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This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of 2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease progression. Xeloda was administered at a dose of 1000 mg/m^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m^2 intravenously (iv) on day 1 of each cycle, and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab+capecitabine+oxaliplatin | Active Comparator | Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. |
|
| Bevacizumab(B)+capecitabine(C)+oxaliplatin followed by B+C | Experimental | Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab was supplied as a solution in single-use vials. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Baseline to the end of the study (up to 4 years, 2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival was defined as the time from the first administration of study drug to death. | Baseline to the end of the study (up to 4 years, 2 months) |
| Percentage of Participants With a Complete Response or a Partial Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara | 06100 | Turkey (Türkiye) | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab+Capecitabine+Oxaliplatin | Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Capecitabine | Drug | Capecitabine was supplied as film-coated tablets. |
|
|
| Oxaliplatin | Drug | Oxaliplatin was supplied as a lyophilized powder in vials. |
|
|
A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
| Baseline to the end of the study (up to 4 years, 2 months) |
| Time Until a Complete Response or a Partial Response | Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response. | Baseline to Month 13 |
| Duration of Response | Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Baseline to the end of the study (up to 4 years, 2 months) |
| Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery | Baseline to the end of the study (up to 4 years, 2 months) |
| Percentage of Participants With a R0 Resection | An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. | Baseline to the end of the study (up to 4 years, 2 months) |
| Ankara |
| 06500 |
| Turkey (Türkiye) |
| Ankara | 06590 | Turkey (Türkiye) |
| Gaziantep | 27310 | Turkey (Türkiye) |
| Istanbul | 34300 | Turkey (Türkiye) |
| Istanbul | 34390 | Turkey (Türkiye) |
| Istanbul | 34890 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Izmir | 35340 | Turkey (Türkiye) |
| S?hhiye, Ankara | 06100 | Turkey (Türkiye) |
| Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C |
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-treat population: All randomized participants with a least 1 post-randomization efficacy assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab+Capecitabine+Oxaliplatin | Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. |
| BG001 | Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C | Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Progression-free survival was defined as the time from the first administration of study drug to the first documented disease progression or death, whichever occurs first. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. | Posted | Mean | Standard Error | Months | Baseline to the end of the study (up to 4 years, 2 months) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as the time from the first administration of study drug to death. | Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. | Posted | Mean | Standard Error | Months | Baseline to the end of the study (up to 4 years, 2 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Complete Response or a Partial Response | A complete response was defined as the disappearance of all target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. | Posted | Number | Percentage of participants | Baseline to the end of the study (up to 4 years, 2 months) |
| |||||||||||||||||||||||||||||||
| Secondary | Time Until a Complete Response or a Partial Response | Time until a complete response or a partial response was defined as the time from the first administration of study drug until the first complete response or partial response. | Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. Only participants with a complete response or a partial response were included in the analysis. | Posted | Mean | Standard Deviation | Months | Baseline to Month 13 |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was defined as the time from the first complete response or partial response until disease progression or death. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. | Not Posted | Baseline to the end of the study (up to 4 years, 2 months) | |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery | Intent-to-treat population: All randomized participants who had at least 1 post-randomization efficacy assessment. | Posted | Number | Percentage of participants | Baseline to the end of the study (up to 4 years, 2 months) |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a R0 Resection | An R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed. | Not Posted | Baseline to the end of the study (up to 4 years, 2 months) |
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Safety population: All participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab+Capecitabine+Oxaliplatin | Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. | 12 | 62 | 62 | 62 | ||
| EG001 | Bevacizumab(B)+Capecitabine(C)+Oxaliplatin Followed by B+C | Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. | 21 | 61 | 61 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Clinical worsening | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Decreased breath sounds on right lower zone | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Defence, distension and rigidity in abdomen | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Difficulty in breathing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| General situational failure | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Laryngeal edema | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| H1N1 infection (influenza) | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| High level of tiredness | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neutropenic fever | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rapid advanced dyspnea and cyanosis | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rectovaginal fistule | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Severe backache, shivering | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weakness | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hemifacial spasm | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Participants |
|
|
Participants received bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle for 6 cycles followed by bevacizumab 7.5 mg/kg intravenously (IV) on Day 1 of each 3-week cycle + capecitabine 1000 mg/m^2 orally twice a day on Days 1-14 of each 3-week cycle until disease progression. |
|
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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