Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session

3592 - Safety analysis of phase Ib study of FOLFOXIRI plus ramucirumab as first-line therapy for patients with metastatic colorectal cancer

Date

09 Sep 2017

Session

Poster display session

Presenters

Hiroya Taniguchi

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

H. Taniguchi1, Y. Kito2, H. Satake3, Y. Horie4, T. Yamada5, T. Esaki6, T. Denda7, K. Mori8, K. Yamazaki9

Author affiliations

  • 1 Department Of Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 2 Department Of Medical Oncology, Ishikawa Prefectural Central Hospital, 920-8530 - Kanazawa/JP
  • 3 Department Of Medical Oncology, Kobe City Medical Center General Hospital, Kobe/JP
  • 4 Department Of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki/JP
  • 5 Division Of Gastroenterology, University of Tsukuba, Tsukuba/JP
  • 6 Department Of Gastrointestinal And Medical Oncology, National Kyushu Cancer Center, Fukuoka/JP
  • 7 Division Of Gastroenterology, Chiba Cancer Center Hospital, 260-8717 - Chiba/JP
  • 8 Clinical Research Center, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 9 Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
More

Resources

Abstract 3592

Background

Ramucirumab (Rmab), an anti-VEGFR-2 antibody, inhibits VEGF-A, -C, -D binding and endothelial cell proliferation, although bevacizumab (Bmab) binds to and blocks circulating VEGF-A. We conducted a phase Ib study to determine the recommended phase II dose (RP2D) of FOLFOXIRI plus Rmab for metastatic colorectal cancer (mCRC) patients.

Methods

The eligibility criteria included patients with histologically confirmed unresectable colorectal adenocarcinoma, aged 20-75 years, ECOG PS 0-1 (patients > 70 years were eligible if their ECOG PS was 0), wild-type or heterozygous UGT1A1 *28 or *6, no history of prior chemotherapy, and adequate organ function. Three dose levels were planned as follows; oxaliplatin and Rmab dose was fixed at 85 mg/m2 and 8 mg/kg, respectively. Level 1: 5-fluorouracil (5-FU) 3200 mg/m2, irinotecan (IRI) 165 mg/m2, Level 0 as starting dose: 5-FU 2400 mg/m2, IRI 150 mg/m2, and Level -1: 5-FU 2400 mg/m2, IRI 120 mg/m2. Patients were enrolled with a 3 + 3 design manner to evaluate the dose-limiting toxicity (DLT) in the first cycle.

Results

From September 2016 to February 2017, we enrolled a total of 10 patients (4 patients in the Level 0 and 6 patients in the Level 1). The patients’ characteristics were as follows: median age (range), 64 (44-68); male/female, 6/4; ECOG PS 0/1, 8/2; RAS wild/mutant, 1/9; UGT1A1 *1*1/*1*28, 4/6. One patient was excluded for the DLT evaluation due to lack of safety evaluation on cycle 1 day 8. No DLT was observed in the 9 DLT-evaluable patients. In the first cycle, major adverse events were G 4 neutropenia (n = 2), G 3 neutropenia (n = 1), G 3 hypertension (n = 1), G 1/2 diarrhea (n = 6), G 1/2 anorexia (n = 3), G 2 allergic reaction (n = 1), G 1 fatigue (n = 4), G 1 peripheral neuropathy (n = 4), G 1 nausea (n = 2) and G 1 stomatitis (n = 2). G-CSF was administered in 2 patients during the first cycle.

Conclusions

The RP2D for FOLFOXIRI plus Rmab was determined at the Level 1. A randomized phase II study of FOLFIRI plus Rmab versus FOLFOXIRI plus Rmab for chemotherapy-naïve mCRC patients (WJOG9216G trial; UMIN000026527) is on-going. The update results will be presented in the congress.

Clinical trial identification

UMIN000023277

Legal entity responsible for the study

Shizuoka Cancer Center

Funding

Shizuoka Cancer Center

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings