Phase II trial of second line therapy with Oxaliplatin and Pemetrexed in patients with advanced pancreatic cancer - Pemetrexed_Oxaliplatino
- Conditions
- Advanced pancreatic cancer patientsMedDRA version: 14.1Level: PTClassification code 10059326Term: Pancreatic carcinoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2006-001272-21-IT
- Lead Sponsor
- AZIENDA OSPEDALIERO-UNIVERSITARIA S. MARIA DELLA MISERICORDIA DI UDINE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Response Rate;Main Objective: Overall Response Rate;Secondary Objective: Time to treatment failure; Tolerability; TTP; Clinical Benefit; Overall Survival.
- Secondary Outcome Measures
Name Time Method