Capecitabine Plus Aflibercept as Maintenance Therapy Following Capecitabine Plus Oxaliplatin Plus Aflibercept in Patients With Metastatic Colorectal Cancer (Drop and Go)
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|ClinicalTrials.gov Identifier: NCT02085005|
Recruitment Status : Withdrawn
First Posted : March 12, 2014
Last Update Posted : November 18, 2014
Efficacy: To assess the progression-free survival rate at 10 months in patients on maintenance therapy with capecitabine plus aflibercept.
- 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
To collect blood and tumor samples to perform investigations for potential biomarker testing.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic||Drug: Capecitabine Drug: Aflibercept AVE0005 Drug: Oxaliplatin SR96669||Phase 2|
Total study duration for a participant can be up to 28 months.
This trial is being conducted in countries where the INN designation for the study molecule is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US proper name is "ziv-aflibercept".
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
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
Pharmaceutical form:tablet Route of administration: oral
Drug: Aflibercept AVE0005
Pharmaceutical form:concentrate for infusion Route of administration: intravenous
Drug: Oxaliplatin SR96669
Pharmaceutical form:solution for infusion Route of administration: intravenous
- Progression Free Survival rate at 10 months (PFS@10m) [ Time Frame: every 9 weeks, up to 28 months ]
- Progression Free Survival (PFS) - Time [ Time Frame: every 9 weeks, up to 28 months ]
- Overall Survival (OS) - Time [ Time Frame: every 9 weeks, up to 28 months ]
- Assessment of Objective Response Rate (ORR) [ Time Frame: every 9 weeks, up to 28 months ]
- Total Score as a measure of Health Related Quality of Life [ Time Frame: every 3 weeks, up to end of treatment ]
- Number of participants with adverse events [ Time Frame: up to 30 days after last treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085005
|Study Director:||Clinical Sciences & Operations||Sanofi|