Phase II Study of First-line Capecitabine Plus Oxaliplatin Plus Aflibercept for 6 Cycles Followed by Capecitabine Plus Aflibercept as Maintenance Therapy in Patients With Metastatic Colorectal Cancer: DROP and GO Trial (Drop and Go)

NCT02085005 Phase 2 WITHDRAWN

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.

Details

Lead sponsor	Sanofi
Phase	Phase 2
Status	WITHDRAWN
Start date	2014-03
Completion	2016-08

Conditions

• Colorectal Cancer Metastatic

Interventions

• Capecitabine
• Aflibercept AVE0005
• Oxaliplatin SR96669

Primary outcomes

• Progression Free Survival rate at 10 months (PFS@10m) — every 9 weeks, up to 28 months