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出境医 / 临床实验 / Phase 2 Study of Gemcitabine and Docetaxel Combination Chemotherapy in Patients With Carcinoma of Unknown Primary

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

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
Carcinoma of Unknown Primary Drug: gemcitabine/docetaxel combination Phase 2

Study Design
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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
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 :
  1. Overall survival [ Time Frame: one year after later patients enrolled ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Contacts
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Contact: Yoon Jung Ahn younjeong.ahn@samsung.com

Locations
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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         
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Su Jin Lee, MD, PhD department of medicine, Samsung Medical Center
Tracking Information
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
 (submitted: October 27, 2015)
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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 27, 2015)
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:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Su Jin Lee, MD, PhD department of medicine, Samsung Medical Center
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