patients with colorectal carcinoma compared to patients with normal LDH serum levels

• Conditions: patients treated with first-line chemotherapy and bevacizumab will be prospectively stratified according to LDH serum levels; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005048-46-IT
• Lead Sponsor: Fondazione GISCAD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-06
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: -comparison between response rate according to the RECIST criteria and the criteria defined by Chun (Jama 2009)<br>-evaluation of serum IL-8, bFGF, HGF, PlGF, SDF-1, MCP-3 as a marker of early progression<br>-Progression free survival (to ascertain whether bevacizumab in combination with chemotherapy could determine an improved progression survival in patients with high serum LDH levels compared to patients with normal LDH serum levels;Primary end point(s): Response Rate;Timepoint(s) of evaluation of this end point: Response rate will be evaluated every 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): comparison between response rate according to the RECIST criteria and the criteria defined by Chun (Jama 2009);Timepoint(s) of evaluation of this end point: according to the RECIST criteria and those defined by Chun (JAMA 2009)