Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab [Avastin] | Drug | 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Overall Disease Control (ODC) | ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR 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) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met. | Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Best Overall Response of CR or PR | Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers | 49933 | France | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab + Chemotherapy | Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) |
| Progression-Free Survival (PFS) - Percentage of Participants With an Event | PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) |
| PFS - Time to Event | PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method. | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) |
| Duration of Response | Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method. | Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up) |
| Duration of Overall Disease Control | ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method. | Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up) |
| Overall Survival (OS) - Percentage of Participants With an Event | Overall survival was defined as the time from start of study treatment to death from any cause. | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) |
| OS - Time to Event | OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method. | Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up) |
| Besançon |
| 25030 |
| France |
| Boulogne-Billancourt | 92104 | France |
| Colmar | 68024 | France |
| Dijon | 21079 | France |
| La Roche-sur-Yon | 85925 | France |
| Marseille | 13005 | France |
| Montpellier | 34298 | France |
| Neuilly-sur-Seine | 92200 | France |
| Nice | 06189 | France |
| Paris | 75679 | France |
| Pierre-Bénite | 69310 | France |
| Reims | 51092 | France |
| Saint-Cloud | 92210 | France |
| Saint-Herblain | 44805 | France |
| Toulouse | 31052 | France |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population: included participants who received at least 1 dose of treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab + Chemotherapy | Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant. |
| 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 | Percentage of Participants Achieving Overall Disease Control (ODC) | ODC was defined as the percentage of participants with measurable disease at baseline who on assessment achieved complete response (CR), partial response (PR), or stable disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR 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) of all target lesions. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since start of treatment. CR and PR were confirmed no less than 4 weeks after the criteria for response were met. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up) |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a Best Overall Response of CR or PR | Percentage of participants achieving CR or PR as defined by RECIST criteria. CR defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as ≥30% decrease under baseline of the sum of the LD of all target lesions. CR and PR were confirmed no less than 4 weeks after the criteria for response were met. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) - Percentage of Participants With an Event | PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. | ITT | Posted | Number | percentage of participants | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) |
|
| |||||||||||||||||||||||||||
| Secondary | PFS - Time to Event | PFS was defined as the time from start of study treatment to investigator assessed disease progression, or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to RECIST. Median PFS was estimed using the Kaplan-Meier method. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response was defined as the time in months from the day of CR or PR was first noted to the day of progression of disease, death or last follow-up. Median duraiton of response is estimated sing the Kaplan-Meier method. | ITT population; only participants with a response (CR or PR) were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Overall Disease Control | ODC duration was defined as the time in months, from when measurement criteria were first met for CR, PR, or SD (whichever status was recorded first) until the first date when progressive disease or the death from any cause was documented. Data were censored for participants who were lost to follow-up, discontinued prematurely without progression/death, or who reached the end of study without progression. Median ODC was estimated using the Kaplan-Meier method. | ITT population; only participants with an ODC response (CR, PR, or SD) were included in the analysis. | Posted | Median | 95% Confidence Interval | months | Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Percentage of Participants With an Event | Overall survival was defined as the time from start of study treatment to death from any cause. | ITT population | Posted | Number | percentage of participants | Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up) |
|
| |||||||||||||||||||||||||||
| Secondary | OS - Time to Event | OS was defined as the time from start of study treatment to death from any cause. Median OS was estimated using the Kaplan-Meier method. | ITT population | Posted | Median | 95% Confidence Interval | months | Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up) |
|
|
Adverse events (AEs) were reported from the data of first study-drug administration until 28 days after the last study-drug administration.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab + Chemotherapy | Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant. | 9 | 53 | 52 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Inguinal hernia repair | Surgical and medical procedures | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Radiofrequency ablation | Surgical and medical procedures | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Colonoscopy | Surgical and medical procedures | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Cholinergic syndrome | Psychiatric disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | NCI CTC version 3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Paresthesia | Nervous system disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Eye disorder | Eye disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Surgical and medical procedures | Surgical and medical procedures | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Vascular disorders | Vascular disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Hepatobiliary disorders | Hepatobiliary disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Bleeding/hemorrhage (all epistaxis) | Respiratory, thoracic and mediastinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Gastro-intestinal perforation | Gastrointestinal disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Wound healing complication | Injury, poisoning and procedural complications | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | NCI CTC version 3.0 | Non-systematic Assessment |
| |
| Thromboembolism | Vascular disorders | NCI CTC version 3.0 | Non-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 the 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-LaRoche | 800-821-8590 | genentech@druginfo.com |
| 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 |
| 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 |
Not provided
Not provided
|
|
|
|
|
|
|