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Completed

NCT Number: NCT02565641

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

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.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Buchun, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Prior chemotherapy for pancreatic cancer

Treatment and study plan

Capecitabine

Drug

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 names: Xeloda

Gemcitabine

Drug

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 outcomes

  1. Overall objective response rate

    Time frame: At the end of 6 cycles (24 weeks)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label, Phase II Study of Capecitabine Plus Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Oct 1, 2015
Registry last updated
Nov 2, 2016

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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