A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum

Study Overview
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Brief Summary
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This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.

Official Title
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An Expanded Access Program of AvastinTM (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: 5-Fluorouracil
* Drug: Bevacizumab
* Drug: Irinotecan
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously untreated metastatic colon or rectal cancer Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment Exclusion Criteria: Prior chemotherapy for metastatic colon or rectal cancer Planned radiotherapy for underlying disease Central nervous system metastases Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab + Chemotherapy<br>Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study. | Drug: 5-Fluorouracil<br>* Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.<br>Drug: Bevacizumab<br>* Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.<br>* Other names: Avastin;Drug: Irinotecan<br>* Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.<br>Drug: Oxaliplatin<br>* Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events | An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. | Baseline up to approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Died |  | Baseline up to approximately 3 years | 
| Duration of Survival | Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis. | Baseline up to approximately 3 years | 
| Percentage of Participants With Disease Progression or Death | Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL). | Baseline up to approximately 3 years | 
| Progression-Free Survival Time | Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis. | Baseline up to approximately 3 years | 
| Number of Participants With Best Overall Response | The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD. | Baseline up to approximately 3 years | 
| Mean Direct Medical Cost for Cancer Related Medical Care Utilization | Direct medical cost included cost of out-patient consultation and cost of hospitalization. | Baseline up to approximately 3 years |