advanced pancreatic cancer MedDRA version: 9.1 Level: LLT Classification code 10033604 Term: Pancreatic cancer
Conditions
Interventions
Trade Name: TORISEL
Product Name: Torisel
Product Code: TORISEL
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TEMSIROLIMUS
CAS Number: 162635-04-3
Concentration unit:
Sponsors
Hellenic Cooperative Oncology Group (HeCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Age 18 years or older 3. Histologic proof of pancreatic cancer 4. Performance status between 50% and 100% on the Karnofsky scale 5. Life expectancy of greater than 12 weeks 6. Prior radiotherapy is allowed except for evaluable sites 7. Measurable or evaluable disease as according to RECIST 8. All females of childbearing potential must have a negative serum or urine pregnancy test obtained within 2 days prior to initiation of treatment 9. WBC>4000/µl, platelets > 100,000/µl and a hemoglobin level > 9.5 g/dl. Adequate baseline hepatic function, defined as a total bilirubin level 60 ml/min. 10 Provision of adequate paraffin-embedded tumor tissue for translational studies and 10 ml peripheral blood for DNA study. 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
Exclusion criteria
Exclusion criteria: 1. Patients with ampullary, periampullary, bile duct cancers or endocrine tumors of the pancreas 2. History of atrial or ventricular arrhythmias and/or history of congestive heart failure, even if medically controlled. History of clinical and electrocardiographically documented myocardial infarction within the last 6 months from study entry 3. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded) 4. Pre-existing motor or sensory neurotoxicity grade 2 according to the WHO criteria (intolerable paresthesia and/or marked motor loss or worse) 5. History of previous chemotherapy 6. Symptomatic brain metastases 7. Known, severe hypersensitivity to temsirolimus or any of the excipients of this product 8. Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ 9. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy 10. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 11. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater or equal than 3 times the ULRR if no demonstrable liver metastases or greater than 5 times the ULRR in the presence of liver metastases 12. Active infection or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial/ receive protocol treatment 13. Pregnancy or breast feeding 14. Concomitant use of Cyp3 A inducers (phenytoin, carbamazepine, rifampicin, barbiturates or St John’s Wort) should be avoided and as should treatment wih strong CyP 3A inhibitors 15. Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment 16. Hypersensitivity to gemcitabine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary endpoints of the trial are: · To explore for potential correlations of tumor molecular profile with clinical outcome in patients treated at the recommended doses. · To estimate the Quality of Life benefits measured by the EuroQoL 5D scale. · To estimate the overall survival of the combination at trial closure. · To evaluate the nature, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of the combination of temsirolimus and gemcitabine. ;Main Objective: The primary objective of this study is: 1. Determine the maximum tolerated dose and recommended phase II dose of temsirolimus and gemcitabine in patients with pancreatic cancer. 2. To estimate the progression free survival in patients treated with the temsirolimus+gemcitabine combination. ;Primary end point(s): Phase I Determine the feasibility and MTD for a combination of temsirolimus and gemcitabine Phase II The primary end-point of the phase II study will be the 6-month Progression-Free-Survival. | — |
Countries
Greece
Outcome results
None listed