A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.
|ClinicalTrials.gov Identifier: NCT01135498|
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : February 6, 2015
Last Update Posted : February 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: bevacizumab [Avastin] Drug: eloxatin Drug: capecitabine [Xeloda] Drug: erlotinib [Tarceva]||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Drug: bevacizumab [Avastin]
Intravenous repeating dose
Intravenous repeating dose
Drug: capecitabine [Xeloda]
Oral repeating dose
Drug: erlotinib [Tarceva]
Oral repeating dose
- Percentage of Participants With Disease Progression or Death [ Time Frame: Start of study to approximately 4 years ]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 ]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).
- Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) [ Time Frame: From study start up to approximately 4 years ]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 ]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 ]
- Overall Survival (OS) [ Time Frame: From study start up to approximately 4 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135498
|Sabadell, Barcelona, Barcelona, Spain, 08208|
|Terrassa, Barcelona, Spain, 08221|
|Santander, Cantabria, Spain, 39008|
|Palma de Mallorca, Islas Baleares, Spain, 07198|
|Logroño, La Rioja, Spain, 26006|
|Barakaldo, Vizcaya, Spain, 48903|
|Burgos, Spain, 09006|
|Huesca, Spain, 22004|
|Jaen, Spain, 23007|
|Lerida, Spain, 25198|
|Teruel, Spain, 44002|
|Zaragoza, Spain, 50009|
|Study Chair:||Clinical Trials||Hoffmann-La Roche|