Antiangiogenic activity of metronomic therapy with capecitabine in metastatic solid tumors of gastrointestinal tract: a phase II study - Metronomic capecitabine
- Conditions
- Metastatic solid tumors of gastrointestinal tractMedDRA version: 12.1Level: HLTClassification code 10025680Term: Malignant miscellaneous gastrointestinal neoplasms
- Registration Number
- EUCTR2009-009919-21-IT
- Lead Sponsor
- ISTITUTO DERMOPATICO IMMACOLATA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Histologically or cytologically confirmed colorectal or gastric or colangio- or pancreatic carcinoma metastastic or locally advanced disease, not amenable to surgery. At least 1 prior chemotherapy regimen for metastatic disease for patients with ECOG PS 0-1 No prior chemotherapy regimen is scheduled for patients with an ECOG performance status of 2 At least one measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors RECIST criteria Patients over 18 ECOG Performance Status < 2 Signed informed consent.Consenso informato scritto
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Life expectancy < 3 months serious and uncontrolled systemic co-morbidities second malignancy (except adequately treated in situ carcinoma of the cervix or non melanomic skin cancer) Patients who are pregnant or breast-feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: progression free survival (TTP); Serum levels of interleukins, cytochines, MIP, MCP, TNF, G-CSF, GM-CSF, FGF, VEGF in relationship with the treatment;Secondary Objective: Objective responses; toxicity evaluation; quality of life (QLQ-C30 EORTC questionnaire) ; overall survival; DPD test;Primary end point(s): progression free survival (TTP); Serum level of interleukins, cytochines, MIP, MCP, TNF, G-CSF, GM-CSF, FGF, VEGF in relationship with the treatment
- Secondary Outcome Measures
Name Time Method