Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer

Sponsor
Tianshu Liu
Study ID
NCT02071069
Phase
PHASE2
Status
Unknown

Conditions

  • Incurable Colorectal Cancer
  • RAS-wild-type

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cetuximab — DRUG
    400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks
  • irinotecan — DRUG
    180 mg/m2 IV every 2 weeks
  • fluorouracil — DRUG
    400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks

Study Details

1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer. 2. The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months. This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy

Key Dates

Start date
Jul 31, 2013
Status verified
Nov 2015
Primary completion
May 31, 2016
Completion
Jul 31, 2016

Study Design

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

Arms

  • Experimental: maintenance therapy
    Initially, all subjects received 8 cycles of Cetuximab (400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks)plus FOLFIRI (irinotecan 180 mg/m2 IV on day 1 , leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks) . After 8 cycles or severe toxicity, patients received maintenance therapy comprising Cetuximab (250mg/m2 every week or 500mg/m2 every 2 weeks) and either irinotecan( 180 mg/m2 IV every 2 weeks) or fluorouracil arm( leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks ). In cases of unacceptable toxicity, only the related medication was stopped

Primary Outcome Measure

The progression free-survival [ Time Frame: 8 Months after the last subject participate in ]

Central Contacts