NCT00316420

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 pancreatic-cancer

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 8, 2010

Status Verified

March 1, 2010

Enrollment Period

5.2 years

First QC Date

April 18, 2006

Last Update Submit

March 4, 2010

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • MTD and DLT for the combination therapy of gemcitabine and capecitabine

    January 2010

Secondary Outcomes (1)

  • Tumor Response

    January 2010

Interventions

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

Also known as: Xeloda
GemcitabineDRUG

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

Also known as: Gemzar

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Medical Center Cancer Institute

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

CapecitabineGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Philip Gold, MD

    Swedish Medical Center Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Henry Kaplan, MD

    Swedish Medical Center Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

December 1, 2003

Primary Completion

February 1, 2009

Study Completion

August 1, 2009

Last Updated

March 8, 2010

Record last verified: 2010-03

Locations

US(1)