Colorectal Neoplasms
Conditions
Keywords
NSABP, bevacizumab, capecitabine, oxaliplatin, irinotecan, rectal cancer, colon cancer, colorectal cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGBevacizumab
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.
DRUGOxaliplatin
130 mg/m2 IV Day 1 every 21 days for eight cycles
DRUGCapecitabine
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
DRUGIrinotecan
200 mg/m2 IV Day 1 every 21 days for eight cycles
Sponsors
Genentech, Inc.
Hoffmann-La Roche
International Drug Development Institute
NSABP Foundation Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathological diagnosis of colon or rectal cancer from either the colon or rectum or a metastatic site (beyond the colon or rectum) * Evidence of adequate organ function (such as liver, kidneys, etc.)
Exclusion criteria
* Diagnosis of anal cancer * Patients who are candidates for surgery * Patients who have received previous treatments * Pregnant or lactating women * History of chronic disease(s) or other serious medical conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year Progression-free Survival (PFS) | Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. | 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. |
Secondary
| Measure | 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capecitabine, Oxaliplatin, Bevacizumab | 4 |
| Capecitabine, Irinotecan, Bevacizumab | 3 |
| Total | 7 |
Baseline characteristics
| Characteristic | Capecitabine, Irinotecan, Bevacizumab | Capecitabine, Oxaliplatin, Bevacizumab | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Continuous | 63.0 years STANDARD_DEVIATION 13.2 | 65.8 years STANDARD_DEVIATION 9 | 64.6 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 3 participants | 4 participants | 7 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Population: 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.
Secondary
Duration of Response
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Population: 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.
Secondary
Objective Response Rate
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Population: 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.
Secondary
Overall Survival
Time frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met.
Population: 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.
Secondary
Toxicity - Adverse Events
Time frame: 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
Population: 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.