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

• ClinicalTrials.gov Identifier: NCT02013830
• Recruitment Status: Completed
• First Posted: December 17, 2013
• Results First Posted: June 6, 2014
• Last Update Posted: June 6, 2014
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Liver Cancer	Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: May 2005
• Actual Primary Completion Date: March 2008
• Actual Study Completion Date: March 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Avastin + Xeloda	Drug: bevacizumab [Avastin]; 7.5mg/kg iv on day 1 of each 3 week cycle.; Drug: capecitabine [Xeloda]; 1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Australia

Melbourne, Australia, 3181

Hong Kong

Hong Kong, Hong Kong

Singapore

Singapore, Singapore, 169610

Taiwan

Kueishan, Taiwan, 333

Taipei, Taiwan, 00112

Taipei, Taiwan, 106

Taipei, Taiwan, 114

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

More Information

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02013830
• Other Study ID Numbers: ML18469
• First Posted: December 17, 2013
• Results First Posted: June 6, 2014
• Last Update Posted: June 6, 2014
• Last Verified: May 2014

Additional relevant MeSH terms:

Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Bevacizumab; Capecitabine; Antineoplastic Agents, Immunological; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action