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Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery

Last Updated: 2024-03-21

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2012-12-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Bevacizumab may also stop the growth of colon cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colon cancer that cannot be removed by surgery.

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Detailed Description

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OBJECTIVES:

Primary

* Determine the rate of major morbidity in patients with unresectable stage IV colon cancer and a synchronous asymptomatic primary tumor treated with fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX6) in combination with bevacizumab without resection of the primary tumor.

Secondary

* Determine the rate of specific events related to the intact primary tumor requiring hospitalization or a major intervention but not requiring surgery.
* Determine the rate of ≥ grade 3 toxicity as defined by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) that is related to study therapy prior to disease progression.
* Determine overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV given concurrently with leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years after study entry.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.

Conditions

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Colorectal 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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Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab

Group Type EXPERIMENTAL

bevacizumab

Intervention Type BIOLOGICAL

bevacizumab 5 mg/kg IV on day 1 every 14 days until excessive toxicity or disease progression

fluorouracil

Intervention Type DRUG

5-FU 400 mg/m2 IV bolus over 2-4 minutes then 2400 mg/m2 IV continuous infusion over 46 hours on day 1 every 14 days until excessive toxicity or disease progression

leucovorin

Intervention Type DRUG

leucovorin 400 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression

oxaliplatin

Intervention Type DRUG

Oxaliplatin 85 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression

Interventions

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bevacizumab

bevacizumab 5 mg/kg IV on day 1 every 14 days until excessive toxicity or disease progression

Intervention Type BIOLOGICAL

fluorouracil

5-FU 400 mg/m2 IV bolus over 2-4 minutes then 2400 mg/m2 IV continuous infusion over 46 hours on day 1 every 14 days until excessive toxicity or disease progression

Intervention Type DRUG

leucovorin

leucovorin 400 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression

Intervention Type DRUG

oxaliplatin

Oxaliplatin 85 mg/m2 IV on day 1 every 14 days until excessive toxicity or disease progression

Intervention Type DRUG

Other Intervention Names

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5-FU leucovorin calcium

Eligibility Criteria

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Inclusion Criteria

* Unresected primary tumor of the colon AND radiographically confirmed metastatic colon cancer (single or multiple sites of metastases) that are not considered surgically resectable for cure by chest imaging and CT scan or MRI of the abdomen within the past 4 weeks and by endoscopy within the past 8 weeks
* Asymptomatic primary tumor

* No obstruction, perforation, or active bleeding requiring transfusion
* Distal extent of the tumor must be ≥ 12 cm from the anal verge on endoscopy
* Not a candidate for curative surgical resection of all metastatic and colon primary tumors
* No evidence of Central Nervous System (CNS) metastases
* No recurrent local or metastatic disease after prior adjuvant therapy
* No diagnosis of rectal carcinoma

PATIENT CHARACTERISTICS:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Absolute neutrophil count ≥ 1200/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9 g/dL
* Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if liver metastases are present)
* Alkaline phosphatase ≤ 3.0 times ULN (≤ 5.0 times ULN if liver metastases are present)
* Bilirubin ≤ 1.5 times ULN (≤ 2.0 times ULN if liver metastases are present)
* Creatinine \< 1.8 mg/dL
* Urine dipstick indicating 0-1+ protein

* If dipstick reading is ≥ 2+, a 24-hour urine collection must demonstrate \< 1 g of protein
* Prothrombin Time and International Normalized Ratio (PT/INR) ≤ 1.5 unless the patient is on therapeutic doses of warfarin, in which case the following criteria must be met:

* Patient must have an in-range INR (between 2 and 3) on a stable dose of warfarin
* Patient must not have active bleeding or a pathologic condition that is associated with a high risk of bleeding
* Patients with a history of non-colorectal malignancies must be disease free for ≥ 5 years prior to study entry and be deemed at low risk for recurrence
* Patients with the following cancers are eligible if diagnosed and treated within the past 5 years:

