Clinical trial NCT01131078: A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum
Official title: A Randomized, Open-label Study Comparing the Effect of 3 Chemotherapy Regimens Containing Avastin on Time to Disease Progression in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* colon or rectal cancer, with metastases;
* \>=1 measurable lesion.

Exclusion Criteria:

* previous systemic treatment for advanced disease;
* radiotherapy to any site within 4 weeks before study;
* daily aspirin (\>325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration;
* co-existing malignancies or malignancies diagnosed within last 5 years (except basal cell cancer or cervical cancer in situ).

Primary outcomes:
measure: Percentage of Participants With Disease Progression or Death
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Time to Progression (TTP)
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
Secondary outcomes:
measure: Percentage of Participants Who Died
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Overall Survival
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Percentage of Participants With Treatment Failure
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Time to Treatment Failure
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Percentage of Participants With Progression Excluding Deaths
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Time to Progression Excluding Deaths
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Time to Progression Excluding Deaths Not Related to Underlying Cancer
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Percentage of Participants by Best Overall Response
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Percentage of Participants With a Best Overall Response of CR or PR
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Percentage of Participants With Stable Disease
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment
timeFrame: Randomization, Weeks 3, 6 and 9, and 12
measure: Duration of Overall Response
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Duration of Stable Disease (SD)
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death
measure: Duration of Overall Complete Response
timeFrame: Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years
Other outcomes:
Locations:
city: Paola
country: Italy
state: Calabria
city: Benevento
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Carpi
country: Italy
state: Emilia-Romagna
city: Piacenza
country: Italy
state: Emilia-Romagna
city: Latisana
country: Italy
state: Friuli-Venezia Giulia
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Latina
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Brescia
country: Italy
state: Lombardia
city: Busto Arsizio
country: Italy
state: Lombardia
city: Casalpusterlengo
country: Italy
state: Lombardia
city: Cremona
country: Italy
state: Lombardia
city: Gorgonzola
country: Italy
state: Lombardia
city: Lecco
country: Italy
state: Lombardia
city: Legnago
country: Italy
state: Lombardia
city: Mantova
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Saronno
country: Italy
state: Lombardia
city: Sondrio
country: Italy
state: Lombardia
city: Treviglio
country: Italy
state: Lombardia
city: Varese
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Novara
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Cagliari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Firenze
country: Italy
state: Toscana
city: Grosseto
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Prato
country: Italy
state: Toscana
city: Bolzano
country: Italy
state: Trentino-Alto Adige
city: Terni
country: Italy
state: Umbria
city: Camposampiero
country: Italy
state: Veneto
city: Este
country: Italy
state: Veneto
city: Montecchio Maggiore
country: Italy
state: Veneto
city: Negrar
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: