GEMCITABINE COMBINED WITH THE mTOR INHIBITOR TEMSIROLIMUS (CCI-779) IN PATIENTS WITH INOPERABLE OR METASTATIC PANCREATIC CANCER

• Conditions: advanced pancreatic cancer; MedDRA version: 9.1Level: LLTClassification code 10033604Term: Pancreatic cancer

• Registration Number: EUCTR2008-002791-10-GR
• Lead Sponsor: Hellenic Cooperative Oncology Group (HeCOG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-06
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 < 2 mg/dl, SGPT and SGOT < 3 times the upper limits of normal, unless the liver is involved, in which case the transaminase levels could be up to five times the upper limits of normal. Creatinine < 1.5 mg/dl or creatinine clearance > 60 ml/min.
10Provision 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

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

Study & Design

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