A phase2 study to evaluate the efficacy and safety of weekly nab-paclitaxel in combination with carboplatin in patients with cancer of unknown primary - Efficacy and safety of weekly nab-paclitaxel plus CBDCA in patients with CUP

Yagi Toshinari0 sites17 target enrollmentFebruary 28, 2019

Conditionscancer of unknown primary CUP, nab-Paclitaxel,CBDCA

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: cancer of unknown primary
Sponsor: Yagi Toshinari
Enrollment: 17
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study was discontinued prematurely and the number of enrolled patients was a few. So, it does not lead to a certain conclusion. Judging from enrolled 17 cases, the RR and 50% of PFS were 41.2% and 28.9 weeks, respectively.

Registry

who.int

Start Date

February 28, 2019

End Date

January 10, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Yagi Toshinari

Eligibility 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

•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\)Known hypoadrealism which requires treatment
•9\)Specific clinicopathologic subgroups which have effective management.
•a)Woman with isolated axillary lymph node metastasis.