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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

5-Fluorouracil

Bevacizumab

Irinotecan

Oxaliplatin

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab + Chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Who Died

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.

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).

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.

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.

Mean Direct Medical Cost for Cancer Related Medical Care Utilization

Direct medical cost included cost of out-patient consultation and cost of hospitalization.

Full Information

NCT ID

NCT02582970

First Posted

October 12, 2015

Last Updated

January 18, 2017

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02582970

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab + Chemotherapy

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

5-Fluorouracil

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Participants With Adverse Events

Description

An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.

Time Frame