Trials / Completed
CompletedNCT01996306
A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC
A Multinational, Randomized, Phase III Study of XELIRI With/Without Bevacizumab Versus FOLFIRI With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 650 (actual)
- Sponsor
- Epidemiological and Clinical Research Information Network · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.
Detailed description
Primary endpoint: Overall survival (OS), Secondary endpoints: Progression-free survival (PFS), Time to treatment failure (TTF), Overall response rate (ORR),Disease Control Rate (DCR), Relative dose intensity, Safety, and Correlation between UGT1A1 genotype and Safety.
Conditions
- Colorectal Neoplasms
- Neoplasm Metastasis
- Intestinal Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Bevacizumab | 5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. |
| DRUG | CPT-11 (Irinotecan) | 150-180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle. |
| DRUG | 5-FU Bolus | 400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. |
| DRUG | 5-FU Infusion | 2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. |
| DRUG | l-LV (dl-LV) | 200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. |
| BIOLOGICAL | bevacizumab | 7.5mg/kg IV intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on Day 1 of a 3-week cycle. |
| DRUG | CPT-11 (Irinotecan) | 150-200 mg/m2 intravenously administered over 90 minutes on day 1 of a 3-week cycle. |
| DRUG | Capecitabine | 1600mg/m2/day oral on day 1 (evening) to day 15 (morning)of a 3-week cycle. |
Timeline
- Start date
- 2013-12-02
- Primary completion
- 2017-11-20
- Completion
- 2018-06-30
- First posted
- 2013-11-27
- Last updated
- 2019-01-08
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01996306. Inclusion in this directory is not an endorsement.