Patients with gastrointestinal malignancies ineligible for conventional chemotherapy
Conditions
Interventions
Trade Name: Pariet
Product Name: Pariet
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: RABEPRAZOLE
CAS Number: 117976-89-3
Current Sponsor code: 1169/2013
Concentration unit: mg/kg milligram(
Sponsors
Department of Molecular and Clinical Medicine; "Sapienza" University of Rome
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a single centre, open label, randomized fase II study to determine safety and activity of a combination of the PPI Rabeprazolo (1.5 mg/kg) and mCAP (1500 mg/die) compared to mCAP.;Secondary Objective: To evaluate the clinical benefit rate (CBR), defined as the sum of complete responses (CR), partial responses (PR) and prolonged stabilization of disease (PSD), ie, lasting = 24 weeks;Primary end point(s): 1. 3-months progression-free survival (PFS).PFS is defined as the interval from the first dose of study drug to the date of the first documented disease progression or death for any reason, with censoring at the date of last contact for alive patients. 2. Safety (CTCAE v.4.03);Timepoint(s) of evaluation of this end point: 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): evaluate the clinical benefit rate, overall survival (OS), the pharmacokinetics of capecitabine monotherapy and in combination with rabeprazole;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactMedical Oncology
Sant'Andrea Hospital
Outcome results
None listed