A Study of Tarceva (Erlotinib) and Avastin (Bevacizumab) in Patients With Advanced or Metastatic Liver Cancer.

NCT ID: NCT00605722

Last Updated: 2014-07-14

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-09-30

Brief Summary

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This single arm study evaluated the efficacy and safety of a combination of Tarceva and Avastin in patients with advanced or metastatic liver cancer. Patients were treated with Tarceva 150 mg po daily plus Avastin 5 mg/kg intravenous (iv) every 2 weeks. The anticipated time on study treatment was until disease progression, and the target sample size was \<100 individuals.

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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bevacizumab + erlotinib

Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.

Group Type EXPERIMENTAL

bevacizumab (Avastin)

Intervention Type DRUG

5 mg/kg iv on day 1 of each 2 week cycle.

erlotinib (Tarceva)

Intervention Type DRUG

150 mg orally (po) daily.

Interventions

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bevacizumab (Avastin)

5 mg/kg iv on day 1 of each 2 week cycle.

Intervention Type DRUG

erlotinib (Tarceva)

150 mg orally (po) daily.

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, not previously treated with local therapy within 4 weeks of enrollment.

Exclusion Criteria

* prior or concomitant systemic anti-cancer treatment for advanced disease;
* patients at high risk of variceal bleeding;
* clinically significant cardiovascular disease;
* major surgery, open biopsy, or significant traumatic injury within 4 weeks of study start.
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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Manila, , Philippines

Site Status

Seoul, , South Korea

Site Status

Kueishan, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Countries

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Philippines South Korea Taiwan

Other Identifiers

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ML21213

Identifier Type: -

Identifier Source: org_study_id

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