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Sorafenib and Bevacizumab in ...

Sorafenib and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Last Updated: 2026-01-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-02-28

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Recurrent Colon Cancer Recurrent Rectal Cancer Stage IV Colon Cancer Stage IV Rectal Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (sorafenib tosylate and bevacizumab)

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

Group Type EXPERIMENTAL

sorafenib tosylate

Intervention Type DRUG

Given orally

bevacizumab

Intervention Type BIOLOGICAL

Given IV

Interventions

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sorafenib tosylate

Given orally

Intervention Type DRUG

bevacizumab

Given IV

Intervention Type BIOLOGICAL

Other Intervention Names

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BAY 43-9006 BAY 43-9006 Tosylate Salt BAY 54-9085 Nexavar SFN anti-VEGF humanized monoclonal antibody anti-VEGF monoclonal antibody Avastin rhuMAb VEGF

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of stage IV colorectal cancer (histologic proof is not required)
* Measurable disease

* Spiral CT scan required for both pre- and post-treatment tumor assessments of lesions measuring 1-2 cm
* Progressive disease during or within 6 months of most recent prior chemotherapy regimen (bevacizumab, fluoropyrimidine, oxaliplatin, or irinotecan-based treatment) OR considered ineligible for standard therapy
* Documentation of submission of tumor material for Kirsten Rat Sarcoma (KRAS) testing available
* Prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab or panitumumab) required for patients with wild-type KRAS tumor
* No known brain metastasis

* Patients with neurological symptoms must undergo a CT scan or MRI of the brain to exclude brain metastasis
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Life expectancy ≥ 6 months
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count (ANC) ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* White blood cell count (WBC) ≥ 3,400/mm³
* International normalized ratio (INR) \< 1.5 (≤ 3.0 if on anti-coagulation therapy \[e.g., warfarin or heparin\])
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 times ULN (≤ 5 times ULN if there is liver involvement)
* Alkaline phosphatase ≤ 3 times ULN
* Creatinine ≤ 1.5 times ULN
* Urine protein:creatinine ratio \< 1 OR urine dipstick \< 2+ OR urine protein \< 1,000 mg by 24-hour urine collection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment (≥ 2 weeks after completion of treatment with sorafenib tosylate alone)
* Willing to provide mandatory blood samples for translational research studies
* Able to swallow whole pills
* No inadequately controlled hypertension (i.e., systolic BP \> 150 mm Hg or diastolic BP \> 100 mm Hg on anti-hypertensive medications)
* No prior hypertensive crisis or hypertensive encephalopathy
* No myocardial infarction or unstable angina within the past 6 months
* No congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months
* No hemorrhage or bleeding event \> grade 3 within the past 4 weeks
* No evidence or history of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
* No greater than normal risk of bleeding
* No active or recent hemoptysis (≥ ½ teaspoon of bright red blood per episode) within the past 30 days
* No concurrent uncontrolled illness including, but not limited to, any of the following:

* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia requiring anti-arrhythmic drugs
* Psychiatric illness or social situations that would limit compliance with study requirements
* No known HIV infection or chronic hepatitis B or C infection
* No serious, non-healing wound, active ulcer, or untreated bone fracture

* Patients with fractures secondary to metastatic disease are eligible after appropriate radiotherapy
* No significant traumatic injury within the past 4 weeks
* No known or suspected allergy or hypersensitivity to any component of bevacizumab, sorafenib tosylate, or their excipients or to any other agent given in the course of this study
* No malabsorption problem
* None of the following within the past 6 months:

* Significant vascular disease (e.g., aortic aneurysm or aortic dissection)
* Peripheral arterial thrombosis
* Symptomatic peripheral vascular disease
* Abdominal fistula
* Gastrointestinal perforation
* Intra-abdominal abscess
* No other active malignancy within the past 3 years except non melanoma skin cancer or carcinoma in situ of the cervix

* Prior malignancy allowed provided patient is not receiving other specific treatment for that malignancy (other than hormonal therapy)
* No other concurrent investigational agent for this cancer
* Prior radiotherapy allowed
* No prior sorafenib tosylate
* No prior discontinuation of bevacizumab due to adverse events
* More than 4 weeks since prior and no concurrent participation in any other experimental drug study
* More than 4 weeks since prior St. John's wort or rifampin
* More than 4 weeks since prior and no concurrent major surgical procedure or open biopsy
* More than 7 days since prior core biopsy or minor surgical procedure, including placement of a vascular access device
* No concurrent anticoagulant, except low-dose warfarin or heparin for deep venous thrombosis prophylaxis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Axel Grothey, MD

Role: STUDY_CHAIR

North Central Cancer Treatment Group

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Saint Anthony Central Hospital

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Colorado Cancer Research Program CCOP

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Saint Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital Association

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Mcdonough District Hospital

Macomb, Illinois, United States

Site Status

Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Porubcin, Michael MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Sharis, Christine M MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Stoffel, Thomas J MD (UIA Investigator)

Moline, Illinois, United States

Site Status

Holy Family Medical Center

Monmouth, Illinois, United States

Site Status

Bromenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center Foundation

Normal, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Ottawa Regional Hospital and Healthcare Center

Ottawa, Illinois, United States

Site Status

Pekin Cancer Treatment Center

Pekin, Illinois, United States

Site Status

Pekin Hospital

Pekin, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Illinois Oncology Research Association CCOP

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Saint Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Saint Francis Hospital and Health Centers

Beech Grove, Indiana, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Community Howard Regional Health

Kokomo, Indiana, United States

Site Status

Indiana University Health La Porte Hospital

La Porte, Indiana, United States

Site Status

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, United States

Site Status

Reid Hospital and Health Care Services

Richmond, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

Site Status

South Bend Clinic

South Bend, Indiana, United States

Site Status

Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

Site Status

Cedar Rapids Oncology Association

Cedar Rapids, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status