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A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bevacizumab [Avastin]
capecitabine [Xeloda]
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • adult patients >=18 years of age;
  • advanced or metastatic liver cancer;
  • >=1 measurable lesion.

Exclusion Criteria:

  • current radiotherapy, chemotherapy, or other experimental therapies;
  • prior cytotoxic chemotherapy;
  • major surgery, open biopsy, or traumatic injury within 28 days of study entry;
  • history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Avastin + Xeloda

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.

Secondary Outcome Measures

Percentage of Participants With Disease Control
The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease.
Time to Disease Progression - Percentage of Participants With an Event
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
Time to Disease Progression
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.
Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
Overall Survival - Percentage of Participants With an Event
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
Overall Survival
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method.
Overall Survival - Percentage of Participants Event Free at 12 Months
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.

Full Information

First Posted
December 3, 2013
Last Updated
May 7, 2014
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02013830
Brief Title
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer
Official Title
A Single-arm, Open-label Study of Avastin Plus Xeloda on Objective Treatment Response in Patients With Advanced or Metastatic Liver Cancer Who Have Had no Previous Cytotoxic Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Avastin + Xeloda
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
7.5mg/kg iv on day 1 of each 3 week cycle.
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.
Primary Outcome Measure Information:
Title
Percentage of Participants With Objective Response (OR)
Description
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.
Time Frame
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Secondary Outcome Measure Information:
Title
Percentage of Participants With Disease Control
Description
The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease.
Time Frame
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Title
Time to Disease Progression - Percentage of Participants With an Event
Description
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
Time Frame
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Title
Time to Disease Progression
Description
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.
Time Frame
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Title
Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
Description
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
Time Frame
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Title
Overall Survival - Percentage of Participants With an Event
Description
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
Time Frame
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Title
Overall Survival
Description
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method.
Time Frame
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Title
Overall Survival - Percentage of Participants Event Free at 12 Months
Description
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
Time Frame
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.

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; advanced or metastatic liver cancer; >=1 measurable lesion. Exclusion Criteria: current radiotherapy, chemotherapy, or other experimental therapies; prior cytotoxic chemotherapy; major surgery, open biopsy, or traumatic injury within 28 days of study entry; history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.
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
Melbourne
ZIP/Postal Code
3181
Country
Australia
City
Hong Kong
Country
Hong Kong
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
City
Kueishan
ZIP/Postal Code
333
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
City
Taipei
ZIP/Postal Code
114
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer

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