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

Phase 4

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: 5-Fluorouracil; Drug: Bevacizumab; Drug: Irinotecan; Drug: Oxaliplatin

• Registration Number: NCT02582970
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2007-10
• Study Completion: 2008-04
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-21
• Status Verified: 2017-01
• Results First Submitted: 2017-01-18
• Results First Submitted QC: 2017-01-18
• Last Update Submitted: 2017-01-18
• Results First Posted: 2017-03-09
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Previously untreated metastatic colon or rectal cancer
• Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab + Chemotherapy	Bevacizumab	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.
Bevacizumab + Chemotherapy	Oxaliplatin	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.
Bevacizumab + Chemotherapy	5-Fluorouracil	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.
Bevacizumab + Chemotherapy	Irinotecan	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events	Baseline up to approximately 3 years	An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Disease Progression or Death	Baseline up to approximately 3 years	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).
Percentage of Participants Who Died	Baseline up to approximately 3 years
Progression-Free Survival Time	Baseline up to approximately 3 years	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.
Duration of Survival	Baseline up to approximately 3 years	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.
Number of Participants With Best Overall Response	Baseline up to approximately 3 years	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.
Mean Direct Medical Cost for Cancer Related Medical Care Utilization	Baseline up to approximately 3 years	Direct medical cost included cost of out-patient consultation and cost of hospitalization.