NCT00642577

Brief Summary

This 2 arm study will assess the efficacy and safety of Avastin in combination with irinotecan + 5-fluorouracil/folinic acid, versus irinotecan + fluorouracil/folinic acid alone, as first line treatment in Chinese patients with metastatic colorectal cancer. Patients will be randomized 2:1 to receive 6-weekly cycles of Avastin (5mg/kg iv every 2 weeks) + irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks, or 6-weekly cycles of irinotecan 125mg/m2 iv / leucovorin 20mg/m2 iv / fluorouracil 500mg/m2 iv weekly for 4 weeks. The anticipated time on study treatment is until disease progression, and the sample size is 100-500 individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P25-P50 for phase_3 colorectal-cancer

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

3.4 years

First QC Date

March 19, 2008

Last Update Submit

December 21, 2022

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival.

    6 months

Secondary Outcomes (2)

  • Overall response rate, time to response, duration of response, overall survival.

    Event driven

  • AEs, laboratory tests

    Throughout study

Study Arms (2)

1

EXPERIMENTAL
Drug: bevacizumab [Avastin]Drug: irinotecanDrug: leucovorinDrug: fluorouracil

2

ACTIVE COMPARATOR
Drug: irinotecanDrug: leucovorinDrug: fluorouracil

Interventions

bevacizumab [Avastin]DRUG

5mg/kg iv every 2 weeks

1
irinotecanDRUG

125mg/m2 iv weekly for 4 weeks of each 6 week cycle

12
leucovorinDRUG

20mg/m2 iv weekly for 4 weeks of each 6 week cycle

12
fluorouracilDRUG

500mg/m2 iv weekly for 4 weeks of each 6 week cycle

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, \>=18 years of age;
  • histologically confirmed adenocarcinoma of the colon or rectum, with metastatic disease;
  • \>=1 measurable lesion;
  • ECOG performance status of \<=1.

You may not qualify if:

  • prior systemic therapy for advanced or metastatic disease;
  • adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months;
  • other malignancy within past 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
  • clinically significant cardiovascular disease in past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Beijing, 100021, China

Location

Unknown Facility

Beijing, 100036, China

Location

Unknown Facility

Beijing, 100071, China

Location

Unknown Facility

Chongqing, 400042, China

Location

Unknown Facility

Guangdong, 510515, China

Location

Unknown Facility

Guangzhou, 510060, China

Location

Unknown Facility

Nanjing, 210002, China

Location

Unknown Facility

Qingdao, 266003, China

Location

Unknown Facility

Shanghai, 200003, China

Location

Unknown Facility

Shanghai, 200080, China

Location

Unknown Facility

Tianjin, 300060, China

Location

Unknown Facility

Wuhan, 430030, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

BevacizumabIrinotecanLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCamptothecinAlkaloidsHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 25, 2008

Study Start

July 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

December 22, 2022

Record last verified: 2022-12

Locations

CN(12)