Advanced pancreatic adenocarcinoma MedDRA version: 9.1 Level: HLT Classification code 10033633 Term: Pancreatic neoplasms malignant (excl islet cell and carcinoid)
Conditions
Interventions
Trade Name: GEMZAR INFUS 1FL 1G POLV
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Gemcitabine
CAS Number: 122111-03-9
Concentration unit: g gram(s)
Concentration type: equal
Concentr
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must fulfil all of the following criteria to be eligible for admission to the study Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas cancer which is unresectable, locally advanced or metastatic. Patients must have evidence of disease, but measurable disease is not mandatory. To be considered evaluable for complete or partial response, patients must have at least one measurable lesion as follows X-ray, ultrasound, physical exam 20 mm Conventional CT scan 20 mm Spiral CT scan 10 mm Measurable lesions must be outside a previous radiotherapy field if they are the sole site of disease, unless disease progression has been documented. 18 years of age. Patients may have received prior radiation treatment for management of local disease providing that disease progression has been documented, all toxicities have resolved, and the last fraction of radiation treatment was completed at least 4 weeks prior to randomization. Patients may not have received prior chemotherapy, other than 5FU /- folinic acid or gemcitabine given concurrently with radiation treatment as a radiosensitizer. Investigations including chest x-ray, CT scan of abdomen, CT scan of brain only if clinical suspicion of metastasis and other scans as necessary to document all sites of study disease have been performed within 28 days prior to study registration negative scans performed with 35 days of registration need not be repeated. ECOG performance status 8804;3 Adequate hematological, renal and hepatic functions as defined by the following required laboratory values obtained within 14 days prior to registration Absolute neutrophil count ANC 1.5 x 109/L 1,500 cells/mm3 Platelet count 100x109/L 100,000/mm3 Serum creatinine 1.5 times the upper limit of normal Total bilirubin 2.0 times the upper limit of normal ALT SGPT 2.0 times the upper limit of normal and/or AST SGOT 2.0 times the upper limit of normal Note If clearly attributable to liver metastasis, ALT SGPT and/or AST SGOT values 5 times the upper limit of normal are permitted. Women of childbearing potential WOCBP must have a negative serum or urine pregnancy test All patients must be able and willing to complete the quality of life questionnaires The baseline assessment must already have been completed. Patient has completed Pain Intensity Scale. Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. The patient must sign the consent form prior to registration. Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients entered on this trial will be available for complete documentation of the treatment, toxicity, and follow-up. 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: Patients who fulfil any of the following criteria are not eligible for admission to the study Patients with a history of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with a significant history of cardiac disease, i.e., uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication. Patients with a serious active infection at the time of registration or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment. Patients with a known central nervous system metastases. CT scan of the brain is NOT required unless there is clinical suspicion of CNS metastases. Patients with any condition e.g., psychological, geographical, etc. that does not permit compliance with the protocol. Pregnant or lactating females. Women of child bearing potential or sexually active males who are not employing adequate contraception or practicing complete abstinence . Patients who have had treatment with any investigational drug within 2 weeks prior to inclusion. Patients who have had any major surgery within 2 weeks prior to inclusion. Patients who have ocular inflammation or infection should be fully treated prior to entry to the trial. Any patients requiring ophthalmic surgery during the course of the trial will be withdrawn from the study. Patients who continue to wear contact lenses may have an increased risk of ocular adverse events. The decision to continue to wear contact lenses should be discussed with the patient s treating oncologist and ophthalmologist. Patients with significant opthalmologic abnormalities such as A history of severe dry eye syndrome, Sjogren s syndrome, or keratoconjuctivitis sicca Severe exposure keratopathy Disorders that might increase the risk for epithelium related complications e.g. bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis Congenital abnormality e.g. Fuch s dystrophy Abnormal slit lamp examination using a vital dye e.g. fluorecein, Bengal-Rose Abnormal corneal sensitivity test Schirmer s test or similar tear production test . Patients with GI tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease e.g.. Crohn s, ulcerative colitis , or active peptic ulcer disease. Patients with a history of allergic reactions attributed to compounds with similar chemical or biologic composition to TARCEVA. Prior treatment with inhibitors of EGFR of any kind. Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of toxicity and activity of the combination;Secondary Objective: - Response rate - Toxicity - Overall survival - Clinical benefit - Quality of life;Primary end point(s): - Progression free survival | — |
Countries
Italy
Outcome results
None listed