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ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
5-Fluorouracil, leucovorin, oxaliplatin, avastin
Sponsored by
Southwestern Regional Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Advanced, metastatic, colorectal, cancer, Avastin

Eligibility Criteria

18 Years - 86 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological proof of adenocarcinoma in primary colon or rectum tumor.
  • Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease.
  • Ages 18 to 86 years.
  • Presence of at least one bi-dimensionally measurable disease with at least one diameter > or = 2 cm.
  • WHO/ECOG performance status < 3 (0, 1, or 2)
  • Prior treatment with oxaliplatin, 5-FU, or leucovorin permitted.
  • Signed informed consent

Exclusion Criteria:

  • Peripheral sensory neuropathy > or = grade 3.
  • Serum bilirubin (total) > 3 X ULN.
  • Symptomatic or uncontrolled brain metastasis.
  • Metastases limited to bone, pleural effusion, or ascites.
  • Uncontrolled overt cardiac disease.
  • Uncontrolled hypercalcemia.
  • Uncontrolled infections.
  • Uncontrolled hypertension (>180/110)
  • History of GI perforation.
  • History of arterial thromboembolic events.
  • History of congestive heart failure.
  • Patients taking warfarin (Coumadin).
  • Patients who are pregnant.

Sites / Locations

  • Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.

Outcomes

Primary Outcome Measures

The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2006
Last Updated
October 31, 2007
Sponsor
Southwestern Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00385021
Brief Title
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
Official Title
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Terminated
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Southwestern Regional Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine efficacy in the delivery of chronomodulated chemotherapy.
Detailed Description
The purpose of this study is to determine if treatment with 5-Fluorouracil, leucovorin, oxaliplatin, and Avastin will cause colorectal tumor cells to shrink or disappear. The study will also determine the safety of these drugs when given together and the quality of life of the patients who are enrolled in the study. It is thought that these drugs will be better tolerated if they are chronomodulated, i.e., if they are given at certain times of day rather than as a continuous infusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Advanced, metastatic, colorectal, cancer, Avastin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil, leucovorin, oxaliplatin, avastin
Primary Outcome Measure Information:
Title
The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological proof of adenocarcinoma in primary colon or rectum tumor. Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease. Ages 18 to 86 years. Presence of at least one bi-dimensionally measurable disease with at least one diameter > or = 2 cm. WHO/ECOG performance status < 3 (0, 1, or 2) Prior treatment with oxaliplatin, 5-FU, or leucovorin permitted. Signed informed consent Exclusion Criteria: Peripheral sensory neuropathy > or = grade 3. Serum bilirubin (total) > 3 X ULN. Symptomatic or uncontrolled brain metastasis. Metastases limited to bone, pleural effusion, or ascites. Uncontrolled overt cardiac disease. Uncontrolled hypercalcemia. Uncontrolled infections. Uncontrolled hypertension (>180/110) History of GI perforation. History of arterial thromboembolic events. History of congestive heart failure. Patients taking warfarin (Coumadin). Patients who are pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra Ketterl, MD
Organizational Affiliation
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

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