Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer
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ClinicalTrials.gov Identifier: NCT00112918 |
Recruitment Status
:
Completed
First Posted
: June 3, 2005
Results First Posted
: September 6, 2012
Last Update Posted
: August 27, 2013
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Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition: |
Colorectal Cancer |
Interventions: |
Biological: Bevacizumab Drug: Capecitabine Drug: 5-Fluorouracil (5-FU) Drug: Leucovorin calcium Drug: Oxaliplatin |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Randomization was stratified according to geographic region and disease stage (high-risk stage II or stage III N1 or stage III N2). The primary analysis population consisted of patients with Stage III disease. |
Reporting Groups
Description | |
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FOLFOX4 |
Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Observation only. |
FOLFOX4 + Bv |
Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
XELOX+Bv |
Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks). Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks). |
Participant Flow: Overall Study
FOLFOX4 | FOLFOX4 + Bv | XELOX+Bv | |
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STARTED | 1151 | 1155 | 1145 |
Received Treatment | 1126 | 1145 [1] | 1135 |
Stage III Disease Population | 955 | 960 | 952 |
COMPLETED | 854 [2] | 810 [2] | 846 [2] |
NOT COMPLETED | 297 | 345 | 299 |
[1] | Includes two patients from FOLFOX4 who received Bv and were assigned to FOLFOX4+Bv safety analysis |
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[2] | Represents patients alive in follow-up at the time of final data cut-off (30 June 2012) |

1. Primary: | Disease-free Survival in Stage III Cancer Patients - Time to Event [ Time Frame: From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). ] |
2. Primary: | Disease-free Survival in Stage III Cancer Patients - Number of Events [ Time Frame: From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). ] |
3. Secondary: | Overall Survival in Stage III Cancer Patients - Time to Event [ Time Frame: From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). ] |
4. Secondary: | Overall Survival in Stage III Cancer Patients - Number of Events [ Time Frame: From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). ] |
5. Secondary: | Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis [ Time Frame: From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). ] |
6. Secondary: | Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis [ Time Frame: From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). ] |

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
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Results Point of Contact:
Organization: Hoffman-LaRoche
phone: 800-821-8590
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00112918 History of Changes |
Other Study ID Numbers: |
CDR0000427299 P30CA016042 ( U.S. NIH Grant/Contract ) UCLA-0412086-01 ROCHE-BO17920A |
First Submitted: | June 2, 2005 |
First Posted: | June 3, 2005 |
Results First Submitted: | June 1, 2012 |
Results First Posted: | September 6, 2012 |
Last Update Posted: | August 27, 2013 |