Capecitabine Plus Aflibercept as Maintenance Therapy Following Capecitabine Plus Oxaliplatin Plus Aflibercept in Patients With Metastatic Colorectal Cancer

Sponsor
Sanofi
Study ID
NCT02085005
Phase
PHASE2
Status
Withdrawn

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • Capecitabine — DRUG
    Pharmaceutical form:tablet Route of administration: oral
  • Aflibercept AVE0005 — DRUG
    Pharmaceutical form:concentrate for infusion Route of administration: intravenous
  • Oxaliplatin SR96669 — DRUG
    Pharmaceutical form:solution for infusion Route of administration: intravenous

Study Details

Primary Objective: Efficacy: To assess the progression-free survival rate at 10 months in patients on maintenance therapy with capecitabine plus aflibercept. Secondary Objectives: To evaluate: * Efficacy: Progression Free Survival (PFS) * Efficacy: Overall Survival (OS) * Efficacy: Objective Response Rate (ORR) as per Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria * Health related Quality of Life (HRQL): EORTC QLQ-C30 scores and EQ5D-3L * Safety Exploratory Objective: To collect blood and tumor samples to perform investigations for potential biomarker testing.

Key Dates

Start date
Mar 31, 2014
Status verified
Nov 2014
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

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

Arms

  • Experimental: Aflibercept
    Intravenous (IV) infusion on Day 1 every 3 weeks, followed by CAPOX (capecitabine by oral administration on Day 1 to Day 14 and oxaliplatin intravenous (IV) infusion on Day 1 every 3 weeks) for the induction treatment period (6 cycles) after which the patient may enter the maintenance period during which the treatment is Aflibercept + Capecitabine

Primary Outcome Measure

Progression Free Survival rate at 10 months (PFS@10m) [ Time Frame: every 9 weeks, up to 28 months ]

Related Studies