Phase 2 Study of Gemcitabine and Docetaxel Combination Ch... | NCT02590055

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

NCT02590055

Sponsor

Samsung Medical Center

Status

Unknown status

Last Update Posted

Oct 28, 2015Estimated

Enrollment

29Estimated

Phase

Phase 2

Conditions

Carcinoma of Unknown Primary

Interventions

gemcitabine/docetaxel combination

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Sep 2018Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Oct 27, 2015

First Submission Date that Met QC Criteria

Oct 27, 2015

First Posted Date

Oct 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2015

Last Update Posted Date

Oct 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention arm	Experimental	D1, 8 Gemcitabine 1000mg/m2 IV over 30 minutes D1, 8 Docetaxel 35mg/m2 IV over 1hr	Drug: gemcitabine/docetaxel combination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gemcitabine/docetaxel combination	Drug		Intervention arm

Measure	Description	Time Frame
Overall survival		one year after later patients enrolled

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoon Jung Ahn	Contact			younjeong.ahn@samsung.com

Overall Officials

Name	Affiliation	Role
Su Jin Lee, MD, PhD	department of medicine, Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center	Recruiting	Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D009382	Neoplasms, Unknown Primary

Ancestor Terms

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided