Overview

This trial has been completed.

Condition colorectal cancer
Treatments folfiri, xelox, bevacizumab [avastin], mfolfox6
Phase phase 4
Sponsor Hoffmann-La Roche
Start date June 2012
End date September 2016
Trial size 128 participants
Trial identifier NCT01588990, ML25753

Summary

This open-label, prospective, single-arm, multicenter study will evaluate the relationship of the markers of inflammation and progression-free survival in patients with previously untreated metastatic colorectal cancer. The study consists of two phases: Phase A treatment: XELOX plus Avastin (bevacizumab), or mFOLFOX6 plus Avastin administered until first disease progression. Patients will then continue with Phase B treatment: FOLFIRI plus Avastin until second disease progression. The anticipated time on study treatment is 4 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bevacizumab [avastin]
5.0 mg/kg intravenously on Day 1 every 2 weeks until 1st disease progression
mfolfox6
Oxaliplatin 85 mg/m2 intravenously on Day 1, leucovorin 400 mg/m2 intravenously on Day 1, fluorouracil 400 mg/m2 on Day 1, fluorouracil 2400 mg/m2 intravenous infusion on Day 1 every two weeks until 1st disease progression
(Experimental)
xelox
Oxaliplatin 130 mg/m2 intravenously on Day 1, capecitabine 1000 mg/m2 orally twice daily on Days 1-14 of every 3 weeks cycle until 1st disease progression
bevacizumab [avastin]
7.5 mg/kg intravenously on Day 1 of every 3 weeks cycle until 1st disease progression
(Experimental)
folfiri
Irinotecan 180 mg/m2 intravenously on Day 1, leucovorin 400 mg/m2 on Day 1, fluorouracil 400 mg/m2 on Day 1, fluorouracil 2400 mg/m2 intravenous infusion on Day 1 every 2 weeks until 2nd disease progression
bevacizumab [avastin]
5.0 mg/kg intravenously on Day 1 every 2 weeks until 2nd disease progression

Primary Outcomes

Measure
Prognostic value of the host inflammatory response as assessed by the neutrophil/lymphocyte ratio on progression-free survival
time frame: Up to 4 years

Secondary Outcomes

Measure
Progression-free survival during Phase A
time frame: Up to 4 years
Progression-free survival during Phase B
time frame: Up to 4 years
Time to failure of strategy
time frame: Up to 4 years
Duration of disease control
time frame: Up to 4 years
Overall survival from the start of treatment to study completion
time frame: Up to 4 years
Survival beyond 1st progression
time frame: Up to 4 years
Overall survival during Phase B
time frame: Up to 4 years
Overall response rate
time frame: Up to 4 years
Rate of liver resection
time frame: Up to 4 years
Safety: incidence of adverse events
time frame: Up to 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Resected primary tumor patients, and patients with primary tumor in situ: - Adult patients, >/= 18 years of age - Previously untreated metastatic colorectal cancer and not a candidate for curative resection - WHO performance status of 0-1 - Life expectancy of >/= 3 months - Eligible for XELOX, mFOLFOX6, FOLFIRI and Avastin treatment in accordance with local standards of care and pharmaceutical benefits scheme Additional inclusion criteria for patients with primary tumor in situ: - Intact primary tumor of the colon or the rectum not requiring surgical intervention prior to study start - Minimal or asymptomatic primary tumor Exclusion Criteria: Resected primary tumor patients, and patients with primary tumor in situ: - Previous chemotherapy for metastatic colorectal cancer - Previous neoadjuvant or adjuvant chemotherapy less than 6 months prior to study start - Radiotherapy within 28 days prior to enrolment or not recovered from a radiotherapy - History of non-colorectal cancer (patients are eligible if disease-free for more than 5 years and the risk of recurrence is deemed low) - Presence of active inflammatory bowel disease - History of gastrointestinal perforations - Peritoneal disease - History of significant bleeding event - Significant vascular disease - Peripheral arterial thrombosis or other thrombotic event within 6 months before study start Additional exclusion criteria for patients with primary tumor in situ: - Prior endoscopic management of the current tumor - Acute diverticulitis - Presence of intra-abdominal abscess - Active gastroduodenal ulcer

Additional Information

Official title An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin) [ASCENT]
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.