Carcinomas of an unknown primary site (CUP)
Conditions
Interventions
Trade Name: Cisplatino Ferrer Farma 1mg/ml, concentrado para solución para perfusión
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: CISPLATIN
Current Sponsor code: PR1
Concentratio
Sponsors
Institut Català d'Oncologia (ICO)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients presenting with carcinoma of an unknown primary, confirmed by histo-pathological analysis (including an immunohistochemical analysis) and corresponding to one of the following histologic types: moderately or well-differentiated adenocarcinoma, poorly-differentiated adenocarcinoma, undifferentiated carcinoma, squamous-cell carcinoma. 2) Diagnostic work-up in keeping with Standard Options Recommandations des CAPI (Lesimple et al., 2003). 3) Age>18 years. 4) Performance status 0, 1 or 2 according to ECOG. 5) Good or poor prognosis CUP classified according to the GEFCAPI classification. 6) CUP with at least one measurable lesion. 7) Tumour sample available for molecular analysis. 8) CUP not belonging to a subgroup requiring a specific treatment. 9) Satisfactory haematological, renal and hepatic function. 10) Cardiac, respiratory and neurological function compatible with the administration of cisplatin chemotherapy. 11) No previous chemotherapy, for CUP. 12) Previous radiotherapy is acceptable, but it should be completed at least 4 weeks before the start of systemic treatment. Randomisation can be performed during this time frame. 13) All patients with reproductive potential must practice an effective method of birth control throughout the study. Female patients with childbearing potential must have a negative pregnancy test within 7 days before study treatment. 14) Information delivered to patient and informed consent form signed by the patient or legal representative. 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 223 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 223
Exclusion criteria
Exclusion criteria: 1) Patients in whom the diagnosis has not been histologically confirmed (a cytological analysis alone does not permit patient entry onto the trial). 2) Patients with known HIV infection. 3) Patients with symptomatic brain metastases. 4) Associated disease likely to prevent the patient from receiving the treatment. 5) Previous history of cancer (excepted skin basocellular epithelioma or epithelioma in situ of the uterine cervix) during the 5 years before study entry. 6) Patients already included in another clinical trial with an experimental therapy. 7) Pregnant women, and women who are breastfeeding. 8) Compliance with trial medical follow-up impossible due to geographic, social or psychological reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare empiric chemotherapy regimen in patient with CUP (cisplatin-gemcitabine) with standard treatment of the primary suspected by molecular analysis, by means of PFS;Secondary Objective: Response Rate, tolerance, overall survival, pharmacogenomics, translational study.;Primary end point(s): Progression-free survival according to RECIST criteria v1.1.;Timepoint(s) of evaluation of this end point: 5.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Response rate (RECIST criteria) v1.1. 2. Tolerance (NCI-CTC criteria version 4.0). 3. Overall survival. 4. Pharmacogenomics: Genetic polymorphisms in genes involved in cisplatin and gemcitabine metabolism (blood lymphocytes). 5. Translational studies. 6. Medico-economic study (Medical costs and utilities).;Timepoint(s) of evaluation of this end point: 5.5 years | — |
Countries
Spain
Contacts
Public ContactFederico Nepote
MFAR S.L.
Outcome results
None listed