E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced pancreatic adenocarcinoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10033633 |
E.1.2 | Term | Pancreatic neoplasms malignant (excl islet cell and carcinoid) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluation of toxicity and activity of the combination |
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E.2.2 | Secondary objectives of the trial |
- Response rate - Toxicity - Overall survival - Clinical benefit - Quality of life |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Progression free survival |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |