Condition or disease | Intervention/treatment | Phase |
---|---|---|
Carcinoma of Unknown Primary | Drug: gemcitabine/docetaxel combination | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | October 2015 |
Estimated Primary Completion Date : | September 2018 |
Estimated Study Completion Date : | September 2019 |
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 |
Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1. favorable group CUP
Contact: Yoon Jung Ahn | younjeong.ahn@samsung.com |
Korea, Republic of | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of, 135-710 | |
Contact: Yoon Jung Ahn younjeong.ahn@samsung.com | |
Principal Investigator: Su Jin Lee, MD, PhD |
Principal Investigator: | Su Jin Lee, MD, PhD | department of medicine, Samsung Medical Center |
Tracking Information | ||||
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First Submitted Date ICMJE | October 27, 2015 | |||
First Posted Date ICMJE | October 28, 2015 | |||
Last Update Posted Date | October 28, 2015 | |||
Study Start Date ICMJE | October 2015 | |||
Estimated Primary Completion Date | September 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall survival [ Time Frame: one year after later patients enrolled ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary | |||
Official Title ICMJE | Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Carcinoma of Unknown Primary | |||
Intervention ICMJE | Drug: gemcitabine/docetaxel combination | |||
Study Arms ICMJE | Experimental: Intervention arm
D1, 8 Gemcitabine 1000mg/m2 IV over 30 minutes D1, 8 Docetaxel 35mg/m2 IV over 1hr
Intervention: Drug: gemcitabine/docetaxel combination
|
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
29 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | September 2019 | |||
Estimated Primary Completion Date | September 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
|||
Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02590055 | |||
Other Study ID Numbers ICMJE | 2015-03-083 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Su Jin Lee, Samsung Medical Center | |||
Study Sponsor ICMJE | Samsung Medical Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Samsung Medical Center | |||
Verification Date | October 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |