Colorectal Cancer
Conditions
Brief summary
This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
Interventions
DRUGcapecitabine [Xeloda]
1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
DRUGbevacizumab [Avastin]
5 mg/kg taken intravenously on Day 1 of each 2 week cycle
DRUGoxaliplatin
85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
DRUGirinotecan
135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Sponsors
Hoffmann-La Roche
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
* Adult patients, ≥18 years of age * Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease * ≥1 measurable target lesion * Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Exclusion criteria
* Prior systemic therapy for advanced or metastatic disease * History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix * Clinically significant cardiovascular disease * Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents * Chronic daily treatment with \>325 mg/day aspirin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) in U.S. Patients Only | From first patient enrolled up to approximately 48 months | PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XELOX + Bevacizumab (Q2W) Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cylce, and oxaliplatin intravenously at a dose of 85 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment. | 21 |
| XELIRI + Bevacizumab (Q2W) Capecitabine orally at a dose of 1000 mg/m2 twice daily, bevacizumab intravenously at a dose of 5 mg/kg on Day 1 of each cycle, and irinotecan intravenously at a dose of 135 mg/m2 on Day 1 following bevacizumab for the first 12 cycles only. Each cycle is 14 days consisting of 7 days of treatment followed by 7 days without treatment. | 20 |
| Total | 41 |
Baseline characteristics
| Characteristic | XELOX + Bevacizumab (Q2W) | XELIRI + Bevacizumab (Q2W) | Total |
|---|---|---|---|
| Age, Continuous | 63.9 years STANDARD_DEVIATION 12.06 | 60.6 years STANDARD_DEVIATION 9.89 | 62.3 years STANDARD_DEVIATION 11.04 |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 17 / 19 | 19 / 20 |
| serious Total, serious adverse events | 4 / 19 | 7 / 20 |
Outcome results
Primary
Progression-free Survival (PFS) in U.S. Patients Only
PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.
Time frame: From first patient enrolled up to approximately 48 months
Population: This study was terminated early because interim data from a predecessor study invalidated the scientific rationale that provided justification for the conduct of this study. Efficacy analyses were not performed.