TriangleNCT00265850 · STUDY IN CONTEXT
Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.
PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.
Time to Treatment Failure
Duration of Tumor Response
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- trial label
- Cetuximab and/or Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 4
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0000
- source section id
- NCT00265850-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival
- endpoint definition
- Survival time will be defined as the time from registration to death. Time to event distributions will be estimated using the Kaplan-Meier method. Overall Survival (OS) will be compared between Arm A and Arm B.
- time origin
- Up to 5 years post-treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible KRAS wild type patients that began treatment were included in this endpoint.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0001
- source section id
- NCT00265850-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- PFS will be measured from study entry until first documented progression or death from any cause. Time to event distributions will be estimated using the Kaplan-Meier method. PFS will be compared between Arm A and Arm B.
- time origin
- Up to 5 years post-treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible KRAS wild type patients were included in this analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0002
- source section id
- NCT00265850-om-0002
- source outcome index
- 2
- endpoint
- Time to Treatment Failure
- endpoint definition
- Time to Treatment Failure
- time origin
- Up to 5 years post-treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible KRAS wild type patients that began treatment were included in this endpoint.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0003
- source section id
- NCT00265850-om-0003
- source outcome index
- 3
- endpoint
- Duration of Tumor Response
- endpoint definition
- Duration of Tumor Response
- time origin
- Up to 5 years post-treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Only patients that recorded a response were included in analysis
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A: FOLFOX or FOLFIRI + Bevacizumab
- regimen
- Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
- analyzed count
- 559
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00265850-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B: FOLFOX or FOLFIRI + Cetuximab
- regimen
- Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
- analyzed count
- 578
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00265850-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
- regimen
- Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00265850-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A: FOLFOX or FOLFIRI + Bevacizumab
- regimen
- Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
- analyzed count
- 559
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00265850-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B: FOLFOX or FOLFIRI + Cetuximab
- regimen
- Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
- analyzed count
- 578
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00265850-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Arm C: FOLFOX or FOLFIRI + Cetuximab + Bevacizumab
- regimen
- Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Also, patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00265850-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A: FOLFOX or FOLFIRI + Bevacizumab
- regimen
- Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
- analyzed count
- 559
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00265850-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B: FOLFOX or FOLFIRI + Cetuximab
- regimen
- Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
- analyzed count
- 578
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00265850-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A: FOLFOX or FOLFIRI + Bevacizumab
- regimen
- Patients receive bevacizumab 5 mg/kg IV every two weeks and then receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
- analyzed count
- 320
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00265850-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B: FOLFOX or FOLFIRI + Cetuximab
- regimen
- Patients receive cetuximab 400mg/m\^2 IV over 2 hours on the first day of treatment, then 250 mg/m\^2 IV over 1 hour weekly thereafter. Patients also receive either FOLFOX or FOLFIRI every two weeks as described in the intervention section. One cycle is defined as 8 weeks of treatment. Treatment continues until disease progression, unacceptable toxicity or surgery with curative intent as planned. FOLFOX or: Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours FOLFIRI: Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.
- analyzed count
- 368
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00265850-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- harm key
- EG000
- source section id
- NCT00265850-ae
- event group key
- EG000
- event group label
- Arm A: FOLFOX or FOLFIRI + Bevacizumab
- serious affected
- 98
- serious at risk
- 559
- other affected
- 531
- other at risk
- 559
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-colorectal-neoplasm
- nct id
- NCT00265850
- harm key
- EG001
- source section id
- NCT00265850-ae
- event group key
- EG001
- event group label
- Arm B: FOLFOX or FOLFIRI + Cetuximab
- serious affected
- 111
- serious at risk
- 578
- other affected
- 548
- other at risk
- 578
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Analysis was conducted on all KRAS wild type patients that were treated and assessed for adverse events.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice