Salvage chemotherapy with daily, low, continuously administered dose of capecitabine and proton-pump inhibitors in advanced gastro-intestinaltumours

• Conditions: Patients with gastrointestinal malignancies ineligible for conventional chemotherapy; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001096-20-IT
• Lead Sponsor: Department of Molecular and Clinical Medicine; Sapienza University of Rome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-31
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

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

Inclusion Criteria

1. pre-treated patients with advanced gastro-intestinal tumours 2. performance status (ECOG) =2
3. life espectancy > 3 months
4. adequate organ (liver, kidney, heart and bone marrow) function 5. patients must sign the consent form prior to registration
6. patients must be accessible for treatment and follow up
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 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

1. Gastrointestinal tumours that can be treated with standard treatments
2. Cardiovascular or CNS disease.
3. Previously untreated CNS metastases.
4. Pregnant or breast-feeding patients.
5. Organ dysfunctions that usually hinder the use of cytotoxic drugs 6. Substance abuse and any other condition which may interfere with patient's participation in the study or evaluation of study results

Study & Design

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