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A Study of Avastin (Bevacizumab) With XELOX or FOLFOX in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI and Avastin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01077739
First received: February 26, 2010
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

This open-label single arm study will evaluate the efficacy and safety of Avastin added to XELOX or FOLFOX in patients with metastatic colorectal cancer and disease progression on 1st line therapy with FOLFIRI plus Avastin. Patients will receive either Avastin (7.5mg/kg iv infusion every 3 weeks) and standard XELOX (Xeloda [capecitabine] plus oxaliplatin) chemotherapy or Avastin (5 mg/kg iv infusion every 2 weeks) and standard FOLFOX (5-FU and leucovorin plus oxaliplatin) chemotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.


Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil (5FU)
Drug: leucovorin
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: A Single-arm Open-label Phase II Study: Treatment Beyond Progression by Adding Bevacizumab to XELOX or FOLFOX Chemotherapy in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line FOLFIRI + Bevacizumab Combination

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) From the Start of Treatment Beyond Progression [ Time Frame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal ] [ Designated as safety issue: No ]
    PFS from the start of treatment beyond progression was defined as the interval between the start of beyond-progression therapy and the date at which disease progression was documented. Progression of disease was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 and abdominal/pelvic computerized tomography (CT) or magnetic resonance imaging (MRI) scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.


Secondary Outcome Measures:
  • PFS From the Start of First-Line Therapy [ Time Frame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal ] [ Designated as safety issue: No ]
    PFS from the start of first-line therapy was defined as the interval between the start of first-line therapy and the date at which second disease progression (after the start of beyond progression therapy) was documented. Progression of disease was evaluated using RECIST version 1.1 and abdominal/pelvic CT or MRI scanning. The same method of assessment and the same technique were to be used to evaluate each lesion throughout the entire study. If more than one method was used, data from the most accurate method according to RECIST were recorded. Median PFS was estimated using the Kaplan-Meier method.

  • Percentage of Participants With an Overall Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline, every 9 weeks until disease progression, at end of treatment or withdrawal ] [ Designated as safety issue: No ]

    Percentage of participants with an overall response of CR or PR according to RECIST criteria.

    CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). 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 nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.


  • Geometric Mean Values of Pro-Angiogenic Cytokine Concentrations at Baseline and Prior to Progression [ Time Frame: Baseline, every 9 weeks until disease progression, at final visit or at withdrawal. ] [ Designated as safety issue: No ]
    Pro-angiogenic cytokine concentrations of placental growth factor (PlGF), basic fibroblast growth factor (bFGF), and hepatocyte growth factor (HGF) in participant sera were measured and reported in units of picograms/milliliter (pg/mL). The geometric mean was calculated as exp10 (mean of log10 transformed concentration) and the standard deviation (SD) is SD of log10 transformed concentration.


Enrollment: 75
Study Start Date: July 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin (bevacizumab) + standard of care Drug: fluorouracil (5FU)
standard FOLFOX regimen
Drug: leucovorin
standard FOLFOX regimen
Drug: bevacizumab [Avastin]
7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks
Drug: capecitabine [Xeloda]
standard XELOX regimen
Drug: oxaliplatin
standard XELOX or FOLFOX regimen

  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
  • metastatic colorectal cancer
  • at least 1 measurable lesion according to RECIST v. 1.1
  • patients with disease progression with prior FOLFIRI + Avastin therapy who are not candidates for primary metastasectomy
  • disease progression </= 8 weeks after last dose of Avastin
  • ECOG </=2
  • No more than 8 weeks between 1st-line treatment with FOLFIRI + Avastin and 2nd-line treatment with XELOX or FOLFOX + Avastin

Exclusion Criteria:

  • disease progression > 8 weeks after last Avastin administration
  • clinically significant cardiovascular disease
  • CNS disease except for treated brain metastasis
  • history of other malignancies within 2 years prior to start of study treatment (with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix)
  • major surgery, open biopsy, or significant traumatic injury within 28 days prior to start of study treatment
  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: NCT01077739

Locations
Belgium
Aalst, Belgium, 9300
Arlon, Belgium, 6700
Assebroek, Belgium, 8310
AYE, Belgium, 6900
Bonheiden, Belgium, 2820
Brasschaat, Belgium, 2930
Brugge, Belgium, 8000
Bruxelles, Belgium, 1200
Bruxelles, Belgium, 1020
Bruxelles, Belgium, 1180
Charleroi, Belgium, 6000
Dendermonde, Belgium, 9200
Edegem, Belgium, 2650
Genk, Belgium, 3600
Gent, Belgium, 9000
Hasselt, Belgium, 3500
Kortrijk, Belgium, 8500
Mechelen, Belgium, 2800
Merksem, Belgium, 2170
Mont-godinne, Belgium, 5530
Montigny-le-Tilleul, Belgium, 6110
Namur, Belgium, 5000
Oostende, Belgium, 8400
Sint-Niklaas, Belgium, 9100
Tournai, Belgium, 7500
Turnhout, Belgium, 2300
Verviers, Belgium, 4800
Wilrijk, Belgium, 2610
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01077739     History of Changes
Obsolete Identifiers: NCT01069679
Other Study ID Numbers: ML22519, 2009-012090-36
Study First Received: February 26, 2010
Results First Received: July 15, 2014
Last Updated: July 15, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Colorectal Neoplasms
Disease Progression
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Disease Attributes
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Pathologic Processes
Rectal Diseases
Bevacizumab
Capecitabine
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014