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

Roche

Status and phase: Completed; Phase 2

Conditions: Liver Cancer

Treatments: Drug: capecitabine [Xeloda]; Drug: bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013830

ML18469

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Avastin + Xeloda

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: capecitabine [Xeloda]