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A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine [Xeloda]
capecitabine [Xeloda]
bevacizumab [Avastin]
oxaliplatin
irinotecan
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients, ≥18 years of age
  • Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
  • ≥1 measurable target lesion
  • Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Exclusion Criteria:

  • Prior systemic therapy for advanced or metastatic disease
  • History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
  • Clinically significant cardiovascular disease
  • Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
  • Chronic daily treatment with >325 mg/day aspirin

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

XELOX + bevacizumab (Q2W)

XELIRI + bevacizumab (Q2W)

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) in U.S. Patients Only
PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.

Secondary Outcome Measures

Full Information

First Posted
March 19, 2008
Last Updated
February 28, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00642603
Brief Title
A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
Official Title
A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XELOX + bevacizumab (Q2W)
Arm Type
Experimental
Arm Title
XELIRI + bevacizumab (Q2W)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
5 mg/kg taken intravenously on Day 1 of each 2 week cycle
Intervention Type
Drug
Intervention Name(s)
oxaliplatin
Intervention Description
85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Intervention Type
Drug
Intervention Name(s)
irinotecan
Intervention Description
135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) in U.S. Patients Only
Description
PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.
Time Frame
From first patient enrolled up to approximately 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, ≥18 years of age Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease ≥1 measurable target lesion Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 Exclusion Criteria: Prior systemic therapy for advanced or metastatic disease History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix Clinically significant cardiovascular disease Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents Chronic daily treatment with >325 mg/day aspirin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
PARK Springs
State/Province
Arizona
ZIP/Postal Code
71913
Country
United States
City
Sedona
State/Province
Arizona
ZIP/Postal Code
86336
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Colton
State/Province
California
ZIP/Postal Code
92324
Country
United States
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
City
Miami Shores
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42002
Country
United States
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-5636
Country
United States
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
City
Huntington Station
State/Province
New York
ZIP/Postal Code
11746
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401-8122
Country
United States
City
Ephrata
State/Province
Pennsylvania
ZIP/Postal Code
17522
Country
United States
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403-5740
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Cookeville
State/Province
Tennessee
ZIP/Postal Code
38501
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76014
Country
United States
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702-1449
Country
United States
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Garland
State/Province
Texas
ZIP/Postal Code
75042
Country
United States
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75067
Country
United States
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
City
Paris
State/Province
Texas
ZIP/Postal Code
75460
Country
United States
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
City
Webster
State/Province
Texas
ZIP/Postal Code
77598-4420
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.roche-trials.com/studyResultGet.action?studyResultNumber=ML21567
Description
Clinical Study Report Synopsis

Learn more about this trial

A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

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