Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary
Sponsor
Samsung Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02590055
Collaborator
(none)
29
1
1
47
0.6
Study Details
Study Description
Brief Summary
It's a phase 2, single arm study of gemcitabine an docetaxel combination in patients with carcinoma of unknown primary.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
29 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary
Study Start Date
:
Oct 1, 2015
Anticipated Primary Completion Date
:
Sep 1, 2018
Anticipated Study Completion Date
:
Sep 1, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention arm D1, 8 Gemcitabine 1000mg/m2 IV over 30 minutes D1, 8 Docetaxel 35mg/m2 IV over 1hr |
Drug: gemcitabine/docetaxel combination
|
Outcome Measures
Primary Outcome Measures
- Overall survival [one year after later patients enrolled]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
- 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:
-
- 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...)
- pregnant or feeding women 5. current CNS tumor (except total removal or WBRT/GKS done)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
- Principal Investigator: Su Jin Lee, MD, PhD, department of medicine, Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Su Jin Lee,
MD, PhD,
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02590055
Other Study ID Numbers:
- 2015-03-083
First Posted:
Oct 28, 2015
Last Update Posted:
Oct 28, 2015
Last Verified:
Oct 1, 2015