First-line Irinotecan, Lederfolin and 5FU (FOLFIRI) and Bevacizumab in Patients With Advanced Colorectal Cancer
CENTRAL
First-line FOLFIRI and Bevacizumab in Patients With Advanced Colorectal Cancer Prospectively Stratified According to Serum LDH
1 other identifier
interventional
85
1 country
13
Brief Summary
Bevacizumab in combination with chemotherapy represents a standard of care for first-line treatment in patients with advanced colorectal cancer. Molecular predictive factors for bevacizumab efficacy have not yet been identified therefore selection of patients more likely to benefit from such a treatment approach is not possible. Retrospective analyses suggested that LDH serum levels may influence the clinical activity of anti-angiogenetic drugs. Primary aim of our clinical trial will be to prospectively ascertain whether bevacizumab in combination with chemotherapy has an improved clinical activity in patients with high LDH serum levels compared to patients with normal LDH serum levels
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2013
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJuly 15, 2015
July 1, 2015
2 years
March 21, 2013
July 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response Rate
Response rate to ascertain whether bevacizumab in combination with chemotherapy could determine an improved response rate in patients with high LDH serum levels compared to patients with normal LDH serum levels
RR will be evaluated every 12 weeks for 24 months
Secondary Outcomes (2)
Progression free survival
18 months: time from the start of the treatment until PD or death
evaluation of serum IL-8, bFGF, HGF, PlGF, SDF-1, MCP-3
every 12 weeks for 18 months
Other Outcomes (1)
RECIST criteria and those defined by Chun
every12 weeks for 18 months
Study Arms (1)
Bevacizumab and FOLFIRI
OTHERBevacizumab 5 mg/kg d1 q14 in combination with FOLFIRI (Irinotecan, leucovorin, 5FU I.V.bolus and 5FU I.V. c.i.)
Interventions
The CENTRAL trial is a biologically enriched prospective phase II clinical trial in which patients treated with first-line modified FOLFIRI and bevacizumab will be prospectively stratified according to LDH serum levels. After written informed consent patients will be enrolled. Patients will be considered evaluable for study aim if response rate was radiologically evaluated at least once during treatment course. Treatment will be administered until progression, patients' withdrawal of consent, unacceptable toxicity
Eligibility Criteria
You may qualify if:
- Written informed consent
- No prior treatment for advanced disease (adjuvant therapy allowed)
- age \< 75 years \< 18 years
- Histologically/cytologically confirmed advanced, colorectal cancer
- At least one lesion measurable with CT or MRI scan
- Performance Status (ECOG) 0-1 at study entry)
- Life expectancy of at least 6 months
- Neutrophils count =/\> 1.5 x 109/L, platelets count =/\> 100 x 109/L, HGB =/\> 10 g/dL
- total bilirubin \< 1.5 x UNL • SGOT and SGPT =/\< 2.5 x UNL (=/\< 5 x UNL in patients with liver metastases)
- Creatinine \< 1.5 x UNL
You may not qualify if:
- CNS metastases
- Severe cardiovascular disease
- Uncontrolled infections
- Radiotherapy within 4 weeks of study entry
- Any experimental drug administered within 4 weeks of study entry
- Known hypersensitivity to study drug
- Known drugs or alcohol abuse
- Pregnant or lactating women (serum Betahcg test)
- Other tumours, except in situ melanoma or cervix cancer if radically removed
- Incapability to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
A.O. Universitaria - Ospedali Riuniti
Ancona, Ancona, 60100, Italy
A.O. Ospedale G.Rummo
Benevento, Benevento, 82100, Italy
A.O. Treviglio-Caravaggio, P.le Ospedale n1
Treviglio, Bergamo, 24047, Italy
Istituto Ospedaliero Fondazione Poliambulanza
Brescia, Brescia, 25124, Italy
Ospedale Civile
Carrara, Massa Carrara, 54033, Italy
Ospedale Maggiore Policlinico
Milan, Milano, 20122, Italy
IRCCS Istituto Europeo di Oncologia
Milan, Milano, 20141, Italy
A.O. Ospedale S.Paolo
Milan, MI, 20100, Italy
Istituto Oncologico Veneto
Padua, PD, 35124, Italy
Ospedale Santa Croce
Fano, PS, 61032, Italy
Azienda Ospedaliera San Carlo
Potenza, PZ, 85100, Italy
Università Policlinico Umberto I
Roma, RM, 00186, Italy
A.O. S.Giovanni Calabita Fatebenefratelli
Roma, Roma, 00186, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stefano Cascinu, PhD
GISCAD Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2013
First Posted
May 15, 2013
Study Start
May 1, 2013
Primary Completion
May 1, 2015
Study Completion
July 1, 2015
Last Updated
July 15, 2015
Record last verified: 2015-07