Advanced pancreatic cancer patients MedDRA version: 14.1 Level: PT Classification code 10059326 Term: Pancreatic carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ALIMTA*1FL POLV 500MG
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Pemetrexed
Concentration unit: mg milligram(s)
Concentration number: 500-
Trade Name: ELOX
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA S. MARIA DELLA MISERICORDIA DI UDINE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. written informed consent; 2. Histological diagnosis of pancreatic cancer; 3. Advanced disease; 4. At least one measurable lesion (RECIST criteria); 5. Age 18-70 6. ECOG 0-1; 7. Adequate bone marrow, epatic and renal function; 8. Progressive disease to previous chemotherapy with Gemcitabine. Are the trial subjects under 18? no Number of subjects for this age range: 0 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
Exclusion criteria
Exclusion criteria: 1. Previous chemotherapy containing Pemetrexed or Oxaliplatin; 2. Previous or concomitant cancers, except curatively treated cervical carcinoma in situ or non-melanoma skin cancer; 3. Pregnant or lactating women; 4. Peripheral Neuropathy grade >2; 5. concomitant treatment with other sperimental drugs; 6. Medical controindications to chemotherapic treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Response Rate;Main Objective: Overall Response Rate;Secondary Objective: Time to treatment failure; Tolerability; TTP; Clinical Benefit; Overall Survival. | — |
Countries
Italy
Outcome results
None listed