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Completed

NCT Number: NCT02013830

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Melbourne, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bevacizumab [Avastin]

Drug

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

capecitabine [Xeloda]

Drug

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

Primary outcomes

  1. Percentage of Participants With Objective Response (OR)

    Time frame: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up

    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 outcomes

  1. Percentage of Participants With Disease Control

    Time frame: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up

    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.

  2. Time to Disease Progression - Percentage of Participants With an Event

    Time frame: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up

    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.

  3. Time to Disease Progression

    Time frame: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up

    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.

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

    Time frame: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.

    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.

  5. Overall Survival - Percentage of Participants With an Event

    Time frame: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.

    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.

  6. Overall Survival

    Time frame: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.

    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.

  7. Overall Survival - Percentage of Participants Event Free at 12 Months

    Time frame: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 17, 2013
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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