Journal Article

Gemcitabine and docetaxel combination chemotherapy for advanced bone and soft tissue sarcomas: protocol for an open-label, non-randomised, Phase 2 study

Hara, Hitomi, Nishida, Kotaro, Kawamoto, Teruya, Kawakami, Yohei, Fujiwara, Shuichi, Fukase, Naomasa, Kitayama, Kazumichi, Akisue, Toshihiro, Kuroda, Ryosuke, Takemori, Toshiyuki

2019

Overview

Background The prognosis of patients with metastatic or advanced sarcomas is poor and there are few options for treatment. Several studies have shown that gemcitabine and docetaxel (GD) combination chemotherapy has antitumor activity against various subtypes of sarcoma. Recently, some studies have shown a favourable outcome for GD combination chemotherapy for relapsed high-grade osteosarcoma and spindle cell sarcoma of bone. If the effectiveness of GD is proven, this will result in new treatment options for advanced bone and soft tissue sarcomas (STS). The aim of this prospective Phase 2 study is to evaluate the efficacy and toxicity of the GD combination in patients with advanced bone sarcomas and STS. Methods This is a Phase 2, single-arm, open-label study to investigate the efficacy and safety of combination chemotherapy with GD for advanced bone sarcomas and STS and will enrol 20 patients. The patients will receive gemcitabine 900 mg/m 2 on Days 1 and 8, and docetaxel 70 mg/m 2 on Day 8 in 3-week cycles until disease progression or other evidence of treatment failure. The primary aim of this study is to analyse GD’s effect on progression-free survival (PFS). The secondary objectives are to analyse treatment efficacy and safety in terms of response rate, tumour control rate, overall survival, and adverse event rate. The length of follow-up will be 5 years. Discussion This study will evaluate the efficacy and safety of combination therapy with gemcitabine and docetaxel for bone sarcomas and STS. If this combination proves to be acceptable, it could be used for as second, third, or later line therapy for patients with sarcomas (especially bone sarcomas). In the future, the role of various treatments, including GD therapy, will be clarified for specific subtypes of sarcoma. Trial registration This study was registered as UMIN000031004 (University Hospital Medical Information Network-Clinical Trial Registry: UMIN-CTR) on 1 March 1 2018 and with the Japan Registry of Clinical Trials (jRCT) as jRCTs051180042 on 30 January 2019. The posted information will be updated as needed to reflect protocol amendments and study progress.

• Publisher: BioMed Central,BioMed Central Ltd,BMC
• Subject: Adolescent / Adult / Aged / Antineoplastic agents / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Biomedical and Life Sciences / Biomedicine / Bone and soft tissue sarcomas / Bone cancer / Bone Neoplasms - drug therapy / Bone Neoplasms - mortality / Bone Neoplasms - pathology / Cancer / Cancer metastasis / Cancer Research / Cancer treatment / Chemotherapy / Child / Clinical trials / Clinical Trials, Phase II as Topic / Combination drug therapy / Deoxycytidine - analogs & derivatives / Deoxycytidine - therapeutic use / Docetaxel / Docetaxel - therapeutic use / Dosage and administration / Drug therapy / Female / Follow-Up Studies / Gemcitabine / Gemcitabine and docetaxel / Health Promotion and Disease Prevention / Humans / Labels / Male / Medical and radiation oncology / Medicine/Public Health / Methods / Middle Aged / Neoplasm Staging / Oncology / Osteosarcoma / Osteosarcoma - drug therapy / Osteosarcoma - mortality / Osteosarcoma - pathology / Phase 2 study / Prognosis / Progression-Free Survival / Prospective Studies / Sarcoma / Soft Tissue Neoplasms - drug therapy / Soft Tissue Neoplasms - mortality / Soft Tissue Neoplasms - pathology / Study Protocol / Surgical Oncology / Testing / Toxicity / Tumors / Young Adult