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Completed

NCT Number: NCT00316420

Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer

The purpose of this study is to test the effectiveness and safety of the drug combination of gemcitabine and capecitabine (Xeloda) in patients with advanced pancreatic cancer.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Swedish Medical Center Cancer Institute

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Metastatic or unresectable pancreatic cancer
  • No prior chemotherapy except radiation-sensitizing doses of 5-FU
  • No radiotherapy less than 4 weeks prior to the start of the study

Exclusion criteria

  • Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
  • Moderate to severe renal impairment
  • Uncontrolled diabetes
  • Inability to swallow tablets

Treatment and study plan

Capecitabine (Xeloda)

Drug

650 mg/m2 po bid Days 1-14 750 mg/m2 po bid Days 1-14 850 mg/m2 po bid Days 1-14 950 mg/m2 po bid Days 1-14

Other names: Xeloda

Gemcitabine

Drug

750 mg/m2 IV Days 1 & 8 q 21 days

Other names: Gemzar

Primary outcomes

  1. MTD and DLT for the combination therapy of gemcitabine and capecitabine

    Time frame: January 2010

Secondary outcomes

  1. Tumor Response

    Time frame: January 2010

Sponsors and collaborators

Lead sponsor

Swedish Medical Center

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Apr 20, 2006
Registry last updated
Mar 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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