Phase I Study of Biweekly SIRB Regimen for Metastatic Colorectal Cancer

Sponsor
Fujian Cancer Hospital
Study ID
NCT03380689
Phase
PHASE1
Status
Withdrawn

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • S-1 — DRUG
    \- S-1 is administered orally on days 1 to 7 of a 14-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA \<1.25m2), 50 mg (BSA \>1.25 to \<1.50 m2), or 60 mg (BSA \>1.50 m2).
  • Irinotecan — DRUG
    \- CPT-11 was administrated as a 90-min intravenous infusion on day 1 of a 14-day cycle. Five escalating dose levels of CPT-11 were prepared, at an initial dose of 75mg/m2/day (level 1), stepping up to 100 (level 2), 125 (level 3), 150 (level 4) or 175 (level 5) mg/m2/day.
  • Bevacizumab — DRUG
    \- Bevacizumab (5 mg/kg) is administered by intravenous infusion over the course of 30 to 90 min on day 1 of each 2-week cycle.

Study Details

Phase I Study of biweekly combination therapy with S-1, Irinotecan, and Bevacizumab as 1-line Chemotherapy in Patients With Advanced Colorectal Cancer.

Key Dates

Start date
Jan 5, 2018
Status verified
Dec 2017
Primary completion
Jul 5, 2018
Completion
Jan 5, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SIRB2
    Biweekly combination therapy with S-1, Irinotecan, and Bevacizumab

Primary Outcome Measure

Maximum tolerance dose [ Time Frame: From enrollment to completion of study. Estimated about 12 months. ]

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