TriangleNCT00700102 · CITED IN SOURCE DOCUMENTS
A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2015-07-30
This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Overall Survival: Time From Randomization to Death From Any Cause
Overall Survival: Months From Time of First Line Therapy
Participants With Progression Free Survival Event
Progression Free Survival: Time to Event
Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria
Response Rate: Participants With Response Status Based on RECIST Criteria
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Adult patients, \>=18 years of age * Metastatic colorectal cancer and disease progression * Previously treated with first-line chemotherapy plus Avastin * Eastern Cooperative Oncology Group (ECOG) performance status \<=2. Exclusion Criteria: * Diagnosis of progression of disease more than 3 months after last Avastin administration * First-line patients with progression-free survival in first-line of \<3 months * Patients receiving less than 3 consecutive months of Avastin in first-line therapy * Past or current history (within the last 2 years prior to treatment start) of other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix * Clinically significant cardiovascular disease within 6 months prior to start of study treatment * Known central nervous system (CNS) disease, except for treated CNS metastases as defined by protocol
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Chemotherapy alone until disease progression, unacceptable toxicity, or patient refusal
- intervention Names
- Drug: Chemotherapy
- label
- Chemotherapy
- type
- ACTIVE_COMPARATOR
- description
- Chemotherapy and Bevacizumab until disease progression, unacceptable toxicity, or patient refusal
- intervention Names
- Drug: Chemotherapy
- Drug: Bevacizumab
- label
- Chemotherapy + Bevacizumab
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Chemotherapy
- Chemotherapy + Bevacizumab
- description
- As prescribed
- name
- Chemotherapy
- type
- DRUG
- arm Group Labels
- Chemotherapy + Bevacizumab
- description
- Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.
- name
- Bevacizumab
- other Names
- Avastin
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 820
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Overall Survival: Time From Randomization to Death From Any Cause
- time Frame
- within 6.5 years
- secondary Outcomes
- measure
- Overall Survival: Months From Time of First Line Therapy
- time Frame
- within approximately 9.6 years
- measure
- Participants With Progression Free Survival Event
- time Frame
- within 6.5 years
- measure
- Progression Free Survival: Time to Event
- time Frame
- within 6.5 years
- measure
- Response Rate: Percentage of Participants With Best Overall Response, Defined as Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST Criteria
- time Frame
- within 6.5 years
- description
- Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment.
- measure
- Response Rate: Participants With Response Status Based on RECIST Criteria
- time Frame
- within 6.5 years
Full study description
- brief Summary
- This study will evaluate the efficacy and safety of adding bevacizumab to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus bevacizumab. Participants will receive chemotherapy alone, or in combination with bevacizumab. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after stopping chemotherapy.
Source references
- references
- citation
- Li Y, Hu M, Zhang Z, Chu M, Xu R, Liu L, Dong W, Yang M, Zhang R. Cost-effectiveness analysis of continuing bevacizumab plus chemotherapy versus chemotherapy alone after first progression of metastatic colorectal cancer. Cancer Med. 2024 Jan;13(1):e6904. doi: 10.1002/cam4.6904. Epub 2024 Jan 8.
- pmid
- 38186268
- type
- DERIVED
- citation
- Kubicka S, Greil R, Andre T, Bennouna J, Sastre J, Van Cutsem E, von Moos R, Osterlund P, Reyes-Rivera I, Muller T, Makrutzki M, Arnold D; ML18147 study investigators including AIO, GERCOR, FFCD, UNICANCER GI, TTD, BGDO, GEMCAD, and AGMT groups. Bevacizumab plus chemotherapy continued beyond first progression in patients with metastatic colorectal cancer previously treated with bevacizumab plus chemotherapy: ML18147 study KRAS subgroup findings. Ann Oncol. 2013 Sep;24(9):2342-9. doi: 10.1093/annonc/mdt231. Epub 2013 Jul 12.
- pmid
- 23852309
- type
- DERIVED
- citation
- Bennouna J, Sastre J, Arnold D, Osterlund P, Greil R, Van Cutsem E, von Moos R, Vieitez JM, Bouche O, Borg C, Steffens CC, Alonso-Orduna V, Schlichting C, Reyes-Rivera I, Bendahmane B, Andre T, Kubicka S; ML18147 Study Investigators. Continuation of bevacizumab after first progression in metastatic colorectal cancer (ML18147): a randomised phase 3 trial. Lancet Oncol. 2013 Jan;14(1):29-37. doi: 10.1016/S1470-2045(12)70477-1. Epub 2012 Nov 16.
- pmid
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- type
- DERIVED
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