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possible lack of efficacy
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| Name | Class |
|---|---|
| Rhode Island Hospital | OTHER |
| The Miriam Hospital | OTHER |
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Bevacizumab given at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression.Primary Objective: To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer.
26 patients with advanced colorectal cancer will be given Bevacizumab at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease progression
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression. Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intervention | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab | To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3 | every 3 weeks until patient comes off study (progressive disease), for up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| howard p safran, MD | lifespan Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Providence | Rhode Island | 02906 | United States |
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5 Patients were enrolled at The Miriam and Rhode Island Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | Panitumumab and Bevacizumab | Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression. Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression. Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab | To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3 | Posted | Number | participants | every 3 weeks until patient comes off study (progressive disease), for up to 2 years |
|
|
from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)
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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 | Intervention | Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression. Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia (3), nausea(3), vomiting(2), weakness(3), confusion(1), hypok(3), hypophos(3), hypoca(3) | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard Safran, MD | BrUOG | 4018633000 | Hsafran@lifespan.org |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D000068258 | Bevacizumab |
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 1 |
| 5 |
| 5 |
| 5 |
| Rash | Investigations | Systematic Assessment |
|
| Skin Redness | Investigations | Systematic Assessment |
|
| Constipation | Investigations | Systematic Assessment |
|
| Yeast Infection | Investigations | Systematic Assessment |
|
| Alk Phos | Investigations | Systematic Assessment |
|
| AST | Investigations | Systematic Assessment |
|
| dehydration | Investigations | Systematic Assessment |
|
| abd pain | Investigations | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |