Cancers of Unknown Primary (CUP) MedDRA version: 20.0 Level: PT Classification code 10073059 Term: Malignant neoplasm of unknown primary site System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ABRAXANE - 5 MG/ML - POLVERE PER SOSPENSIONE PER INFUSIONE - USO ENDOVENOSO- 100 MG - FLACONCINO(VETRO) 1 FLACONCINO
Product Name: Abraxane
Product Code: [Abraxane]
Pharmaceutical Form: Po
Sponsors
FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Provision of written informed consent. - Patients must be = 18 years of age. - Diagnosis of CUP according to CUP Diagnostic Guidelines derived from ESMO 2011 and NCCN 2015 guidelines. - Sufficient archived biopsy tissue from a surgical or core needle biopsy required to perform the CUP multiplex assay. - Eastern Cooperative Oncology Group performance status = 2. - No previous systemic therapy. - At least one measurable lesion by RECIST Criteria. - Good liver, cardiac, lung and marrow bone function. - Evidence of non-childbearing status for female patients: negative urine or serum pregnancy test within 21 days of study treatment for women of childbearing potential, or postmenopausal status. - Patients of child bearing potential and their partners, who are sexually active, must agree to the use of highly effective forms of contraception throughout their participation in the study. - Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations. 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 88 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: - Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, breast Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma. - Specific treatable CUP syndromes including: extragonadal germ cell syndrome; neuroendocrine carcinoma; adenocarcinoma isolated to axillary lymph nodes (women cancer); peritoneal carcinomatosis (women - ovarian cancer); squamous carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes; single resectable metastasis. - Patients receiving any radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study entry. - Patients with symptomatic uncontrolled brain metastases. - Major surgery within 2 weeks of starting the study and patients must have recovered from any effects of any major surgery. - Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. - Pregnant or breast feeding women. - Immunocompromised patients, eg, patients who are known to be serologically positive for human immunodeficiency virus (HIV). - Patients with known hepatic disease (eg, Hepatitis B or C). - Previous cancer treatment. - Patients currently enrolled in another clinical trial, except AGNOSTOS PROFILING. - Patients that are receiving chemotherapy, hormonal therapy (HRT is acceptable) or other novel agents. - Patients receiving live virus and bacterial vaccines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy (as measured by objective tumor response) of nab-paclitaxel in combination with either carboplatin or gemcitabine in treatment-naïve patients with CUP.;Secondary Objective: -To assess the duration of response, time to progression (TTP) and overall survival (OS) of CUP patients after nab-paclitaxel- gemcitabine or nab-paclitaxel- carboplatin; -to evaluate the safety of combining nab-paclitaxel with gemcitabine or carboplatin in CUP patients treatment. ;Primary end point(s): Objective response rate (ORR) as evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines;Timepoint(s) of evaluation of this end point: Every nine weeks with >/ = confirmation of response every 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Efficacy: TTP, OS, and duration of response according to RECIST version 1.1; - Safety: toxicity according to CTCAE version 4.03;Timepoint(s) of evaluation of this end point: Every nine weeks with >/ = confirmation of response every 4 weeks; As required by law in the field of pharmacovigilace in clinical trials | — |
Countries
Italy
Contacts
Public ContactCLINICAL TRIALS COORDINATION UNIT
Fondazione del Piemonte per l'Oncologia
Outcome results
None listed