry. * The patient has immunohistochemical evidence of EGFr expression (≥1+). Patients who do not have tumor tissue available for EGFr testing will undergo a biopsy of an accessible tumor. EGFr expression must be confirmed prior to study entry. * The patient has given signed informed consent. * The patient is 18 years of age or older. * The patient has adequate hematologic function, as defined by an absolute neutrophil (ANC)≥ 1,500/mL3 , a WBC count≥3,000/mL3, a platelet count ≥100,000/mL3, and a hemoglobin level ≥9g/dL. * The patient has adequate hepatic function as defined by a total bilirubin level ≤1.5 X the upper limit of normal (ULN) and an alkaline phosphatase, AST, and ALT level ≤2.5 X the ULN. * The patient has adequate renal function with a serum creatinine level ≤1.5 mg/dL or a creatinine clearance ≥60 cc/minute. * The patient is disease free from a previously treated malignancy, other than the disease under study, for greater than 3 years (patients with a history of a previous basal cell carcinoma of the skin or preinvasive carcinoma of the cervix will not be excluded). * The patient, if a woman, agrees to use effective contraception if childbearing potential exists. The patient, if a man, agrees to use effective contraception.
Exclusion criteria
The following ten
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the safety profile of cetuximab when used in combination with paclitaxel and carboplatin | 8 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor activity | 8 Weeks |
| Effect of cetuximab on the pharmacokinetics of paclitaxel and carboplatin | 8 Weeks |
Countries
United States
Outcome results
None listed