E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Uptake of Octreoscan in sst-2 receptor positive Gastro Entero Pancreatic neuroendocrine tumors injected in systemical and locoregional way. |
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MedDRA Classification |
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 |
To compare the uptake of hepatic-artery injected 111In-DTPA-octreotide in livermetastasis versus antecubital injected 111In-DTPA-octreotide in patients with somatostatin receptor positive GEP tumors (including bronchial carcinoids). |
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E.2.2 | Secondary objectives of the trial |
To compare the uptake of hepatic-artery injected 111In-DTPA-octreotide in normal organs(eg. Kidney and spleen) versus antecubital injected 111In- DTPA-octreotide in patients with somatostatin receptor positive GEP tumors (including bronchial carcinoids).
To evaluate the safety of hepatic artery injection of radioactive analogues. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Presence of histology proven GEP tumor(s), including bronchial carcinoids. > 75% of total tumorload intrahepatic. Life expectancy greater than 12 weeks 7 Serum creatinine £150 μmol/liter or 1.7 mg/dL, and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gammacamera based) of ³50 mL/min. Hemoglobin (Hgb) concentration ³5.5 mmol/L (³8.9 g/dL); WBC ³ 2*109/L (2000/mm3); platelets ³ 100*109/L (100*103/mm3). Total bilirubin £3 x ULN. Serum albumin > 30 g/L, or serum albumin £ 30 g/L but normal prothrombin time. Karnofsky Performance Status ³ 60. Presence of at least 1 measurable site of disease. No abberant hepatic artery visible on CT scan. Patient’s written voluntary informed consent to participate in the study, obtained prior to enrollment into the study. The informed consent must be maintained in the investigator's study files. |
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E.4 | Principal exclusion criteria |
Radiotherapy, chemotherapy, or other investigational therapy within 3 months of the start of therapy. Patients with known brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start. Uncontrolled congestive heart failure. Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics). Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least 3 months prior to the first cycle in this study and the disease status during these 3 months has been documented by SWOG criteria as described in this study. Any subject receiving therapy with short-acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radiolabelled somatostatin analogues, or any subject receiving therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radiolabelled somatostatin analogues, unless the uptake on the Octreoscan during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging. In patients with unusual hematological parameters, including an increased MCV (>105 fL), and especially in those who had previous chemotherapy, 8 the advice of a hematologist should be seeked, for adequate further workup. Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study. Pregnancy. Prior radiation therapy to more than 25% of the bone marrow. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Uptake of 111In-DTPA-octreotide in intrahepatic tumor metastasis after hepatic arterial injection and systemic venous injection |
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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 | No |
E.6.4 | Safety | No |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
the patient is his own control (twice scanned) |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |