Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01135498
First received: June 1, 2010
Last updated: January 22, 2015
Last verified: January 2015

June 1, 2010
January 22, 2015
November 2006
April 2010   (final data collection date for primary outcome measure)
  • Percentage of Participants With Disease Progression or Death [ Time Frame: Start of study to approximately 4 years ] [ Designated as safety issue: No ]
    Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
  • Progression-Free Survival [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
    Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery).
Progression-free survival (PFS) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01135498 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
    Percentage of participants with objective response based assessment of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST). 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]) and 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.
  • Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC]) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
    Percent of participants with confirmed CR, PR, or NC. Per RECIST version (v)1.0: CR was defined as disappearance of all target and non-target lesions. PR was defined as ≥30% decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non-target lesions. NC was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions.
  • Percentage of Participants Who Died [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
    Overall survival was defined as the time from the date of informed consent to the date of death (regardless of the cause of death). There was no restriction; survival was calculated until the date of death, even if another line of treatment was received, or until the date censored (last contact with the participant even if drugs different from the study treatment schedule were received). For all participants, survival information was collected until the date of death, the last contact, or the last follow-up.
  • Overall response rate (ORR) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
  • Abnormal laboratory values [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.
An Open-label Study of the Effect of First-line Treatment With Avastin+Xelox, Followed by Avastin+Tarceva, on Progression-free Survival in Patients With Metastatic Colorectal Cancer

This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: bevacizumab [Avastin]
    Intravenous repeating dose
  • Drug: eloxatin
    Intravenous repeating dose
  • Drug: capecitabine [Xeloda]
    Oral repeating dose
  • Drug: erlotinib [Tarceva]
    Oral repeating dose
Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: eloxatin
  • Drug: capecitabine [Xeloda]
  • Drug: erlotinib [Tarceva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • adenocarcinoma of colon or rectum, with metastatic disease;
  • >=1 measurable lesion.

Exclusion Criteria:

  • previous treatment with Avastin or Tarceva;
  • previous systemic treatment for advanced or metastatic disease;
  • adjuvant treatment for non-metastatic disease in past 6 months.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01135498
ML19875
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP