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NCT02590055 Clinical Trial

Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary

Carcinoma of Unknown Primary Clinical Trial

Official title:
Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02590055
Other study ID # 2015-03-083
Secondary ID
Status Recruiting
Phase Phase 2
First received October 27, 2015
Last updated October 27, 2015
Start date October 2015
Est. completion date September 2019

Study information
Verified date October 2015
Source Samsung Medical Center
Contact Yoon Jung Ahn
Email younjeong.ahn@samsung.com
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

It's a phase 2, single arm study of gemcitabine an docetaxel combination in patients with carcinoma of unknown primary.

Recruitment information / eligibility
Status Recruiting
Enrollment 29
Est. completion date September 2019
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- 1. age>=20 2. pathologically confirmed patients with carcinoma of unknown primary 3. unfavorable type of CUP 4. ECOG PS 0-2 5. more than 1 evaluable lesion 6. life expectancy > 12 weeks 7. no prior history of chemotherapy 8. more than 2 weeks after surgery or radiotherapy 9. proper organ function 10. written informed consent

Exclusion Criteria:

- 1. favorable group CUP

- squamous cell carcinoma in the cervical or inguinal LN only women with axillary LN metastasis only women with peritoneal carcinomatosis only well-differentiated neuroendocrine tumors poorly-differentiated tumors with midline tumor or elevated human HCG/AFP men with adenocarcinoma and elevated PSA 2. severe, unstable heart disease 3. uncontrolled systemic disease (DM, HTN, hypothyroidism, infection...) 4. pregnant or feeding women 5. current CNS tumor (except total removal or WBRT/GKS done)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gemcitabine/docetaxel combination

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival one year after later patients enrolled No
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