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

NCT ID: NCT02013830

Last Updated: 2014-06-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Avastin + Xeloda

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

7.5mg/kg iv on day 1 of each 3 week cycle.

capecitabine [Xeloda]

Intervention Type DRUG

1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.

Interventions

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bevacizumab [Avastin]

7.5mg/kg iv on day 1 of each 3 week cycle.

Intervention Type DRUG

capecitabine [Xeloda]

1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Melbourne, , Australia

Site Status

Hong Kong, , Hong Kong

Site Status

Singapore, , Singapore

Site Status

Kueishan, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Countries

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Australia Hong Kong Singapore Taiwan

Other Identifiers

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ML18469

Identifier Type: -

Identifier Source: org_study_id

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