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Efficacy and safety of nab-paclitaxel plus carboplatin in patients with Carcinoma of unknown primary site

Efficacy and safety of nab-paclitaxel plus carboplatin in patients with Carcinoma of unknown primary site - Efficacy and safety of CBDCA plus nab-PTX in patients with CUP

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016728
Enrollment
30
Registered
2015-03-06
Start date
2015-01-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carinoma of unknown primary site(CUP)

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 of5 mg.min/ml(per Calvert formula) given on day1, every 21 days. Respo

Sponsors

Teikyo University School of Medicine
Lead Sponsor

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 prior chemotherapy for CUP 3)Patients should be 20 years or older at informed consent. 4)ECOG PS scale: 0-2 5)Patient with enough feasibility for planned chemotherapy(hematological, liver, renal, cardiopulmonary function). 6)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Indication for radical operation and radiotherapy. 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 active brain metastasis. 4)Acute or subacute idiopathic interstitial pneumonia 5)Patient received a bone-marrow transplantation 6)Patient received a peripheral stem cell transplantation 7)Known hypersensitivity to any drugs 8)Seropositivity for HBsAg 9)Pregnancy or breast feeding.

Design outcomes

Primary

MeasureTime frame
1-year survival rate

Secondary

MeasureTime frame
progression free survival, overall survival,response rate,tumor control rate,adverse event,QOL

Countries

Japan

Contacts

Public ContactYasuko Ichikawa

Teikyo University School of Medicine Division of Medical Oncology,Department of Internal Mediine

icchi@med.teikyo-u.ac.jp03-3964-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026