* Carcinoma in situ of the colon
* Melanoma in situ
* Basal cell or squamous cell carcinoma of the skin
* Carcinoma in situ of the cervix
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after the completion of study therapy
* No uncontrolled blood pressure (BP), defined as BP \> 150/100 mm Hg
* No nonmalignant systemic disease that would preclude any of the study therapy drugs, compromise the safety of the patient, or inhibit the patient's ability to participate in the study, including any of the following:

* New York Heart Association class III or IV cardiac disease
* Myocardial infarction within the past 6 months
* Unstable angina within the past 6 months
* Symptomatic arrhythmia
* No transient ischemic attack or cerebrovascular accident within the past 6 months
* No symptomatic peripheral vascular ischemia within the past 6 months
* No arterial thrombotic event within the past 6 months
* No gastroduodenal ulcer(s) determined by endoscopy to be active
* No gastrointestinal perforation within the past 12 months
* No serious or nonhealing wound, skin ulcer, or bone fracture
* No significant traumatic injury within the past 28 days
* No significant episodes of acute bleeding requiring blood transfusion within the past 6 months
* No clinically significant (≥ grade 2) peripheral neuropathy (neurosensory or neuromotor toxicity)
* No pulmonary fibrosis or interstitial pneumonitis by chest x-ray
* No psychiatric or addictive disorders or other conditions that would preclude the patient from meeting study requirements

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior systemic chemotherapy, radiation therapy, or surgery for this malignancy
* No prior endoscopic management of this malignancy other than biopsy, including endoscopic stent placement, fulguration, or laser treatment
* More than 30 days since prior investigational drugs
* More than 28 days since prior major surgical procedure or open biopsy
* More than 7 days since prior core biopsy or other minor procedure, excluding placement of a vascular access device
* No concurrent major surgery unrelated to intact primary colon cancer
* No concurrent radiotherapy
* No concurrent filgrastim (G-CSF) or pegfilgrastim as primary prophylaxis for neutropenia
* No concurrent halogenated antiviral agents
* No other concurrent investigational drugs
* No other concurrent antineoplastic agents

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Norman Wolmark, MD

Role: PRINCIPAL_INVESTIGATOR

NSABP Foundation Inc

Locations

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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Site Status

Kaiser Permanente - Fremont

Fremont, California, United States

Site Status

Kaiser Permanente Medical Center - Hayward

Hayward, California, United States

Site Status

Scripps Cancer Center - San Diego

La Jolla, California, United States

Site Status

Kaiser Permanente Medical Center - Oakland

Oakland, California, United States

Site Status

Kaiser Permanente Medical Center - Redwood City

Redwood City, California, United States

Site Status

Kaiser Permanente Medical Center - Richmond

Richmond, California, United States

Site Status

Kaiser Permanente Medical Center - Roseville

Roseville, California, United States

Site Status

South Sacramento Kaiser-Permanente Medical Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Center - Sacramento

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, United States

Site Status

Kaiser Permanente Medical Center - San Francisco Geary Campus

San Francisco, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Teresa

San Jose, California, United States

Site Status

Kaiser Foundation Hospital - San Rafael

San Rafael, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara Kiely Campus

Santa Clara, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Rosa

Santa Rosa, California, United States

Site Status

Kaiser Permanente Medical Center - South San Francisco

South San Francisco, California, United States

Site Status

Kaiser Permanente Medical Facility - Stockton

Stockton, California, United States

Site Status

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

Site Status

Kaiser Permanente Medical Center - Walnut Creek

Walnut Creek, California, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Site Status

Lakeland Regional Cancer Center at Lakeland Regional Medical Center

Lakeland, Florida, United States

Site Status

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Advocate Lutheran General Cancer Care Center

Park Ridge, Illinois, United States

Site Status

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Howard Community Hospital

Kokomo, Indiana, United States

Site Status

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Site Status

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Saint Joseph Regional Medical Center

South Bend, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status

McCreery Cancer Center at Ottumwa Regional

Ottumwa, Iowa, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status