E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
METASTATIC ADENOCARCINOMA OF UNKNOWN PRIMARY SITE |
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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 |
Determine the efficacy of the combination of gemcitabine and oxaliplatin in terms of objective response rates. |
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E.2.2 | Secondary objectives of the trial |
1. to analyze the toxicity profile. 2. to determine the duration of the response and progression-free survival. 3. to determine the overall survival in these patients.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients with metastatic presentation of cancer in whom, after application of a diagnostic survey comprising detailed anamnesis and physical examination, standard blood analysis and biochemistry testing, serum tumour markers (PSA, aFP and bHCG, in individual cases), chest X ray, TAC of the abdomen and pelvis and mammography (women), it has not been possible to identify the primary tumour 2. Metastatic disease for which no better therapeutic option is available, including the special situations of metastatic presentation of cancer of unknown origin, with specific treatment despite the non-location of the primary tumour 3. Pathology diagnosis of adenocarcinoma. 4. Over 18 years of age. 5. Functional status in ECOG test less than or equal to 2 . 6. At least one measurable lesion in a non-radiated area, conforming to the RECIST criteria. 7. Appropriate haematological, hepatic and renal functions: · Neutrophils ³ 1,500/mm3. · Platelets ³ 100,000/mm3. · Serum creatinine £ 1.5 x upper limit of normality (ULN) · Bilirubin £ 1.5 x ULN · AST and ALT £ 2.5 x ULN in cases of non-hepatic disease or £ 5 x ULN in cases of liver involvement. 8. Life expectancy in excess of 3 months. 9. Informed consent in writing
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E.4 | Principal exclusion criteria |
1. Have received prior chemotherapy treatment. 2. Concomitant use of another antineoplasia treatment, except for palliative radiation therapy, providing that the field to be subjected to radiation does not include the only location used to assess response. 3. Concomitant treatment with experimental drugs. 4. Brain metastases or symptomatic leptomeningeas. 5. Uncontrolled serious infection or medical condition. 6. Pregnancy or breast-feeding. An adequate method of contraception must be used in breast-feeding women or women of childbearing age. 7. Doubts regarding compliance with the treatment plan due to psychological, family or geographical reasons. 8. Active infection or other uncontrolled serious pathology. 9. Previous or current neoplasias in other locations, except for appropriately treated in situ carcinoma of the uterine neck or basal cell carcinoma of the skin. 10. Peripheral neuropathy > grade 1 (CCT-INC scale) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective response rates. |
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
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 | 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) | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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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At least 3 responses must be obtained in the first 13 patients to be assessed. If the desired responses are not documented after the first 13 patients that can be assessed, the response rate will be considered to have been demonstrated as < 20% and the trial will be closed. If the responses intended are obtained, enrolment will continue up to 43 assessable patients so as to ensure the sufficient power of 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 | |