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

Colorectal Cancer Clinical Trial

Official title:

Phase II Study of Avastin, Irinotecan, High Dose 24 Hour Continuous Intravenous Infusion of Floxuridine and Leucovorin in Patients With Previously Untreated Metastatic Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00449163
• Other study ID #: UMIAMI-20060042
• Secondary ID: SCCC-2005145WIRB
• Status: Terminated
• Phase: Phase 2
• First received: March 15, 2007
• Last updated: July 25, 2014
• Start date: March 2006
• Est. completion date: March 2010

Study information

• Verified date: August 2013
• Source: University of Miami Sylvester Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

Primary

• Determine whether irinotecan hydrochloride, floxuridine, leucovorin calcium, and bevacizumab improves overall survival of patients with stage IV colorectal cancer.

Secondary

• Estimate response rate (complete response and partial response), time to response, and progression-free survival of patients treated with this regimen.

• Estimate the resectability rate in patients treated with this regimen.

• Evaluate the safety and toxicity of this regimen.

• Assess the quality of life of patients treated with this regimen.

OUTLINE: Patients receive bevacizumab IV over 90 minutes on days 1 and 22 and irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 24 hours, and high-dose floxuridine IV over 24 hours on days 1, 8, 22, and 29. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are evaluated after completion of every 2 courses of therapy. Patients whose disease is deemed operable at evaluation are referred to surgery.

Patients complete a quality of life assessment at baseline, every 6 weeks during study treatment, and periodically at follow-up.

After completion of study treatment, patients are followed every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon and/or rectum

• Stage IV disease

• Bidimensionally measurable disease

• CNS metastasis allowed provided radiotherapy has been completed

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%

• Life expectancy = 2 months

• Absolute neutrophil count > 1,000/mm³

• Platelet count = 100,000/mm³

• Creatinine = 1.5 mg/dL

• Bilirubin = 1.5 mg/dL

• AST = 3 times upper limit of normal (5 times ULN if liver metastases are present)

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years

• No active infection

• No New York Heart Association class II-IV congestive heart failure

• No serious underlying medical illness

• No psychiatric condition or associated condition that would preclude study participation

• No uncontrolled hypertension

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy or radiotherapy for colorectal cancer, except for adjuvant chemotherapy or radiotherapy

• At least 8 weeks since prior surgery for colorectal cancer and recovered

• At least 30 days since prior investigational drugs

• No concurrent radiotherapy, hormonal therapy, or other chemotherapy or immunotherapy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Biological:
• bevacizumab

Drug:
• floxuridine

• irinotecan hydrochloride

• leucovorin calcium

Procedure:
• adjuvant therapy

• neoadjuvant therapy

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami Sylvester Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

B. Ardalan, M. Feagans, D. Mezentsev, C. Jones, P. R. Subbarayan, G. Walker, M. Sapp, K. Stephenson, J. Ness, D. Franceschi and A. Livingstone. Phase II study of bevacizumab (B), camptosar (I), high-dose 24-hour continuous intravenous infusion of floxurid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival up to 2 Years	Percentage of patients with overall survival times of up to 2 years	2 years	No
Secondary	Response Rate (Complete Response and Partial Response)	Percentage of patients achieving complete response or partial response per RECIST criteria ver 1.0	2 years	No
Secondary	Median Progression-free Survival in Months	Median number of months subjects achieved progression-free survival	2 years	No
Secondary	Toxicity		2 years	Yes