Clinical trial · Interventional
Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer
A Randomized, Phase 2B Study Of Sunitinib Plus Oxaliplatin, 5-Fluorouracil And Leucovorin (FOLFOX) Versus Bevacizumab Plus FOLFOX As First-Line Treatment In Patients With Metastatic Colorectal Cancer
NCT00609622CI-TRIAL-00008256terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): See termination reason in detailed description.
Summary
Brief summary (as posted)
This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| mFOLFOX6 | Drug | — | UNRESOLVED |
| sunitinib | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Treatment arm A - sunitinib plus mFOLFOX6
- interventionNames
- Drug: sunitinib
- Drug: mFOLFOX6
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Treatment arm B - bevacizumab plus mFOLFOX6
- interventionNames
- Drug: bevacizumab
- Drug: mFOLFOX6
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adenocarcinoma of the colon or rectum with locally advanced or metastatic disease * Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) * Eastern Cooperative Oncology Group (ECOG) 0 or 1 Exclusion Criteria: * Previous treatment with Sutent, Avastin, or any other systemic therapy for locally advanced or metastatic colorectal cancer * Less than 6 months since completion of adjuvant chemotherapy to documentation of recurrent disease * History of cardiac disease * Brain mets
References
Publications (2)
- DERIVEDBreen DM, Kim H, Bennett D, Calle RA, Collins S, Esquejo RM, He T, Joaquim S, Joyce A, Lambert M, Lin L, Pettersen B, Qiao S, Rossulek M, Weber G, Wu Z, Zhang BB, Birnbaum MJ. GDF-15 Neutralization Alleviates Platinum-Based Chemotherapy-Induced Emesis, Anorexia, and Weight Loss in Mice and Nonhuman Primates. Cell Metab. 2020 Dec 1;32(6):938-950.e6. doi: 10.1016/j.cmet.2020.10.023. Epub 2020 Nov 17. PMID 33207247
- DERIVEDHecht JR, Mitchell EP, Yoshino T, Welslau M, Lin X, Chow Maneval E, Paolini J, Lechuga MJ, Kretzschmar A. 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus sunitinib or bevacizumab as first-line treatment for metastatic colorectal cancer: a randomized Phase IIb study. Cancer Manag Res. 2015 Jun 15;7:165-73. doi: 10.2147/CMAR.S61408. eCollection 2015. PMID 26109878