Neoplasms

Digestive System Diseases

All Conditions

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Capecitabine

Bevacizumab

Liver Extracts

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

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

bevacizumab [Avastin]

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

capecitabine [Xeloda]

Clinical Trials

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.

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

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

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.

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 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 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.

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 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.

Hoffmann-La Roche

Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m\^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.

Bevacizumab/Capecitabine

Age, Continuous

Sex: Female, Male

All enrolled participants who received at least 1 dose of study drug.

Medical Communications

Per Protocol (PP) Population included participants who: received greater than or equal to (≥) 1 dose of study medication, ≥6 weeks of treatment (unless excluded for allowed reasons), did not severely violate inclusion/exclusion criteria, had tumor assessment, greater than (\>) 50% of first 6 weeks of treatment, and were not replaced.

Percentage of Participants With Objective Response (OR)

Percentage of Participants With Disease Control

Time to Disease Progression - Percentage of Participants With an Event

Intent-To-Treat (ITT) Population included all enrolled participants who received at least one dose of study medication.

Time to Disease Progression

Time to Disease Progression - Percentage of Participants Progression-free at 12 Months

Overall Survival - Percentage of Participants With an Event

Overall Survival

Overall Survival - Percentage of Participants Event Free at 12 Months

A cycle was defined as the following: Participants received 7.5 milligrams per kilogram (mg/kg) bevacizumab intravenously (IV) on Day 1; and 1600 mg per square meter per day (mg/m\^2/day) capecitabine tablets, orally (PO), in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.

Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial