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

Primary Purpose

Colorectal Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bevacizumab

Floxuridine

Irinotecan

Leucovorin

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination Chemotherapy and Bevacizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Survival up to 2 Years

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

Secondary Outcome Measures

Response Rate (Complete Response and Partial Response)

Percentage of patients achieving complete response or partial response per RECIST criteria ver 1.0

Median Progression-free Survival in Months

Median number of months subjects achieved progression-free survival

Rate of Toxicity in Study Participants

Evaluation the safety and toxicities of protocol regimen as evidenced by the rate of serious adverse events in study participants.

Full Information

NCT ID

NCT00449163

First Posted

March 15, 2007

Last Updated

April 5, 2017

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT00449163

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

Study terminated by University of Miami Institutional Review Board

Study Start Date

March 1, 2006 (Actual)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Miami

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

For the purpose of this study treatment cycle consist of six 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 according to the schedule. There will be no treatment delivered on weeks 3 & 6 (Days 15 and 36). Disease will be evaluated by CT scan at the completion of every two cycles. Patients with complete response (CR), or partial response (PR), will be evaluated for possible surgical resection. Patients who become operable will continue to be evaluated for survival and disease relapse. Patients with stable disease (SD), and those with less than pCR after surgery should continue chemotherapy until radiographic evidence of tumor progression is identified or unacceptable side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combination Chemotherapy and Bevacizumab

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Type

Drug

Intervention Name(s)

Floxuridine

Other Intervention Name(s)

5-fluorodeoxyuridine

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Other Intervention Name(s)

Irinotecan Hydrochloride, Camptosar

Intervention Type

Drug

Intervention Name(s)

Leucovorin

Other Intervention Name(s)

Leucovorin calcium

Primary Outcome Measure Information:

Title

Overall Survival up to 2 Years

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Response Rate (Complete Response and Partial Response)

Description

Percentage of patients achieving complete response or partial response per RECIST criteria ver 1.0

Time Frame

2 years

Title

Median Progression-free Survival in Months

Description

Median number of months subjects achieved progression-free survival

Time Frame

2 years

Title

Rate of Toxicity in Study Participants

Description

Evaluation the safety and toxicities of protocol regimen as evidenced by the rate of serious adverse events in study participants.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bach Ardalan, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

result

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

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