Clinical trial NCT01181609: A Study of Avastin (Bevacizumab) Combined With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Official title: An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic colon or rectal cancer, progressing or relapsing after first-line treatment;
* Women of childbearing potential must use adequate contraception up to at least 6 months after the last dose of bevacizumab.

Exclusion Criteria:

* Patients with metastatic colon or rectal cancer scheduled for a first-line systemic treatment;
* Untreated brain metastases, spinal cord compression or primary brain tumours;
* Pregnant or lactating women;
* 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.

Primary outcomes:
measure: Percentage of Participants Achieving Overall Disease Control (ODC)
timeFrame: Baseline, after every other cycle to disease progression or death (Maximum of 52.5 months follow-up)
Secondary outcomes:
measure: Percentage of Participants Achieving a Best Overall Response of CR or PR
timeFrame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
measure: Progression-Free Survival (PFS) - Percentage of Participants With an Event
timeFrame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
measure: PFS - Time to Event
timeFrame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
measure: Duration of Response
timeFrame: Baseline, every cycle until progression or death (Maximum of 52.5 months follow-up)
measure: Duration of Overall Disease Control
timeFrame: Baseline, every cycle until progression or death. (Maximum of 52.5 months follow-up)
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: Baseline, every cycle to progression or death (Maximum of 52.5 months follow-up)
measure: OS - Time to Event
timeFrame: Baseline, every cycle to progression or death. (Maximum of 52.5 months follow-up)
Other outcomes:
Locations:
city: Angers
country: France
city: Besancon
country: France
city: Boulogne-billancourt
country: France
city: Colmar
country: France
city: Dijon
country: France
city: La Roche Sur Yon
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Neuilly Sur Seine
country: France
city: Nice
country: France
city: Paris
country: France
city: Pierre Benite
country: France
city: Reims
country: France
city: Saint Herblain
country: France
city: Saint-cloud
country: France
city: Toulouse
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: