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Trial record 69 of 131 for:    Pancreatic Cancer | ( Map: South Korea )

A Study of Capecitabine (Xeloda) in Participants With Locally Advanced or Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02565641
Recruitment Status : Completed
First Posted : October 1, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy and safety of oral capecitabine plus intravenous (IV) gemcitabine in participants with locally advanced or metastatic pancreatic cancer. The anticipated time on study treatment is 3 to 12 months, and the target sample size is 56 individuals.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Capecitabine Drug: Gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase II Study of Capecitabine Plus Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Study Start Date : March 2003
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006


Arm Intervention/treatment
Experimental: Capecitabine + Gemcitabine
Participants will receive oral capecitabine (830 milligrams per meter-squared [mg/m^2]) twice daily (BID) as intermittent treatment (Days 1 to 21 every 4 weeks [q4w]) along with IV infusion of gemcitabine (1000 mg/m^2) once weekly as intermittent treatment (4-week cycles of 3-week treatment period and 1-week rest period).
Drug: Capecitabine
Capecitabine will be administered orally at 830 mg/m^2 BID (equivalent to a total daily dose of 1660 mg/m^2) as intermittent treatment (given days 1 to 21 q4w).
Other Name: Xeloda

Drug: Gemcitabine
Gemcitabine will be administered at a dose of 1000 mg/m^2 once weekly via IV infusion as intermittent treatment (repeated 4-week cycles of 3 weeks treatment and 1 week rest).




Primary Outcome Measures :
  1. Overall objective response rate [ Time Frame: At the end of 6 cycles (24 weeks) ]

Secondary Outcome Measures :
  1. Duration of response [ Time Frame: Up to approximately 3.5 years ]
  2. Time to disease progression [ Time Frame: Up to approximately 3.5 years ]
  3. Time to response [ Time Frame: Up to approximately 3.5 years ]
  4. Time to treatment failure [ Time Frame: Up to approximately 3.5 years ]
  5. Overall survival [ Time Frame: Up to approximately 3.5 years ]
  6. Incidence of adverse events [ Time Frame: Up to approximately 3.5 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult participants 18 to 75 years of age
  • Locally advanced or metastatic pancreatic cancer

Exclusion Criteria:

- Prior chemotherapy for pancreatic cancer


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565641


Locations
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Korea, Republic of
Buchun, Korea, Republic of, 420-021
Daegu, Korea, Republic of
Seoul, Korea, Republic of, 135-720
Seoul, Korea, Republic of, 137-702
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 158-710
Seoul, Korea, Republic of
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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OverallOfficial: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02565641     History of Changes
Other Study ID Numbers: ML16832
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs