Phase I study of capecitabine, oxaliplatin, bevacizumab, and everolimus in advanced solid tumors View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2014-08

AUTHORS

Fatima Rangwala, Johanna C. Bendell, Mark F. Kozloff, Christy C. Arrowood, Andrew Dellinger, Jennifer Meadows, Sandra Tourt-Uhlig, Jennifer Murphy, Kellen L. Meadows, Aijing Starr, Samuel Broderick, John C. Brady, Stephanie M. Cushman, Michael A. Morse, Hope E. Uronis, S. David Hsu, S. Yousuf Zafar, James Wallace, Alexander N. Starodub, John H. Strickler, Herbert Pang, Andrew B. Nixon, Herbert I. Hurwitz

ABSTRACT

PURPOSE: To define maximum tolerated dose (MTD), toxicities, and pharmacodynamics of capecitabine, oxaliplatin, bevacizumab, and everolimus in advanced solid tumor patients. DESIGN: This was a standard "3 + 3" dose-escalation trial. All subjects received bevacizumab 7.5 mg/kg on day 1 of each cycle. Doses for capecitabine, oxaliplatin and everolimus were modified per dose limiting toxicity (DLT). Baseline and on-treatment plasma biomarkers were analyzed. Archived tumor mRNA levels were evaluated for NRP1, NRP2 and VEGF-A isoforms. RESULTS: Twenty-nine patients were evaluable for toxicity and 30 for efficacy. Two DLTs were observed in cohort 1 and one DLT each was observed in cohort -1 and -1b. Grade ≥3 toxicities included neutropenia, hypertension, perforation/fistula/hemorrhage, hypertriglyceridemia, diarrhea, and thromboembolism. Twelve subjects experienced partial response (PR); 12 had stable disease as best response. Three of seven chemorefractory metastatic colorectal cancer (mCRC) subjects experienced PR; 8 of 15 chemonaive mCRC subjects experienced PR. Plasma TβRIII and IL-6 increased on treatment but without correlation to outcome. Increased VEGF165 levels significantly correlated with longer progression free survival. CONCLUSIONS: Everolimus with full dose capecitabine, oxaliplatin, and bevacizumab had unacceptable toxicity. MTD was: everolimus 5 mg daily; capecitabine 680 mg/m(2) BID days 1-14; oxaliplatin 100 mg/m(2) and bevacizumab 7.5 mg/kg, day 1. Activity was noted in mCRC. More... »

PAGES

700-709

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10637-014-0089-2

DOI

http://dx.doi.org/10.1007/s10637-014-0089-2

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1011851236

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24711126


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467 Goshen Center for Cancer Care, 46526, Goshen, IN, USA
468 rdf:type schema:Organization
 




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