Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer (STEAM)
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ClinicalTrials.gov Identifier: NCT01765582 |
Recruitment Status :
Terminated
First Posted : January 10, 2013
Results First Posted : September 18, 2017
Last Update Posted : September 18, 2017
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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 Neoplasms |
Interventions |
Drug: 5-fluorouracil Drug: bevacizumab Drug: capecitabine Drug: irinotecan Drug: folinic acid Drug: oxaliplatin |
Enrollment | 280 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Arm A: Concurrent FOLFOXIRI + Bevacizumab | Arm B: Sequential FOLFOXIRI + Bevacizumab | Arm C: FOLFOX + Bevacizumab |
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Arm/Group Description | Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. | Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. |
Period Title: Overall Study | |||
Started | 93 | 92 | 95 |
Completed | 0 | 0 | 0 |
Not Completed | 93 | 92 | 95 |
Reason Not Completed | |||
Other | 3 | 6 | 9 |
Lost to Follow-up | 2 | 2 | 1 |
Death | 31 | 36 | 33 |
Sponsor Decision | 46 | 42 | 42 |
Withdrawal of Consent | 11 | 6 | 10 |
Baseline Characteristics
Arm/Group Title | Arm A: Concurrent FOLFOXIRI + Bevacizumab | Arm B: Sequential FOLFOXIRI + Bevacizumab | Arm C: FOLFOX + Bevacizumab | Total | |
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Arm/Group Description | Participants received concurrent FOLFOXIRI along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4 month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-fluorouracil (5-FU) with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. | Participants received alternating 4-week administrations of FOLFOX/bevacizumab and folinic acid (leucovorin), 5-FU, and irinotecan (FOLFIRI) /Bevacizumab with a treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. | Participants received FOLFOX along with 5 mg/kg of bevacizumab with treatment cycle of 2 weeks during first 4-month induction phase (plus optional 2 months of induction for participants who exhibited good response and tolerated the regimen) followed by administration of 5-FU with bevacizumab or capecitabine with bevacizumab as per investigator's discretion in maintenance phase. Following progression on first-line therapy (PD1), bevacizumab (dose equivalent, 2.5 mg/kg/week) was administered as second-line therapy in combination with fluoropyrimidine based chemotherapy at the investigator's discretion. | Total of all reporting groups | |
Overall Number of Baseline Participants | 93 | 92 | 95 | 280 | |
Baseline Analysis Population Description |
Intent to Treat (ITT) population was defined as all randomized participants regardless of whether they received any dose of study treatment.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 93 participants | 92 participants | 95 participants | 280 participants | |
56.0 (11.53) | 56.0 (10.46) | 57.9 (9.86) | 56.7 (10.63) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 93 participants | 92 participants | 95 participants | 280 participants | |
Female |
42 45.2%
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40 43.5%
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36 37.9%
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118 42.1%
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Male |
51 54.8%
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52 56.5%
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59 62.1%
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162 57.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
This trial was terminated on 12 November 2015, because the primary objective was not met.
More Information
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: | Medical Communications |
Organization: | Hoffmann-La Roche |
Phone: | 800-821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01765582 |
Other Study ID Numbers: |
ML28442 |
First Submitted: | January 9, 2013 |
First Posted: | January 10, 2013 |
Results First Submitted: | June 2, 2017 |
Results First Posted: | September 18, 2017 |
Last Update Posted: | September 18, 2017 |