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Title:
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB ( greater than 4 cm) - IIIA Non-Small Cell Lung Cancer (NSCLC) E1505
Protocol Number:
E1505
Phase:
Phase III
Physician:
Julie Brahmer
Purpose:
To determine the toxicities, disease free survival and overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB( greater than / equal to 4cm)-IIIA NSCLC. To also determine whether smoking status is linked to outcome for these patients
Eligibility:
Complete resection of non-small lung cancer prior to enrollment(not less than than 6 weeks or greater than 12 weeks post thorocotomy and must have recovered adequately from surgery); greater than / equal to 18 yrs old;ECOG PS 0-1; No Prior chemo, hormonal or RT as prior cancer treatment within 5 yrs of randomization;adequate bone marrow,hepatic and renal function; greater than 12 month history of MI or angina; no h/o CVA or TIA; no pregnant or breast feeding females; must have negative blood or urine test if female of childbearing potential; both fertile men and women must use an adequate form of contraception during and 6 months post treatment; no h/o bleeding or coagulopathy; pts with post-op hemoptysis( greater than 1/2 tsp or more of bright red blood)are not eligible; pts. with resolved pre-op hemoptysis are eligible; no antiplatelet medication allowed(daily treatment with NSAIDS or aspirin allowed);no surgery, trauma, non-healing wound, fracture, ulcer, open bx within 28 days of randomization, or core bx within 7 days of randomization; no anticipatied major surgical procedures during the study; no known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies; may be on a stable therapeutic or prophylactic anticoagulation regimen as long as PT/INR less than / equal to 3.0
Treatment:
ARM A: consists of one of the following 3 treatment regimens selected by the investigator 1)Vinorelbine 30 mg/m2 IV push over 10 minutes days 1& 8 followed immediately by Cisplatin 75 mg/m2 over 1 hour DAY 1 ONLY 2) Docetaxel 75 mg/m2 IV over 1 hr Day 1 followed immediately by Cisplatin 75 mg/m2 IV over 1 hour Day 1 3) Gemcitabine 1200mg/m2 IV over 30 minutes on days 1&8 followed immediately by Cisplatin 75mg/m2 IV over 1 hour DAY 1 ONLY; All regimens will be given every 21 days for a total of 4 cycles; if unacceptable toxicity or progressive disease ocurs treatment will be discontinued ARM B: any one of the regimens in ARM A plus Bevacizumab Bevacizumab 15mg/kg IV given immediately following one of the ARM A regimens; Bevacizumab will continue alone for up to 1 year following the initial 4 cycles unless the patient develops unacceptable toxicities or progressive disease. (1 yr will be measured from the first day of protocol treatment)
Population:
Adult
Last Update
05/18/2013 04:02 AM
 

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