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

NCT02013830 | Completed Phase 2 Results

• 1 other identifier: ML18469
• Study Type: interventional
• Target: 45
• Locations: 4 countries
• Sites: 7

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response (OR)

  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.

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

Secondary Outcomes (7)

• Percentage of Participants With Disease Control

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

• Time to Disease Progression - Percentage of Participants With an Event

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

• Time to Disease Progression

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

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

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

• Overall Survival - Percentage of Participants With an Event

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

Study Arms (1)

Avastin + Xeloda

EXPERIMENTAL

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

Interventions

bevacizumab [Avastin] DRUG

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

Avastin + Xeloda

capecitabine [Xeloda] DRUG

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

Avastin + Xeloda

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients \>=18 years of age;
• advanced or metastatic liver cancer;
• \>=1 measurable lesion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Unknown Facility

Melbourne, 3181, Australia

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Singapore, 169610, Singapore

Location

Unknown Facility

Kueishan, 333, Taiwan

Location

Unknown Facility

Taipei, 00112, Taiwan

Location

Unknown Facility

Taipei, 106, Taiwan

Location

Unknown Facility

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Bevacizumab; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 17, 2013
• Study Start: May 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 6, 2014
• Results First Posted: June 6, 2014

Record last verified: 2014-05

Locations

HK (1); SG (1); AU (1); TW (4)