PHASE II TRIAL OF THE COMBINATION OF GEMCITABINE AND OXALIPLATIN IN THE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARCINOMA OF UNKNOWN PRIMARY SITEEstudio fase II de la combinación de gemcitabina y oxaliplatino en el tratamiento de pacientes con adenocarcinoma matastático de origen desconocido.

ACROSS0 个研究点目标入组 43 人开始时间: 2005年10月21日最近更新: 2012年3月19日

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•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

•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)

发起方

ACROSS