Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer

NCT00449163 | Terminated Phase 2 Results DMC

• 3 other identifiers: 20060042SCCC-2005145WIRB-20060252
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, 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 colorectal 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 colorectal cancer.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival up to 2 Years

  Percentage of patients with overall survival times of up to 2 years

  2 years

Secondary Outcomes (3)

• Response Rate (Complete Response and Partial Response)

  2 years

• Median Progression-free Survival in Months

  2 years

• Rate of Toxicity in Study Participants

  2 years

Study Arms (1)

Combination Chemotherapy and Bevacizumab

EXPERIMENTAL

Treatment cycle is 6 weeks, 2 weeks of consecutive treatment followed by 1 week of rest and 2 weeks of treatment followed by one week of rest. Treatment will be administered weekly, 4 out 6 weeks, on days 1, 8, 22 and 29: * Bevacizumab: 7.5mg/kg via intravenous (IV) infusion on Days 1 and 22; * Irinotecan: 110 mg/m\^2 via IV infusion on Days 1, 8, 22, 29; * Leucovorin: 500 mg/m\^2 via IV infusion on Days 1, 8, 22 and 29; * Floxuridine: 120 mg/kg over continuous infusion on Days 1, 8, 22 and 29.

Biological: Bevacizumab; Drug: Floxuridine; Drug: Irinotecan; Drug: Leucovorin

Interventions

Bevacizumab BIOLOGICAL

Also known as: Avastin

Combination Chemotherapy and Bevacizumab

Floxuridine DRUG

Also known as: 5-fluorodeoxyuridine

Combination Chemotherapy and Bevacizumab

Irinotecan DRUG

Also known as: Irinotecan Hydrochloride, Camptosar

Combination Chemotherapy and Bevacizumab

Leucovorin DRUG

Also known as: Leucovorin calcium

Combination Chemotherapy and Bevacizumab

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have stage IV, histologically confirmed diagnosis of Adenocarcinoma of the colon.
• Patients must have bi-dimensionally measurable disease since the purpose of this study is to determine efficacy of treatment.
• Patients must be previously untreated.
• Patients must be over the age of 18 years.
• Patients may not be pregnant. Patients of childbearing years must be using contraception.
• Patients must have ECOG performance status of 0-1 or KPS of at least 70.
• Patients must have life expectancy of ≥ two months.
• Patients must have a white blood cell count of ≥1000/mm³ ANC \> 1.0, platelets \> 100,000/mm³.
• Patients must have adequate renal function as documented by a serum creatinine of ≤ 1.5 mg/dl.
• Patients must have a bilirubin of ≤ 1.5 mg/dl and an SGOT of ≤ three times normal for patients with no liver disease, and ≤ five times normal for those with liver metastases.
• Patients must be informed of the investigational nature of the study and give written informed consent.
• Patients must have indwelling central venous catheter or good peripheral intravenous catheter, preferably a port-a-cath.
• Patients may have had prior surgery for their colorectal cancer. Patients must be at least 8 weeks beyond surgery and recovered from all effects of surgery.
• Patients enrolled in this study may have a history of prior malignancy (5 years ago) provided that the patient is currently disease-free.

You may not qualify if:

• Patients who have had prior chemotherapy or radiation therapy for their colorectal cancer, with exception of adjuvant chemo/radiation therapy.
• Patients receiving concomitant radiation, hormonal therapy, chemotherapy, or immunotherapy.
• Patients receiving any investigational drug within 30 days prior to start of this study.
• Patients with serious underlying medical illnesses (including Congestive Heart Failure New York Heart Association Functional Classification 2-4) or active infection.
• Patients with central nervous system metastasis must have completed radiation prior to entry into this protocol.
• Patients with psychiatric conditions or associated conditions which would make participating in this study dangerous to their health.
• Patients with uncontrolled hypertension.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Phase II study of bevacizumab (B), camptosar (I), high-dose 24-hour continuous intravenous infusion of floxuridine (F) and leucovorin (L) in patients with previously untreated metastatic colon cancer. (B-IFL) B. Ardalan, M. Feagans, D. Mezentsev, C. Jones, P. R. Subbarayan, G. Walker, M. Sapp, K. Stephenson, J. Ness, D. Franceschi, and A. Livingstone Journal of Clinical Oncology 2009 27:15S, e15114-e15114

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab; Floxuridine; Irinotecan; 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; Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Limitations and Caveats

A total of 25 subjects were enrolled however; data were analyzed for 22 subjects only. Study was terminated early by the University of Miami Institutional Review Board.

Results Point of Contact

• Title: Bach Ardalan MD
• Organization: UM/Sylvester Comprehensive Cancer Center

bardalan@med.miami.edu

305-243-4909

Study Officials

• Bach Ardalan, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: March 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 11, 2017
• Results First Posted: February 28, 2013

Record last verified: 2017-04

Locations

US (1)