Carcinoma of Unknown Primary
Conditions
Brief summary
It's a phase 2, single arm study of gemcitabine an docetaxel combination in patients with carcinoma of unknown primary.
Interventions
DRUGgemcitabine/docetaxel combination
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | one year after later patients enrolled |
Countries
South Korea
Contacts
Primary ContactYoon Jung Ahn
Outcome results
None listed