Clinical trial NCT00577031: OBELIX Study: A Study of Avastin (Bevacizumab) in Combination With XELOX in Patients With Metastatic Cancer of the Colon or Rectum.
Official title: Open-label, Efficacy and Safety Study of Bevacizumab (Avastin®) in Combination With XELOX (Oxaliplatin Plus Xeloda®) for the First-line Treatment of Patients With Metastatic Cancer of the Colon or Rectum - 'OBELIX'
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will evaluate the efficacy and safety of a first-line regimen of Avastin and XELOX (oxaliplatin + Xeloda) in patients with metastatic cancer of the colon or rectum. Patients will receive 21-day cycles of treatment, comprising Avastin 7.5mg/kg iv on day 1, oxaliplatin 130mg/m2 iv on day 1, and Xeloda 1000mg/m2 po twice daily on days 1-14, for a maximum of 6 months. Patients with stable disease or complete or partial response may continue on Avastin therapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* locally advanced or metastatic colorectal cancer;
* no previous treatment with chemotherapy for metastatic disease;
* at least one measurable lesion.

Exclusion Criteria:

* radiotherapy to any site within 4 weeks before study;
* untreated brain metastases or primary brain tumors;
* clinically significant cardiovascular disease;
* chronic daily treatment with high dose aspirin (\>325 mg/day);
* other co-existing malignancies or malignancies diagnosed within last 5 years.

Primary outcomes:
measure: Progression-Free Survival (PFS): Percentage of Participants With Progressive Disease or Death
timeFrame: Baseline and Day 1 of every cycle until disease progression or death up to 5 years
measure: PFS: Time to Event
timeFrame: Baseline and Day 1 of every cycle until disease progression or death up to 5 years
Secondary outcomes:
measure: Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Among Participants in the ITT Population Who Had at Least 1 Post-Baseline Assessment
timeFrame: Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years
measure: Percentage of Participants With a CR or PR Among Participants in the ITT Population
timeFrame: Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years
measure: Time to CR or PR Overall Response - Time to Event
timeFrame: Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years
measure: Percentage of Participants With a Best Overall Response of CR or PR During First Line Treatment
timeFrame: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years
measure: Duration of Overall Response Among Participants Whose Best Response Was CR or PR During First Line Treatment - Time to Event
timeFrame: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years
measure: Percentage of Participants With a Stable Response During First Line Treatment
timeFrame: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years
measure: Duration of Stable Response
timeFrame: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years
measure: Percentage of Participants With Treatment Failure
timeFrame: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years
measure: Time to Treatment Failure
timeFrame: Baseline, every 3 weeks (every cycle) to disease progression or death up to 5 years
measure: Overall Survival: Percentage of Participants That Died Due to Any Cause
timeFrame: Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years
measure: Overall Survival: Time to Event
timeFrame: Baseline, Day 1 of every cycle to end-of-treatment, every 3 months during longer-term follow-up, or to death due to any cause up to 5 years
measure: Percentage of Participants Undergoing Surgical Intervention With Residual Disease Status Post-surgery
timeFrame: At surgery, at least 6 to 8 weeks after last dose of bevacizumab up to 5 years
measure: Percentage of Participants With Best Overall Response of CR or PR by Kirsten Rat Sarcoma Viral Oncogene Homolog (K-Ras)/V-Raf Murine Sarcoma Viral Oncogene Homolog B (B-Raf) Mutation Status
timeFrame: Baseline, every 9 weeks (every 3 cycles) until end of treatment, disease progression, or withdrawal up to 5 years
measure: European Quality of Life 5 Dimension (EQ-5D) Raw-Index Score
timeFrame: Baseline, every 9 weeks (every 3 cycles), at end-of-treatment up to 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
city: Brescia
country: Italy
city: Cagliari
country: Italy
city: Cagliari
country: Italy
city: Caserta
country: Italy
city: Catanzaro
country: Italy
city: Cefalu
country: Italy
city: Fano
country: Italy
city: Firenze
country: Italy
city: Frattaminore
country: Italy
city: Grosseto
country: Italy
city: Ivrea
country: Italy
city: Latisana
country: Italy
city: Lecce
country: Italy
city: Legnago
country: Italy
city: Legnano
country: Italy
city: Macerata
country: Italy
city: Napoli
country: Italy
city: Negrar
country: Italy
city: Orbassano
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Reggio Calabria
country: Italy
city: Reggio Emilia
country: Italy
city: Rionero in Vulture
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Salerno
country: Italy
city: San Giovanni Rotondo
country: Italy
city: Sondrio
country: Italy
city: Taormina
country: Italy
city: Torino
country: Italy
city: Torino
country: Italy
city: Verbania
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Antonuzzo L, Giommoni E, Pastorelli D, Latiano T, Pavese I, Azzarello D, Aieta M, Pastina I, Di Fabio F, Bertolini A, Corsi DC, Mogavero S, Angelini V, Pazzagli M, Di Costanzo F. Bevacizumab plus XELOX as first-line treatment of metastatic colorectal cancer: The OBELIX study. World J Gastroenterol. 2015 Jun 21;21(23):7281-8. doi: 10.3748/wjg.v21.i23.7281.