A phase II trial of TAS-102 in combination with cetuximab for metastatic colorectal cancer patients

JRCT ID: jRCTs041180156

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Metastatic RAS wild type colorectal cancer with refractory or intolerable to standard chemotherapy
• Date of first enrollment: 07/09/2017
• Target sample size: 55
• Study type: Interventional

Intervention(s)

TAS-102 (35 mg/m2/dose) will be administered orally BID on days1-5 and day8-12 every 28 days.
Cmab is administered once a week. The initial dose is 400 mg/m2. The subsequent weekly doses are 250 mg/m2 each.

Outcome(s)

• Primary Outcome: disease control rate
• Secondary Outcome: overall survival, progression free survival, response rate, safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)histopathologically confirmed unresectable or metastatic colorectal adenocarcinoma
2) Wild-type RAS status
3) Measurable disease by response evaluation criteria in solid tumors (RECIST version 1.1) criteria
4) refractory disease or unable to tolerate agents (fluoropyrimidines, irinotecan, oxaliplatin) and antiangiogenic agent (bevacizumab,ramucirumab and aflibercept), and refractory to anti-EGFR antibodies (cetuximab and panitumumab)
5) No prior TAS-102
6) Patients who have not had major surgery (i.e., thoracotomy or laparotomy) within 4 weeks prior to enrollment.
7) Patients who have not had radiotherapy for bone and/or brain metastases excluding primary colorectal cancer within 2 weeks prior to enrollment
8) Patients who have not had any chemotherapy within 2 weeks prior to enrollment
9) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
10) An estimated life expectancy of at least 12 weeks after enrollment
11) Is able to take medications orally
12) Patients must have the following adequate organ functions
13) Ability to understand and the willingness to sign a written informed consent document

Exclude criteria

1) Previous severe infusion reaction to Cmab
2) Another malignancy with less than 5 disease-free years
3) Presence of active local or systemic infection under treatment
4) Positive for Hepatitis B surface antigen
5) Radiographic evidence of severe pulmonary fibrosis or interstitial pneumonia on Computed Tomography
6) Symptomatic brain and/or leptomeningeal metastases which needs treatment
7) Serious complications
8) Clinically significant mental or psychological disorder
9) Patients requiring continuous treatment with systemic steroids
10) Females who are pregnant, breastfeeding, or with a positive pregnancy test or males and females of reproductive potential unwilling to use adequate contraception
11) Patients whose participation in the trial was judged to be inappropriate by the attending doctor

Related Information

• Primary Sponsor: Izawa Naoki
• Source(s) of Monetary Support: TAIHO PHARMACEUTICAL CO., LTD.,Merck Serono Co., Ltd.
• Secondary ID(s): UMIN000027210