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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02582970

Enrollment

Registered

2015-10-21

Start date

2005-05-31

Completion date

2008-04-30

Last updated

2017-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

DRUG5-Fluorouracil

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.

DRUGBevacizumab

Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.

DRUGIrinotecan

Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.

DRUGOxaliplatin

Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Percentage of Participants Who Died	Baseline up to approximately 3 years	—
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.
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).
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.
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.

Countries

Taiwan

Participant flow

Participants by arm

Arm	Count
Bevacizumab + Chemotherapy Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.	40
Total	40

Baseline characteristics

Characteristic	Bevacizumab + Chemotherapy
Age, Continuous	58.6 years STANDARD_DEVIATION 13.18
Sex: Female, Male Female	15 Participants
Sex: Female, Male Male	25 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	40 / 40
serious Total, serious adverse events	14 / 40

Outcome results

Primary

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.