A Phase 2 interventional study of sorafenib tosylate and bevacizumab in Recurrent Colon Cancer, Recurrent Rectal Cancer and Stage IV Colon Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 211 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment
This phase II trial is studying how well giving sorafenib together with bevacizumab works in treating patients with metastatic colorectal cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib and bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells
PRIMARY OBJECTIVES:
I. Evaluate proportion of patients who are progression-free at 3 months (in historic comparison with results for single-agent bevacizumab in ECOG 3200).
SECONDARY OBJECTIVES:
I. Response rate (RR) II. Overall survival (OS) III. Safety IV. Feasibility
OUTLINE: This is a multicenter study.
Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies.
After completion of study treatment, patients are followed periodically for up to 2 years.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 83 is close to the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Measurable disease
No known brain metastasis
No concurrent uncontrolled illness including, but not limited to, any of the following:
No serious, non-healing wound, active ulcer, or untreated bone fracture
None of the following within the past 6 months:
No other active malignancy within the past 3 years except non melanoma skin cancer or carcinoma in situ of the cervix
Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies
Drug: sorafenib tosylate · Biological: bevacizumab
Given orally
Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN
Given IV
Also known as: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, Avastin, rhuMAb VEGF
Progression-free Survival Rate
The primary endpoint of this trial is progression free survival at 3 months. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be considered evaluable. Patients lost to follow-up before 3 months (e.g., progression, refusing further treatment, etc.) will be considered treatment failures. All eligible patients will be followed until death or a minimum of 3 years. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Progression is defined as at least a 20% increase in the sum of longest liameter of target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Time frame: At 3 months
Response Rate
Number of patients reporting a partial response or complete response while on treatment
Time frame: 2 years
Overall Survival
The distribution of overall survival will be estimated using Kaplan-Meier methodology.
Time frame: 2 years
Feasibility of Study Treatment
Will be evaluated based on the number of patients who delayed treatment, omitted doses of treatment, or reduced treatment dose.
Time frame: 2 years
83 patients were registered between 06/03/2009 and 10/20/2009 from 25 North Central Cancer Treatment Group (NCCTG) sites.
| Milestone | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| Started | 83 |
| Completed | 79 |
| Not completed | 4 |
| Withdrew: Ineligible | 3 |
| Withdrew: Withdrawal by subject | 1 |
The primary endpoint of this trial is progression free survival at 3 months. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be considered evaluable. Patients lost to follow-up before 3 months (e.g., progression, refusing further treatment, etc.) will be considered treatment failures. All eligible patients will be followed until death or a minimum of 3 years. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Progression is defined as at least a 20% increase in the sum of longest liameter of target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
| percentage of participants | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| Progression-free Survival Rate | 53.2 (41.7 to 64.4) |
Number of patients reporting a partial response or complete response while on treatment
| Participants | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| Response Rate | 1 |
The distribution of overall survival will be estimated using Kaplan-Meier methodology.
| months | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| Overall Survival | 8.3 (5.5 to 11.3) |
Will be evaluated based on the number of patients who delayed treatment, omitted doses of treatment, or reduced treatment dose.
| Participants | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| Delayed treatment at least once | 31 |
| Omitted a dose of BEV at least once | 13 |
| Omitted a dose of sorafenib at least once | 26 |
| Reduced sorafenib at least once | 49 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Sorafenib Tosylate and Bevacizumab) | — | 13/79 (16.5%) | 78/79 (98.7%) |
| Event | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| HypertensionVascular disorders | 3/79 |
| DiarrheaGastrointestinal disorders | 2/79 |
| Creatinine increasedInvestigations | 2/79 |
| Lipase increasedInvestigations | 2/79 |
| Hemoglobin decreasedBlood and lymphatic system disorders | 1/79 |
| Abdominal painGastrointestinal disorders | 1/79 |
| Esophageal varices hemorrhageGastrointestinal disorders | 1/79 |
| IleusGastrointestinal disorders | 1/79 |
| NauseaGastrointestinal disorders | 1/79 |
| Rectal fistulaGastrointestinal disorders | 1/79 |
| Event | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| FatigueGeneral disorders | 74/79 |
| AnorexiaMetabolism and nutrition disorders | 58/79 |
| DiarrheaGastrointestinal disorders | 49/79 |
| Weight lossInvestigations | 45/79 |
| HypertensionVascular disorders | 43/79 |
| Protein urine positiveRenal and urinary disorders | 40/79 |
| Hand-and-foot syndromeSkin and subcutaneous tissue disorders | 38/79 |
| Abdominal painGastrointestinal disorders | 37/79 |
| NauseaGastrointestinal disorders | 37/79 |
| Rash desquamatingSkin and subcutaneous tissue disorders | 24/79 |
| Age, Continuous(years) | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| Median | 62 (36 to 88) |
| Sex: Female, Male(Participants) | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| Female | 36 |
| Male | 43 |
| Performance Score(participants) | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| 0 (Fully active) | 44 |
| 1 (Restricted in physically strenuous activity) | 35 |
| Kirsten rat sarcoma (KRAS)(participants) | Treatment (Sorafenib Tosylate and Bevacizumab) |
|---|---|
| Wild-type | 39 |
| Mutated | 40 |
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Alliance for Clinical Trials in Oncology