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Clinical Trial
. 2018 Jul 31;18(1):771.
doi: 10.1186/s12885-018-4505-4.

An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without bevacizumab in platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer patients previously treated with bevacizumab for front-line or platinum-sensitive ovarian cancer: rationale, design, and methods of the Japanese Gynecologic Oncology Group study JGOG3023

Tadahiro Shoji  1 , Shinichi Komiyama  2 , Junzo Kigawa  3 , Hiroshi Tanabe  4 , Kazuyoshi Kato  5 , Hiroaki Itamochi  6 , Hiroyuki Fujiwara  7 , Shoji Kamiura  8 , Tetsutaro Hamano  9 , Toru Sugiyama  6 ; Japanese Gynecologic Oncology Group
Affiliations
Clinical Trial

An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without bevacizumab in platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer patients previously treated with bevacizumab for front-line or platinum-sensitive ovarian cancer: rationale, design, and methods of the Japanese Gynecologic Oncology Group study JGOG3023

Tadahiro Shoji et al. BMC Cancer. .

Abstract

Background: We present the study rationale and design of the JGOG3023 study, an open-label, parallel-arm, randomized, phase II trial that aimed to assess the efficacy and safety of chemotherapy with or without bevacizumab in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who were previously treated with bevacizumab for front-line or platinum-sensitive ovarian cancer. We hypothesize that patients treated with a combination of single-agent chemotherapy and bevacizumab will show improved progression-free survival (PFS) compared with those treated with single-agent chemotherapy alone, in the setting beyond disease progression following prior bevacizumab treatment.

Methods/design: A total of 106 patients who have recurrence or progression of ovarian cancer, while receiving chemotherapy or within 6 months after the final dose of platinum, after completing at least three cycles of bevacizumab plus platinum chemotherapy will be randomized in a 1:1 ratio to treatment with single-agent chemotherapy or single-agent chemotherapy combined with bevacizumab. For chemotherapy, one of the following four drugs will be chosen by an investigator: pegylated liposomal doxorubicin, topotecan, paclitaxel, or gemcitabine. The primary endpoint is investigator-assessed PFS. The secondary endpoints are overall survival, objective response rate, number of paracentesis, and response rate by CA125. Safety will be evaluated by the incidence of adverse events.

Discussion: This study will assess the efficacy and safety of bevacizumab in combination with single-agent chemotherapy, which could be used continuously after disease progression following standard platinum-based chemotherapy with bevacizumab.

Trial registration: UMIN000017247 (registered April 22, 2015).

Keywords: Bevacizumab; Beyond progression; Chemotherapy; Continued treatment; Ovarian cancer; Platinum-resistant ovarian cancer; Progression-free survival; Randomized clinical trial; Vascular endothelial growth factor.

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Conflict of interest statement

Ethics approval and consent to participate

Institutional review board approval has been obtained from each participating center. A full list of the ethics committees for each institution is provided in the Supplementary Information. All patients will be required to provide signed informed consent. This trial will be conducted according to the International Conference on Harmonization Guidelines for Good Clinical Practice, the Ethical Guideline for Medical and Health Research involving Human Subjects and applicable local laws and regulations.

Competing interests

T.Sh. has received honoraria for lectures and manuscript writing/editing from Chugai Pharmaceutical. S. Ko., J.K., H.T., H.I., S. Ka, and T.H. have received honoraria for lectures from Chugai Pharmaceutical. H.F. and T.Su. have received honoraria for lectures and research grant from Chugai Pharmaceutical. K.K. declares that he has no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design. Bevacizumab-pretreated, platinum-resistant ovarian cancer patients will be randomized 1:1 to treatment with chemotherapy alone or chemotherapy plus bevacizumab. *Defined as progression within < 6 months from completion of a minimum of three platinum therapy (including bevacizumab) cycles
See this image and copyright information in PMC

References

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