A Phase 2 study of concurrent combination therapy of TFTD (TAS-102) and bevacizumab in patients of more than 70 years of age with unresectable, advanced/recurrent colorectal cancer (KSCC 1602)

JRCT ID: jRCTs071180065

Registered date:20/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Colorectal Cancer
• Date of first enrollment: 05/01/2017
• Target sample size: 35
• Study type: Interventional
• Intervention(s): TFTD 35 mg/m2, po, bid at day 1-5 and day 8-12 and bevacizumab 5mg/kg, iv, every 2 weeks are concurrently administered. The administration is continued until the meeting of discontinuation criteria as 1 course of 28 days.

Outcome(s)

• Primary Outcome: Progression-Free Survival

Secondary Outcome

Response rate
Overall survival
Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 70age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients providing the written informed consent.
2) Patients are >=70 years of age.
3) Patients with colorectal cancer pathologically diagnosed.
4) Unresectable colorectal cancer and chemotherapy was not performed as pre-treatment (recurrent patients under adjuvant therapy and within 6 months after adjuvant therapy excluding adjuvant therapy for pathological stage II-III are ineligible)
5) Patients with any of the following:
(1) Patients who the standard therapy is possible, but does not enforce the standard therapy by the consultation of a investigator and patient (fit)
(2) Patients who cannot be received the same standard treatment as a general young people, but can be received some kind of treatment (vulnerable).
6) Performance Status (ECOG) 0 or 1
7) Patients capable of treatment with oral medicine
8) Patients have measurable lesion according to RECIST version 1.1 criteria by trunk part contract-enhanced CT within 28 days before enrollment
9) Patients with sufficient organ function
10) He/she can accept contraception by an appropriate method from the study drug administration to 6 months after final administration.
11) The patient has no severe dysfunction of major organs (bone marrow, liver, kidneys, heart, lungs, etc.) and the patient's laboratory results from up to 14 days prior to enrollment fall within the criteria
i) WBC <=12,000/mm^3
ii) Neutrophil >=1,500/mm^3
iii) Platelet >=100,000/mm^3
iv) Hemoglobin >=8.0g/dL
v) Total bilirubin <=1.5mg/dL
vi) AST, ALT <=100IU/L
vii) Albumin >=2.5g/dL
viii) Serum creatinine <=1.5mg/dL
ix) Creatinine clearance >=60mL/min

Exclude criteria

1) Serious drug-induced hypersensitivity (especially, platinum formulation, 5-FU, TFTD)
2) Patients received palliative operation (it is eligible at 28 days after the operation with the intestinal anastomosis, at 14 days after colostomy)
3) Patients with active infectious disorder
4) Patients with uncontrollable hypertension.
5) Patients with under treatment by continuous use of insulin or with complication of uncontrollable diabetes mellitus
6) Patients with cardiac disorder such as congestive heart failure, angina to need medication, transmural myocardial infarction definitely observed in ECG, clinically apparent valvular disease, symptomatic coronary disease, uncontrollable arrhythmia, anamnesis of myocardial infarction that developed within the past 12 months.
7) Patients with severe pulmonary disorder such as interstitial pneumonia, pulmonary fibrosis, severe emphysema.
8) Patients with mental disorder or with anamnesis of central nervous system disorder.
9) Patients who have the fresh bleeding from gastrointestinal tract needing a transfusion repeatedly.
10) Patients who are receiving anticoagulant.
11) Patients with watery stool (>=Grade2)
12) Active double cancer.
Synchronous double cancer and metachronous double cancer within a disease-free interval of 5 years. Lesions consistent with carcinoma in situ or intramucosal carcinoma that have been cured by local treatment are not classified as active multiple cancers.
13) Male patients with hope of pregnancy of his partner.
14) Patients with cirrhosis or active hepatitis.
15) Any other patients who are regarded as unsuitable for this study by the investigators

Related Information

• Primary Sponsor: Oki Eiji
• Source(s) of Monetary Support: Taiho Pharmaceutical Co., LTD