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

1149 - J-FORCE study: A randomized, double-blind, placebo-controlled phase III study evaluating olanzapine (5 mg) combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based, highly emetogenic chemotherapy

Date

10 Sep 2017

Session

Poster display session

Presenters

Hironobu Hashimoto

Citation

Annals of Oncology (2017) 28 (suppl_5): v543-v567. 10.1093/annonc/mdx388

Authors

H. Hashimoto1, S. Iwasa2, M. Abe3, T. Yanai1, S. Zenda4, T. Yamaguchi5, H. Kaba6, H. Fukuda7, H. Terakado1, Y. Ohe8

Author affiliations

  • 1 Pharmacy, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2 Department Of Gi Medical Oncology, National Cancer Center Hospital, Tokyo/JP
  • 3 Department Of Gyne Oncology, Shizuoka Cancer center, Shizuoka/JP
  • 4 Department Of Radiation Oncology, National Cancer Center Hospital East, Chiba/JP
  • 5 Biostatistics, Tohoku University Graduate School of Medicine, Sendai/JP
  • 6 Data Management Section, National Cancer Center, Tokyo/JP
  • 7 Data Management Section, National Cancer Center Hospital, Tokyo/JP
  • 8 Department Of Thoracic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
More

Resources

Abstract 1149

Background

In the Alliance A221301 study, olanzapine (OLZ; 10 mg) significantly improved the prevention of nausea in patients who were receiving highly emetogenic chemotherapy (HEC). However, growing concerns exist concerning somnolence and sedation. We previously reported on the efficacy and safety of two doses (5 mg and 10 mg) of OLZ in combination with aprepitant (APR), palonosetron (PALO), and dexamethasone (DEX) in patients receiving HEC. OLZ (5 mg) seemed to lead to lower somnolence than OLZ (10 mg) and was equally effective in preventing nausea. The aim of this phase III study is to evaluate the efficacy and safety of 5 mg OLZ doses as compared with placebo, in combination with APR, PALO, and DEX, for the control of nausea in patients receiving HEC.

Trial design

Eligibility criteria for patients include those who are aged 20–75 years, have an Eastern Cooperative Oncology Group (ECOG) performance status between 0–2, and have malignant disease who will be scheduled to receive HEC with cisplatin at a dose ≥ 50 mg/m2. Having diabetes mellitus or being treated with antipsychotic agents within 48 hours before enrollment make patients ineligible for the study. Patients are randomly assigned to receive either a 5 mg OLZ dose or placebo orally after supper on days 1–4, in combination with APR (125 mg p.o. on day 1, 80 mg p.o. on days 2–3), PALO (0.75 mg i.v. on day 1) and DEX (9.9 mg i.v. on day 1 and 6.6 mg i.v. on days 2–4). The primary endpoint is a complete response (CR), defined as no emetic episodes and without the use of rescue medications in the delayed phase (24 to 120 hours). Secondary endpoints include a CR during acute (0 to 24 hours) and overall phases (0 to 120 hours), complete and total control rates, and the level of nausea, appetite and somnolence. A total of 690 patients are required to achieve 80% power for a one-sided significance level of 0.025. We expect the CR rate of the placebo and olanzapine arms to be 65% and 75%, respectively.

Clinical trial identification

UMIN000024676

Legal entity responsible for the study

Japan Supportive, Palliative and Psycho Social Oncology Group

Funding

Japan Agency for Medical Research and Development

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
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.