cancer of unknown primary (CUP)
Conditions
Interventions
Nab-paclitaxel is administered as a 30-minute infusion at a dose of 100mg/m2 on days 1,8,and 15 followed by carboplatin at an AUC of 6 mg.min/ml(per Calvert formula) given on day1, every 21 days. Resp
Sponsors
Osaka International Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with histologically comfirmed metastatic malignant lesion, with no identifiable primary site by physical examination, imaging, and laboratory examination. 2)No indication for radical operation and radiotherapy. 3)Measurable disease according to RECIST(version1.1). 4)No prior chemotherapy for CUP. 5)ECOG scale: 0-1 6)Patient with enough feasibility for planned chemotherapy(hematological, liver, renal, cardiopulmonary function). 7)peripheral neuropathy <= Grade1 8)Patients who are expected to survive for more than 3 months. 9)Written informed consent.
Exclusion criteria
Exclusion criteria: 1)Pregnancy or breast feeding. 2)Patients unable to take nab-paclitaxel and CBDCA because of significant cardiovascular abnormalities, renal dysfunctions, hepatic insufficiency, uncontrolled diabetes, uncontrolled hypertension, bleeding tendency, active interstitial pneumonia,etc. 3)Known HIV, active hepatitis B, active hepatitis C, and/or other known severe infections, including but not limited tuberculosis. 4)Ascites, pleural effusion, pericardial effusion, which require regular drainage. 5)Any other active malignancy unless free of disease for at least five years. 6)Known active brain metastasis. 7)Known hypersensitivity to any of platinum drugs, paclitaxel, and albumin containing drugs. 8)Specific clinicopathologic subgroups which have effective management. a)Woman with isolated axillary lymph node metastasis. b)Patients with CUP presenting as metastatic cervical or isolated inguinal lymphadenopathy(squamous cell carcinoma). c)Men with features of the extra gonadal germ cell cancer syndrome. d)Men with features of prostate cancer(adenocarcinoma, elevated level of PSA, and osteoblastic bone metastasis). e)Neuroendcrine tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival, overall survival, adverse event | — |
Countries
Japan
Contacts
Public ContactToshinari Yagi
Osaka International Cancer Institute Department of Clinical Oncology
Outcome results
None listed