METASTATIC ADENOCARCINOMA OF UNKNOWN PRIMARY SITE
Conditions
Interventions
Trade Name: Gemzar
Product Name: Gemcitabina (Gemzar®)
Pharmaceutical Form: Concentrate for solution for infusion
Other descriptive name: Gemcitabina (Gemzar)
Concentration unit: mg/ml milligram(s)/
Sponsors
ACROSS
Eligibility
Sex/Gender
All
Inclusion criteria
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 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: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the efficacy of the combination of gemcitabine and oxaliplatin in terms of objective response rates.;Secondary Objective: 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. ;Primary end point(s): Objective response rates. | — |
Countries
Spain
Outcome results
None listed