A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01159171
First received: July 7, 2010
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.


Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ] [ Designated as safety issue: No ]
    Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.

  • Percentage of Participants by Best Overall Response [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ] [ Designated as safety issue: No ]
    Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions.


Secondary Outcome Measures:
  • Duration of Response - Percentage of Participants With an Event by 24 Months [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ] [ Designated as safety issue: No ]
    Duration of overall response (CR or PR) was calculated only for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.

  • Duration of Response [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ] [ Designated as safety issue: No ]
    Duration of overall response (CR or PR) was calculated for participants of the ITT population whose best overall response was CR or PR based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR or PR status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.

  • Duration of Stable Disease - Percentage of Participants With an Event by 24 Months [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ] [ Designated as safety issue: No ]
    Duration of stable response (CR, PR, or stable disease [SD]) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact.

  • Duration of Stable Disease [ Time Frame: Baseline, every 3 months to progression of disease or end of study (up to 24 months) ] [ Designated as safety issue: No ]
    Duration of stable response (CR, PR, or SD) was calculated only for participants of the ITT population whose best overall response was CR, PR, or SD based on RECIST criteria. Duration of overall response was defined as the time from the date of the first assessment of CR, PR, or SD status until the date of progression or death. Data for participants who were alive without any objectively documented disease progression at the end of the study were censored as of the date of last contact. Mean time to event was estimated using the Kaplan-Meier method.

  • Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months [ Time Frame: Baseline, every month to end of treatment (up to 24 months) ] [ Designated as safety issue: No ]
    TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent).

  • Time to Treatment Failure [ Time Frame: Baseline, monthly to end of study (up to 24 months) ] [ Designated as safety issue: No ]
    TTF was defined as the time in months from Day 1 until discontinuation of treatment for any reasons. These reasons included: death due to any cause, treatment toxicity (adverse event), insufficient therapeutic response (progression of disease), failure to return (lost to follow-up), refusing treatment (participant non-compliance), being unwilling to cooperate and withdrawing consent (participant withdrew consent). Mean TTF was estimated using the Kaplan-Meier method.

  • Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months [ Time Frame: Baseline, monthly to end of study (up to 24 months) ] [ Designated as safety issue: No ]
    TTP was defined as the time time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1.

  • Time to Progression [ Time Frame: Baseline, monthly to end of study (up to 24 months) ] [ Designated as safety issue: No ]
    TTP was defined as the time in months from Day 1 until the date of first documented progressive disease, or death due to any cause. Data for participants who were alive without disease progression at the end of study, or who were non-responder participants (without tumor assessment after baseline) were censored at Day 1. Mean TTP was estimated using the Kaplan-Meier method.

  • Overall Survival (OS) - Percentage of Participants With an Event by 24 Months [ Time Frame: Baseline, monthly to end of study (up to 24 months) ] [ Designated as safety issue: No ]
    OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit.

  • Overall Survival [ Time Frame: Baseline, monthly to end of study (up to 24 months) ] [ Designated as safety issue: No ]
    OS was defined as the time in months from Day 1 until the date of death due to any cause. Data for participants who were alive at the end of the study were censored at the date of the last available follow-up visit. Mean OS was estimated using the Kaplan-Meier method.


Enrollment: 50
Study Start Date: January 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
5 mg/kg intravenously every 14 days
Drug: capecitabine [Xeloda]
1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle
Drug: oxaliplatin
40 mg/m2 iv weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients >=18 years of age
  • Locally advanced or metastatic colorectal cancer
  • No previous treatment with chemotherapy for metastatic disease
  • Measurable and/or evaluable lesions

Exclusion Criteria:

  • Radiotherapy within 4 weeks before study
  • Untreated brain metastases or primary brain tumors
  • Chronic, daily treatment with high-dose aspirin (>325mg/day)
  • Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159171

Locations
Italy
Aviano, Italy, 33081
Fano, Italy, 61032
Palermo, Italy, 90146
Rimini, Italy, 47900
Roma, Italy, 00135
Torino, Italy, 10126
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01159171     History of Changes
Other Study ID Numbers: ML18523
Study First Received: July 7, 2010
Results First Received: May 20, 2014
Last Updated: July 24, 2014
Health Authority: Italy: Italian Medicines Agency (AIFA)

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Capecitabine
Oxaliplatin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014