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Table 2 Clinical trials of decitabine-based therapies for solid tumors

From: DNA methyltransferase inhibitors combination therapy for the treatment of solid tumor: mechanism and clinical application

Drugs used in combination with decitabine Regimen Tumor types Phase Patient number Results Major toxicity Response pulse stable disease rate (%) Year
Cisplatin DAC in four (I–IV) dose escalation levels (45, 67, 90 to 120 mg/m/day 1–3) infusion followed by cisplatin 33 g/m2/day 1 infusion (21-day circle) Non small cell lung cancer (NSCLC) I/II 14 PD:14/14 Neutropenia and thrombocytopenia 0 2000
Cisplatin DAC 50 mg/m2/day followed by cisplatin 30 g/m/day 3-h infusion (21-day cycle) Advanced cervical cancer(most of them are squamous cell carcinoma of the cervix) II 25 PR:8/21 SD:5/21 PD:8/21 Hematologic toxicity 62 2002
Carboplat DAC 90 mg/m2 on day1 6-h infusion followed by carboplat in on day8 (28-days circle) Solid tumors (colon, breast, ovary, melanoma, sarcoma, gall bladder and pleural mesothelioma) I 35 PR:1/10 SD:3/10 PD:6/10 Myelosuppression 40 2007
Carboplat DAC (10 or 20 mg/m2/day1-8 and carboplatin on day 8 (28-day cycle) Platinum-resistant ovarian cancer I 10 CR:1/10 SD:6/10 PD:3/10 Nausea, allergic reactions and neutropenia 70 2010
Carboplat DAC 10 mg/m2 for day1-5 and carboplatin on day 8 (28-day cycle) Platinum-resistant ovarian cancer II 17 CR:1/17 PR:5/17 SD:6/17 PD:5/17 Nausea 70 2012
Carboplat DAC 90 mg/m2 day1 infusion followed by carboplat infusion on day 8 (28-days circle) Relapsed ovarian cancer II 15 PR + SD:1/12 PD:11/12 Neutropenia 8 2014
Carboplat DAC 7 mg/m2 day 1–5 followed by reduced TC treatment (28-day circle) Relapsed or refractory ovarian cancer I/II 21 PR:3/17 SD:9/17 PD:5/17 Nausea and neutropenia 71 2015
Carboplat DAC 7 mg/m2 day 1–5 followed by reduced TC treatment on day 6 (28-days circle) Recurrent ovarian cancer I/II 40 CR:1/40 PR:8/40 SD:19/40 PD:12/40 Nausea 74 2017
Doxorubicin and cyclophosphamide DAC (5–10 mg/m2/day 1–7 1-h infusion followed by doxorubicin (45 mg/m) and cyclophosphamide (1 g/m) on day 7 Children refractory solid tumors (neuroblastomar,habdomyosarcoma, osteosarcoma) I 21 SD:7/21 PD:14/21 Neutropenia and thrombocytopenia 33 2010
Vorinostat DAC 10 mg/m2/day1-5 and vorinostat 200 mg twice a day on days6-12 (28-days circle) Advanced solid tumors and non-Hodgkin’s lymphomas I/II 43 SD:11/38 PD:27/38 Neutropenia and thrombocytopenia 29 2011
anti-EGFR DAC 45 mg/m2/day 1 and 15 and followed by anti-EGFR 6 mg/kg /day 8 and 22 (28-day cycle) wt KRAS metastatic colorectal cancer I/II 20 PR:2/20 SD:10/20 PD:8/20 Rash and hypomagnesemia 60 2013
Vemurafenib 3 + 3 dose escalation combining subcutaneous decitabine at different doses and schedules (4 cohorts) with the standard oral dose of vemurafenib 960 mg twice daily Metastatic melanoma I/II 14 CR:3/14 PR:3/14 SD:5/14 OD:3/14 Fatigue and increased creatinine 79 2017