ACTRN12611000643976
Terminated
Phase 1
Patients with inoperable or metastatic pancreatic cancer treated with gemcitabine and temsirolimus combination to determine safety and efficacy of the combination.
Hellenic Cooperative Oncology Group0 sites85 target enrollmentJune 23, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with inoperable or metastatic pancreatic cancer
- Sponsor
- Hellenic Cooperative Oncology Group
- Enrollment
- 85
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 Response Evaluation Criteria in Solid Tumors (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\.White Blood Count \>4000/microliter (mcl), platelets \> 100,000/mcl and a hemoglobin level \> 9\.5 grams per deciliter (g/dl). Adequate baseline hepatic function, defined as a total bilirubin level \< 2 miligrams per deciliter (mg/dl), serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (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 milliliter per minute (ml/min).
- •10Provision of adequate paraffin\-embedded tumor tissue for translational studies and 10 milliliter (ml) peripheral blood for Deoxyribonucleic acid (DNA) study.
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 World Health Organization (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 Common Terminology Criteria (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)
Outcomes
Primary Outcomes
Not specified
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