Lung Cancer, Neoplasm Metastasis, Non-Small Cell Lung Cancer
Conditions
Keywords
Advanced, Non-Small-Cell, Lung, Cancer, NSCLC, Carcinoma, Advanced Non-Small-Cell Lung Cancer (NSCLC)
Brief summary
Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in combination with paclitaxel and carboplatin in the treatment of advanced NSCLC.
Interventions
Sponsors
Amgen
Study design
Allocation
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
For complete inclusion and
Exclusion criteria
, please refer to the investigator. Inclusion Criteria: - 18 years of age or older. - Pathological diagnosis of NSCLC. - Bidimensionally measurable disease. - Tumor tissue available for immunohistochemistry studies. - Tumor over-expressing EGFR as ascertained by immunohistochemistry. - Disease stage IIIB with pericardial or pleural effusion, or stage IV. - Life expectancy of at least 12 weeks. - Adequate hematology function - Adequate renal function - Adequate hepatic function - ECOG score of less than 2. - Brain metastases, if present; must be controlled and asymptomatic.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Disease Progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate at Week 5 | — |
| Survival Time | — |
| Progression Free Survival | — |
| Rate of Progressive Disease at Week 11 | — |
| Best Overall Response Rate | — |
| Lab Abnormalities and other Safety Parameters | — |
| PK of Panitumumab in Combination with Carboplatin and Paclitaxel | — |
| Quality of Life | — |
| Incidence of AEs | — |
Outcome results
None listed