Biweekly TAS-102 with Bevacizumab combination study

Conditions

metastatic colorectal carcinoma

Masato Nakamura, Hironaga Satake, Koji Oba, Masahito Kotaka, Yoshinori Kagawa et al. (20 authors)

Journal of Clinical Oncology2020-02-011 citations

10.1200/jco.2020.38.4_suppl.121

Multicenter phase Ib/II study of biweekly trifluridine/tipiracil with bevacizumab combination for patients with metastatic colorectal cancer refractory to standard therapies (BiTS study).

Masahito Kotaka, Hironaga Satake, Koji Oba, Yoshinori Kagawa, Hisateru Yasui et al. (20 authors)

Journal of Clinical Oncology2019-01-292 citations

10.1200/jco.2019.37.4_suppl.647

Interventions

biweekly TAS-102 plus Bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. written informed consent 2. age >= 20y 3. histologically proven colorectal adenocarcinoma with metastatic disease 4. prior treatment history including fluoropyrimidine, irinotecan, oxaliplatin and anti-EGFR (in case of RAS WT) 5. ECOG PS <2 6. capable oral intake 7. evaluable lesions on the basis of RECIST v1.1 8. adequate organ function a. Hb >= 8.0 g/dL b. Neutrophil >= 1500/ mm3 c. Plt >= 75,000/ mm3 d. T-Bil <= 1.5 md/dL e. AST/ALT <=100IU/L (in case of liver metastasis <= 200 IU/L) f. serum creatinine <= 1.5 md/dL 9. a woman who have no plan to get pregnant 10. with an appropriate mental capacity

Exclusion criteria

Exclusion criteria: 1. any of the following complication: a. synchronous active malignancies other than carcinoma in situ or mucosal cancer b. central nervous system metastases c. active infection d. uncontrolled ascites, pleural effusion, pericardial effusion e. bowel obstruction, renal failure, liver failure, effusion f. uncontrolled DM g. uncontrolled hypertension h. symptomatic heart disease within 12 months i. active gastrointestinal bleeding j. uncontrolled HIV infection, HBV infection, HCV infection k. immunodeficency l. sever mental disorder 2. any of the following treatment: a. thoracotomy, or intestinal resection within 4 weeks b. chemotherapy within 1 week c. extensive radiotherapy d. investigational new drug within 1 week 3. history of TAS-102 4. grade 2 or more adverse events not recovered 5. transfusion within 7 days 6. urine dipstick for proteinuria more than +2 7. severe thrombosis or severe pulmonary disease 8. unhealed wound 9. hemorrhagic diathesis 10. pregnant and lactating females 11. patients judged by the investigator as unfit to be enrolled in the study

Design outcomes

Primary

Measure	Time frame
Phase Ib part MTD Phase II part 16w PFS rate by investigators' assessmenT	—

Countries

Japan

Contacts

Public ContactHironaga Satake

Kobe City Medical Center General Hospital Department of Medical Oncology

hsatake@kcho.jp81783024321

Outcome results

None listed