Clinical trial NCT00623805: A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer
Official title: A Randomized, Multicenter Phase III Trial to Assess the Efficacy and Safety of Bevacizumab and Capecitabine as Maintenance Treatment, After Initial Combination Treatment With Capecitabine, Oxaliplatin and Bevacizumab in Patients With Metastatic Colorectal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-02-26
Enrollment: 123
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: This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin + Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of 2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease progression. Xeloda was administered at a dose of 1000 mg/m\^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m\^2 intravenously (iv) on day 1 of each cycle, and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥ 18 years of age.
* Histologically confirmed colon or rectal cancer, with unresectable metastatic disease.
* At least 1 measurable lesion.
* Outpatient, with Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.

Exclusion Criteria:

* Previous treatment with Avastin.
* Previous systemic treatment for advanced or metastatic disease.
* clinically significant cardiovascular disease.
* Daily chronic treatment with high doses of aspirin (\> 325 mg/day) or non-steroidal anti-inflammatory drugs.

Primary outcomes:
measure: Progression-free Survival
timeFrame: Baseline to the end of the study (up to 4 years, 2 months)
Secondary outcomes:
measure: Overall Survival
timeFrame: Baseline to the end of the study (up to 4 years, 2 months)
measure: Percentage of Participants With a Complete Response or a Partial Response
timeFrame: Baseline to the end of the study (up to 4 years, 2 months)
measure: Time Until a Complete Response or a Partial Response
timeFrame: Baseline to Month 13
measure: Duration of Response
timeFrame: Baseline to the end of the study (up to 4 years, 2 months)
measure: Percentage of Participants With Metastatic Lesions Previously Considered Inoperable Who Became Operable and Underwent Surgery
timeFrame: Baseline to the end of the study (up to 4 years, 2 months)
measure: Percentage of Participants With a R0 Resection
timeFrame: Baseline to the end of the study (up to 4 years, 2 months)
Other outcomes:
Locations:
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Gaziantep
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Izmir
country: Turkey
city: S?hhiye, ANKARA
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: