|Principal Name||Harvey Zimbler, MD|
|Contact Name||Gloria Gero|
|Alternate Phone||(413) 443-6000|
|Title||S0819 - " A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab With or Without Concurrent Cetuximab in Patients with Advanced Non-Small Cel Lung Cancer (NSCLC)|
|Description||Primary objective of this study is:|
Overall survival in the entire study popluation
Prgression-free survival by institutional review in EGFR FISH-positive patients
Chemoterhapy without Detuzimab =/- Bevacizumab
Chemotherapy with Cetuximab +/- Bevacizumab
|Inclusion/Notes||Eligibility /Ineligibility Criteria:|
-Patients must have histologically or cytologically proven primary non-small cell lung cancer (adenocarcinoma, large
cell carcinoma,k squamous or unspecified). Disease must be Stage IV. Disease may be either newly diagnosed or
recurrent after previous surgery and/or irradiaiton.
- Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to registration.
Patietn must not have brain metastatses unsess: 1) metastatses have been treated and have remained controlled
for at least two weeks following treatment, AND 2) patient has no residual neurological dysfunction off
corticosteroids for at least 1 day.
- Patient may have measurable or non-measurable disease docemented by CT or MRI.
-Transitional Medicine Studies: Patientsmust have tumor tissue available for submission that is sufficient for EGFR
FISH testing and must agree to submission of these specimens.
- Patients must not have received prior chemotherapy for any stage non-small cell lung cancer. Patients must not
have received prior platinnum-based chemotherapy for any purpose. Patients must not have received any
cetuzimab, gefitinib, erlotinib, or other investigational agents that target the EGFR pathway. Patients must not have
received for any purpose prior bevacizumab or other VEGF-related agents.
- Prior radiation is permitted; however, pateints must have recovered from all associated toxities at time of
- Tiome from surgical or biopsy procedures is dependent on whether it is planned for the patient to recieve bevacizumab.
- Patients must have an ANC> 1500/mcl, platelet count >100,000/mcl and hemoglobin > 9 g/dl obtained within 14 days prior to registration.
- Patients must have a serum creatinien < instttuional upper limit of normal and calculated or measured creatinine clearance > 50 cc/min using the Cockroft-Gault Formula
- For patients who will receive bevacizumab, urine protein must be screened by urine analysis for UPC ratio.
- Patients must have adequate hepatic function documented by serum bilirun,2 x ULN and either SGOT or SGPT < 2x ULN within 14 days prior to registration.
- Patients must have a Zubrdo Performance Status of 0-1
Patient must not have > Grade 2 symptomatic neuropathy-sensory
Patients must not have documented evidence of acute hpeatitis or have an active or uncontrolled infeciton.
Patients must not have the following: history(within past 6 months) of CVA, mycoaradial infarciton or unstable angina; unctontrolled hypertension.
- Patients mut be willing to provide prior smoking history
- No prior maglinancy is allowed except for the following; adequately treated basal cell or squamous cell skin cancer, ins itu cervical cancer, adequately treated Stage I or II cancer fom which the patient is currently in complete remission, or any other cancer from which teh patient has been disease free or 5 years.
- Patients must not be pregnant or nusince
-----Patients must be informed of the invbestigatinal nature of the study and must sig and give written informaed consent in accordance with institutional and federal guidelines.
|Current Trial Type||treatment|