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Status unknownNCT02590055Updated Oct 28, 2015

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

A Phase 2 interventional study of gemcitabine/docetaxel combination in Carcinoma of Unknown Primary, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-10-28.

Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Carcinoma of Unknown Primary
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's planned enrollment of 29 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts 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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (estimated)

Study arms

  • Experimental
    Intervention arm

    D1, 8 Gemcitabine 1000mg/m2 IV over 30 minutes D1, 8 Docetaxel 35mg/m2 IV over 1hr

    Drug: gemcitabine/docetaxel combination

Interventions

  • Druggemcitabine/docetaxel combination
06

What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: one year after later patients enrolled

07

Study locations

1 of 1 sites recruiting
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02590055
Lead sponsor
Samsung Medical Center
Responsible party
Su Jin Lee (MD, PhD, Samsung Medical Center) — Principal investigator
First posted
Oct 28, 2015
Start date
Oct 2015
Primary completion
Sep 2018 (estimated)
Completion
Sep 2019 (estimated)
Last update
Oct 28, 2015

Study contacts

Yoon Jung Ahn
Contact
younjeong.ahn@samsung.com
Su Jin Lee, MD, PhD
principal investigator · department of medicine, Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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