Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary
Phase 2
- Conditions
- Carcinoma of Unknown Primary
- Interventions
- Drug: gemcitabine/docetaxel combination
- Registration Number
- NCT02590055
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
It's a phase 2, single arm study of gemcitabine an docetaxel combination in patients with carcinoma of unknown primary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
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- 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
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Exclusion Criteria
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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)
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention arm gemcitabine/docetaxel combination D1, 8 Gemcitabine 1000mg/m2 IV over 30 minutes D1, 8 Docetaxel 35mg/m2 IV over 1hr
- Primary Outcome Measures
Name Time Method Overall survival one year after later patients enrolled
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of