Irinotecan Plus Raltitrexed as Second-line Treatment in Advanced Colorectal Cancer Patients

Sponsor
China Medical University, China
Study ID
NCT03053167
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    Irinotecan: 180mg/㎡+NS250ml, ivgtt, 90min, d1 Every 3 weeks
  • Raltitrexed — DRUG
    Raltitrexed: 3mg/㎡+NS100ml，ivgtt，15min, d1 Every 3 weeks

Study Details

Irinotecan and raltitrexed are active against advanced colorectal cancer (ACC), act through different mechanisms, and have only partially overlapping toxicity profiles. The purpose of this study is to evaluate efficacy and safety of irinotecan plus raltitrexed as second-line treatment in advanced colorectal cancer patients.

Key Dates

Start date
Dec 31, 2016
Status verified
Feb 2017
Primary completion
Dec 31, 2019
Completion
Dec 31, 2020

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan & Raltitrexed
    advanced colorectal cancer patients treated with irinotecan plus raltitrexed as second-line treatment. Irinotecan:180mg/㎡+NS250ml, ivgtt, 90min, d1 Raltitrexed: 3mg/㎡+NS100ml，ivgtt，15min, d1 Every 3 weeks

Primary Outcome Measure

Progression Free Survival [PFS] [ Time Frame: 5-6 months ]

Central Contacts

Related Studies