Clinical trial NCT00940303: OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer
Official title: An Open Label, Single-arm, Phase II Study to Evaluate the Efficacy and the Feasibility of Bevacizumab (Avastin) Based on a FOLFOXIRI Regimen Until Progression in Patients With Previously Untreated Metastatic Colorectal Carcinoma(OPAL-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-07-16
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-70 years of age;
* metastatic colorectal cancer scheduled for standard first line chemotherapy;
* at least 1 measurable lesion;
* ECOG performance score of 0 or 1.

Exclusion Criteria:

* prior chemotherapy for metastatic colorectal cancer;
* prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy completed within 6 months prior to study entry;
* concomitant malignancies other CRC;
* history or evidence of CNS disease unrelated to cancer.

Primary outcomes:
measure: Progression-free survival
timeFrame: assessed every 8 weeks up to week 102, 3-monthly during follow-up
Secondary outcomes:
measure: Overall survival; proportion of patients achieving R0 resectability; objective response rate (complete response [CR] and partial response [PR]); proportion of patients completing 12 cycles of chemotherapy.
timeFrame: assessed every 4 weeks up to week 102 and at the end of follow-up period
measure: Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.
timeFrame: Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Celle
country: Germany
city: Celle
country: Germany
city: Dessau-Roßlau
country: Germany
city: Freiburg
country: Germany
city: Fulda
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Leer
country: Germany
city: Magdeburg
country: Germany
city: Magdeburg
country: Germany
city: Nürnberg
country: Germany
city: Stade
country: Germany
city: Villingen-Schwenningen
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Stein A, Atanackovic D, Hildebrandt B, Stubs P, Brugger W, Hapke G, Steffens CC, Illerhaus G, Bluemner E, Stohlmacher J, Bokemeyer C. Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer. Br J Cancer. 2015 Sep 15;113(6):872-7. doi: 10.1038/bjc.2015.299. Epub 2015 Sep 3.