Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 88 of 441 for:    colon cancer AND Capecitabine AND colon cancer

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01159171
Recruitment Status : Completed
First Posted : July 9, 2010
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Interventions Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Drug: oxaliplatin
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description Participants received bevacizumab 5 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1 and 15; oxaliplatin 40 mg per square meter (mg/m^2) IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Period Title: Overall Study
Started 50
Completed 0
Not Completed 50
Reason Not Completed
Adverse Event             11
Progression of Disease             28
Protocol Violation             1
Need for Surgery             5
Medical Decision             4
Death             1
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
Safety population: all participants who received at least one dose of one study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
59.08  (9.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
25
  51.0%
Male
24
  49.0%
1.Primary Outcome
Title Percentage of Participants With Objective Response (OR)
Hide Description 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.
Time Frame Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) Population: all participants who signed the informed consent, were assigned a study patient number, and who were administered at least 1 dose of 1 study medication.
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
42.86
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab + Oxaliplatin + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0047
Comments One-sided p-value
Method One sample exact binomial test
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants by Best Overall Response
Hide Description 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.
Time Frame Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. 5 participants were not assessed as they did not reach the 3 month time-point.
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Cycle 1 (28-Day Cycle) Participants received 5 milligrams/kilograms (mg/kg) bevacizumab intravenously (IV) on Days 1 and 15; 40 mg/meter^2 (mg/m^2) oxaliplatin IV on Days 1, 8, 15, and 22; and 2000 mg/m^2 capecitabine orally (PO) in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14 followed by a rest period on Days 15 through 28. Cycle 1 was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
CR 4.08
PR 38.78
SD 38.78
PD 8.16
3.Secondary Outcome
Title Duration of Response - Percentage of Participants With an Event by 24 Months
Hide Description 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.
Time Frame Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with a best overall response of CR or PR were included in the analysis.
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: percentage of participants
57.14
4.Secondary Outcome
Title Duration of Response
Hide Description 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.
Time Frame Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; only participants with a best overall response of CR or PR were included in the analysis.
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: months
8.31  (1.97)
5.Secondary Outcome
Title Duration of Stable Disease - Percentage of Participants With an Event by 24 Months
Hide Description 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.
Time Frame Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; only participants with a best overall response of CR, PR, or SD were included in the analysis.
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of participants
52.50
6.Secondary Outcome
Title Duration of Stable Disease
Hide Description 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 Frame Baseline, every 3 months to progression of disease or end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population: only participants with a best overall response of CR, PR, or SD were included in the analysis.
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: months
10.09  (1.30)
7.Secondary Outcome
Title Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months
Hide Description 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 Frame Baseline, every month to end of treatment (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
81.63
8.Secondary Outcome
Title Time to Treatment Failure
Hide Description 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 Frame Baseline, monthly to end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 49
Mean (Standard Deviation)
Unit of Measure: months
7.44  (0.84)
9.Secondary Outcome
Title Time to Progression (TTP) - Percentage of Participants With an Event by 24 Months
Hide Description 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 Frame Baseline, monthly to end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
91.84
10.Secondary Outcome
Title Time to Progression
Hide Description 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.
Time Frame Baseline, monthly to end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 49
Mean (Standard Deviation)
Unit of Measure: months
9.61  (0.90)
11.Secondary Outcome
Title Overall Survival (OS) - Percentage of Participants With an Event by 24 Months
Hide Description 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.
Time Frame Baseline, monthly to end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
89.90
12.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame Baseline, monthly to end of study (up to 24 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 49
Mean (Standard Deviation)
Unit of Measure: months
20.23  (1.68)
Time Frame Adverse events (AEs) were collected form the date of first study-drug intake until 28 days after the date of last study-drug intake.
Adverse Event Reporting Description All participants who received at least 1 dose of study treatment were included in the safety population. Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
 
Arm/Group Title Bevacizumab + Oxaliplatin + Capecitabine
Hide Arm/Group Description Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
All-Cause Mortality
Bevacizumab + Oxaliplatin + Capecitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab + Oxaliplatin + Capecitabine
Affected / at Risk (%)
Total   18/49 (36.73%) 
Cardiac disorders   
Angina pectoris * 1  1/49 (2.04%) 
Gastrointestinal disorders   
Diarrhea * 1  2/49 (4.08%) 
Gastrointestinal obstruction * 1  1/49 (2.04%) 
Intestinal obstruction * 1  1/49 (2.04%) 
Subileus * 1  3/49 (6.12%) 
General disorders   
Pain * 1  1/49 (2.04%) 
Injury, poisoning and procedural complications   
Femur fracture * 1  1/49 (2.04%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/49 (2.04%) 
Nervous system disorders   
Syncope * 1  1/49 (2.04%) 
Transient ischaemic attack * 1  1/49 (2.04%) 
Renal and urinary disorders   
Hematuria * 1  1/49 (2.04%) 
Reproductive system and breast disorders   
Pelvic pain * 1  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/49 (2.04%) 
Vascular disorders   
Deep vein thrombosis * 1  1/49 (2.04%) 
Hypertensive crisis * 1  1/49 (2.04%) 
Vena cava thrombosis * 1  2/49 (4.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab + Oxaliplatin + Capecitabine
Affected / at Risk (%)
Total   48/49 (97.96%) 
Blood and lymphatic system disorders   
Anaemia * 1  3/49 (6.12%) 
Neutropenia * 1  7/49 (14.29%) 
Thrombocytopenia * 1  11/49 (22.45%) 
Gastrointestinal disorders   
Abdominal pain * 1  14/49 (28.57%) 
Abdominal pain upper * 1  7/49 (14.29%) 
Constipation * 1  10/49 (20.41%) 
Diarrhea * 1  22/49 (44.90%) 
Gingival bleeding * 1  3/49 (6.12%) 
Nausea * 1  19/49 (38.78%) 
Stomatitis * 1  5/49 (10.20%) 
Subileus * 1  3/49 (6.12%) 
Vomiting * 1  15/49 (30.61%) 
General disorders   
Asthenia * 1  11/49 (22.45%) 
Fatigue * 1  9/49 (18.37%) 
Mucosal inflammation * 1  9/49 (18.37%) 
Pyrexia * 1  12/49 (24.49%) 
Infections and infestations   
Influenza * 1  4/49 (8.16%) 
Investigations   
Blood alkaline phosphatase increased * 1  4/49 (8.16%) 
Blood lactate dehydrogenase increased * 1  4/49 (8.16%) 
Neutrophil count * 1  3/49 (6.12%) 
Metabolism and nutrition disorders   
Anorexia * 1  3/49 (6.12%) 
Hypokalaemia * 1  5/49 (10.20%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  4/49 (8.16%) 
Back pain * 1  3/49 (6.12%) 
Nervous system disorders   
Headache * 1  4/49 (8.16%) 
Neuropathy peripheral * 1  13/49 (26.53%) 
Paraesthesia * 1  22/49 (44.90%) 
Sciatica * 1  3/49 (6.12%) 
Syncope * 1  3/49 (6.12%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/49 (6.12%) 
Epistaxis * 1  6/49 (12.24%) 
Skin and subcutaneous tissue disorders   
Palmar-plantar erythrodysaesthesia syndrome * 1  9/49 (18.37%) 
Rash * 1  4/49 (8.16%) 
Vascular disorders   
Hypertension * 1  12/49 (24.49%) 
Phlebitis * 1  4/49 (8.16%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01159171     History of Changes
Other Study ID Numbers: ML18523
First Submitted: July 7, 2010
First Posted: July 9, 2010
Results First Submitted: May 20, 2014
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014