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

Condition(s) targeted: Colorectal Cancer

Intervention: Bevacizumab [Avastin] (Drug); Capecitabine (Drug); Irinotecan (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Chair, Affiliation: Hoffmann-La Roche

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.

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percentage of Participants With Disease Progression or Death

Time to Progression (TTP)

Secondary outcome:

Percentage of Participants Who Died

Overall Survival

Percentage of Participants With Treatment Failure

Time to Treatment Failure

Percentage of Participants With Progression Excluding Deaths

Time to Progression Excluding Deaths

Percentage of Participants With Progression Excluding Deaths Not Related to Underlying Cancer

Time to Progression Excluding Deaths Not Related to Underlying Cancer

Percentage of Participants by Best Overall Response

Percentage of Participants With a Best Overall Response of CR or PR

Percentage of Participants With Stable Disease

Percentage of Participants With Progressive Disease Within 12 Weeks From Start of Treatment

Duration of Overall Response

Duration of Stable Disease (SD)

Duration of Overall Complete Response

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Paola, Calabria 87027, Italy

Benevento, Campania 82100, Italy

Napoli, Campania 80136, Italy

Bologna, Emilia-Romagna 40138, Italy

Carpi, Emilia-Romagna 41012, Italy

Piacenza, Emilia-Romagna 29100, Italy

Latisana, Friuli-Venezia Giulia 33053, Italy

Udine, Friuli-Venezia Giulia 33100, Italy

Latina, Lazio 04100, Italy

Roma, Lazio 00168, Italy

Roma, Lazio 00186, Italy

Brescia, Lombardia 25123, Italy

Busto Arsizio, Lombardia 21052, Italy

Casalpusterlengo, Lombardia 20071, Italy

Cremona, Lombardia 26100, Italy

Gorgonzola, Lombardia 20064, Italy

Lecco, Lombardia 23900, Italy

Legnago, Lombardia 37045, Italy

Mantova, Lombardia 46100, Italy

Milano, Lombardia 20142, Italy

Milano, Lombardia 20133, Italy

Milano, Lombardia 20121, Italy

Milano, Lombardia 20162, Italy

Pavia, Lombardia 27100, Italy

Saronno, Lombardia 21047, Italy

Sondrio, Lombardia 23100, Italy

Treviglio, Lombardia 24047, Italy

Varese, Lombardia 21100, Italy

Ancona, Marche 60121, Italy

Novara, Piemonte 28100, Italy

Torino, Piemonte 10153, Italy

Cagliari, Sardegna 09100, Italy

Catania, Sicilia 95100, Italy

Palermo, Sicilia 90127, Italy

Firenze, Toscana 50139, Italy

Grosseto, Toscana 58100, Italy

Pisa, Toscana 56100, Italy

Prato, Toscana 59100, Italy

Bolzano, Trentino-Alto Adige 39100, Italy

Terni, Umbria 05100, Italy

Camposampiero, Veneto 35012, Italy

Este, Veneto 35042, Italy

Montecchio Maggiore, Veneto 36075, Italy

Negrar, Veneto 37024, Italy

Starting date: June 2005
Last updated: June 2, 2015