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A Multicenter Study of the Anti-VEGF Monoclonal Antibody Bevacizumab (AvastinĀ®) Plus 5-Fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancers That Have Progressed After Standard Chemotherapy

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

A Multicenter Study of the Anti-VEGF Monoclonal Antibody Bevacizumab (AvastinĀ®) Plus 5-Fluorouracil/Leucovorin in Patients With Metastatic Colorectal Cancers That Have Progressed After Standard Chemotherapy


- Determine the response rate of patients treated with bevacizumab, fluorouracil, and
leucovorin calcium for stage IV colorectal cancer that has progressed after standard

- Determine the time to progression and overall survival of patients treated with this

- Determine the safety of administering "bolus" and continuous infusion fluorouracil and
leucovorin calcium in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study. Patients receive 1 of 2 treatment

- Regimen I: Patients receive bevacizumab IV on days 1, 15, 29, and 42 (every 2 weeks)
and leucovorin calcium (CF) IV over 2 hours and fluorouracil (5-FU) IV bolus on days 1,
8, 15, 22, 29, and 36.

- Regimen II: Patients receive bevacizumab as in regimen I and CF IV over 2 hours and
5-FU IV bolus followed by a continuous infusion over 22 hours on days 1, 2, 15, 16, 29,
30, 43, and 44.

For both regimens, courses repeat every 8 weeks in the absence of disease progression or
unacceptable toxicity.

Patients are followed for tumor response and survival.

PROJECTED ACCRUAL: Various NCI-designated Clinical Cancer Centers and other medical
institutions across the United States will participate in this study. A total of 35-125
patients will be accrued for this study within 3 months.

Inclusion Criteria


- 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

- 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



- 18 and over

Performance status

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy

- Not specified


- 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


- 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


- Creatinine no greater than 1.5 times ULN

- Proteinuria less than grade 1 OR

- Proteinuria less than 500 mg/24 hours


- 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


- 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


Biologic therapy

- At least 8 weeks since prior monoclonal antibody therapy

- No prior bevacizumab


- See Disease Characteristics

Endocrine therapy

- Not specified


- At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative


- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Helen X. Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Investigational Drug Branch


United States: Federal Government

Study ID:




Start Date:

August 2003

Completion Date:

July 2007

Related Keywords:

  • Colorectal Cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • stage IV rectal cancer
  • recurrent rectal cancer
  • stage IV colon cancer
  • recurrent colon cancer
  • Colorectal Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Ireland Cancer Center Cleveland, Ohio  44106-5065
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Loyola University Medical Center Maywood, Illinois  60153
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Lombardi Cancer Center Washington, District of Columbia  20007
CCOP - Montana Cancer Consortium Billings, Montana  59101
Meritcare Roger Maris Cancer Center Fargo, North Dakota  58122
Massey Cancer Center Richmond, Virginia  23298-0037
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Holden Comprehensive Cancer Center Iowa City, Iowa  52242-1009
Providence Alaska Medical Center Anchorage, Alaska  99508
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
St. Mary's/Duluth Clinic Cancer Center Duluth, Minnesota  55805-1983
New York Weill Cornell Cancer Center at Cornell University New York, New York  10021
Seattle Cancer Care Alliance Seattle, Washington  98109
Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
Cancer Care of Maine Bangor, Maine  04401
Saint Joseph Mercy Health System Ann Arbor, Michigan  48106
Sioux Valley Clinics - Oncology Sioux Falls, South Dakota  57104