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The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Hoffmann-La Roche | INDUSTRY |
| International Drug Development Institute | OTHER |
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Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.
Due to greater patient convenience and favorable toxicity profiles, clinical practice has seen an increased use of the combinations of capecitabine with oxaliplatin (CAPOX) and capecitabine with irinotecan (CAPIRI). Given the data documenting the improved efficacy for 5-FU based chemotherapy in combination with bevacizumab, it is important to investigate the potential advantages of adding this agent to regimens containing capecitabine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 7.5 mg/kg IV Day 1 every 21 days for eight cycles* *For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| One-year Progression-free Survival (PFS) | Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen. | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. | |
| Toxicity - Adverse Events | Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman Wolmark, MD | NSABP Foundation Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NSABP Operations Center | Pittsburgh | Pennsylvania | 15212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine, Oxaliplatin, Bevacizumab | |
| FG001 | Capecitabine, Irinotecan, Bevacizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Protocol Therapy (8 Cycles) |
|
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|
| Oxaliplatin | Drug | 130 mg/m2 IV Day 1 every 21 days for eight cycles |
|
|
| Capecitabine | Drug | 850 mg/m2 po BID Days 1-14 every 21 days for eight cycles*# *For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID |
|
|
| Irinotecan | Drug | 200 mg/m2 IV Day 1 every 21 days for eight cycles |
|
|
| Overall Survival | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. |
| Duration of Response | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine, Oxaliplatin, Bevacizumab | |
| BG001 | Capecitabine, Irinotecan, Bevacizumab | |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | One-year Progression-free Survival (PFS) | Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen. | Primary outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen. | Posted | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. |
|
| ||||||||||||||||||||||
| Secondary | Objective Response Rate | Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen. | Posted | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. |
|
| |||||||||||||||||||||||
| Secondary | Toxicity - Adverse Events | Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen. | Posted | Assessments before each cycle of chemotherapy, after every third dose of bevacizumab (if given alone), and final adverse event assessment 3 months after the last dose of bevacizumab |
|
| |||||||||||||||||||||||
| Secondary | Overall Survival | Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen. | Posted | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. |
|
| |||||||||||||||||||||||
| Secondary | Duration of Response | Outcome measure was not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen. | Posted | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. |
|
|
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Adverse events were not assessed due to early study closure. The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
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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 | Capecitabine, Oxaliplatin, Bevacizumab | 0 | 0 | 0 | 0 | |||
| EG001 | Capecitabine, Irinotecan, Bevacizumab | 0 | 0 | 0 | 0 |
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The study was closed early due to low enrollment and new information regarding the benefit of the study regimen.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Gosik | NSABP Foundation, Inc. | 412-330-4692 | diana.gosik@nsabp.org |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| D003110 | Colonic 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 |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D000077146 | Irinotecan |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| 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 |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
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| >=65 years |
|
| Male |
|