Bevacizumab Plus Fluorouracil and Leucovorin in Treating Patients With Locally Advanced or Metastatic Stage IV Colorectal Cancer That Has Progressed After Standard Chemotherapy

NCT00066846 | Completed Phase 2

• 2 other identifiers: CDR0000320506CTEP-TRC-0301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 33

Brief Summary

RATIONALE: Bevacizumab may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as fluorouracil and leucovorin use different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with fluorouracil and leucovorin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining bevacizumab with fluorouracil and leucovorin in treating patients who have locally advanced or metastatic stage IV colorectal cancer that has progressed after standard chemotherapy.

Conditions

Colorectal Cancer

Keywords

adenocarcinoma of the colon; adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage IV colon cancer; recurrent colon cancer

Interventions

bevacizumab BIOLOGICAL

fluorouracil DRUG

leucovorin calcium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed colorectal adenocarcinoma * Stage IV (metastatic) disease * Not curable by surgery or radiotherapy * Must have received prior standard chemotherapy regimens, including oxaliplatin and irinotecan, and meet both of the following criteria: * Disease progression during or after irinotecan-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant irinotecan-based therapy * Disease progression during or after oxaliplatin-based chemotherapy for metastatic disease OR relapsed disease within 6 months after adjuvant oxaliplatin-based therapy * No brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL (transfusion allowed) * No evidence of bleeding diathesis or coagulopathy Hepatic * Bilirubin no greater than 1.5 mg/dL * AST less than 5 times upper limit of normal (ULN) * Alkaline phosphatase less than 5 times ULN * PT and INR no greater than 1.5 times ULN * PTT no greater than ULN Renal * Creatinine no greater than 1.5 times ULN * Proteinuria less than grade 1 OR * Proteinuria less than 500 mg/24 hours Cardiovascular * No prior stroke * No uncontrolled high blood pressure * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart disease * No thromboembolism within the past 6 months Other * Chemonaive * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study participation * No significant traumatic injury within the past 6 weeks * No prior allergic reaction attributed to compounds of similar chemical or biological composition to bevacizumab or other study agents * No active infection * No psychiatric illness or social situation that would preclude study compliance * No serious nonhealing wound (including wounds healing by secondary intention), ulcer, or bone fracture * No CNS disease, including either of the following: * Primary brain tumor * Seizures not controlled with standard medical therapy PRIOR CONCURRENT THERAPY: Biologic therapy * At least 8 weeks since prior monoclonal antibody therapy * No prior bevacizumab Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy) Surgery * More than 6 weeks since prior major surgical procedure or open biopsy * More than 7 days since prior fine needle aspiration or core biopsy * No concurrent surgery Other * Recovered from prior therapy * At least 3 weeks since prior cytotoxic agents * No concurrent therapeutic anticoagulation * Prophylactic anticoagulation of venous access devices allowed provided PT/INR or PTT criteria are met * No concurrent chronic aspirin (greater than 325 mg/day) or nonsteroidal anti-inflammatory drugs * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational or commercial agents for the malignancy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (33)

Providence Alaska Medical Center

Anchorage, Alaska, 99519-6604, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90024, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

CCOP - Atlanta Regional

Atlanta, Georgia, 30342-1701, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242-1009, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Cancer Care of Maine

Bangor, Maine, 04401, United States

Location

Saint Joseph Mercy Health System

Ann Arbor, Michigan, 48106, United States

Location

St. Mary's/Duluth Clinic Cancer Center

Duluth, Minnesota, 55805, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Meritcare Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Sioux Valley Clinics - Oncology

Sioux Falls, South Dakota, 57104, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Chen HX, Mooney M, Boron M, Vena D, Mosby K, Grochow L, Jaffe C, Rubinstein L, Zwiebel J, Kaplan RS. Phase II multicenter trial of bevacizumab plus fluorouracil and leucovorin in patients with advanced refractory colorectal cancer: an NCI Treatment Referral Center Trial TRC-0301. J Clin Oncol. 2006 Jul 20;24(21):3354-60. doi: 10.1200/JCO.2005.05.1573.

  PMID: 16849749 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Helen X. Chen, MD

  NCI - Investigational Drug Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: August 1, 2003
• Study Completion: July 1, 2007
• Last Updated: June 20, 2013

Record last verified: 2004-04

Locations

US (33)