Pancreatic CancerPhase 1NCT00316420
Gemcitabine and Capecitabine in Patients With Advanced Pancreatic Cancer
A Phase 1 study testing Capecitabine (Xeloda) and Gemcitabine in people with Pancreatic Cancer, run by Swedish Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Capecitabine (Xeloda) and Gemcitabine
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Aug 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
- Moderate to severe renal impairment
- Uncontrolled diabetes
- Inability to swallow tablets
Trial locations and contacts
1 site in 1 country.
United States1 site
Swedish Medical Center Cancer Institute
Seattle, Washington, 98104
About this study
Official title: Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Capecitabine (Xeloda), Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xeloda)Drug
Also called Xeloda
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
GemcitabineDrug
Also called Gemzar
750 mg/m2 IV Days 1 \& 8 q 21 days
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD and DLT for the combination therapy of gemcitabine and capecitabine
Measured: January 2010
Secondary outcomes (1)
Tumor Response
Measured: January 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startDec 2003
- Primary completionFeb 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Philip Gold, MD, Principal investigator, Swedish Medical Center Cancer InstituteHenry Kaplan, MD, Principal investigator, Swedish Medical Center Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316420
- Sponsor's protocol ID
- TI027 PG/HK
- Status last verified
- Mar 2010
- First submitted
- 18 Apr 2006
- Last updated
- 8 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Gemcitabine and Capecitabine (Xeloda) in Patients With Advanced Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT00316420
- Acronym / sponsor ID
- TI027 PG/HK
- Conditions
- Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Dec 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-FU
- Moderate to severe renal impairment
- Uncontrolled diabetes
- Inability to swallow tablets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine (Xeloda)Also: Xeloda650 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 | Drug | – |
| GemcitabineAlso: Gemzar750 mg/m2 IV Days 1 \& 8 q 21 days | Drug | – |
Primary outcome
MTD and DLT for the combination therapy of gemcitabine and capecitabine
Time frame: January 2010
1 secondary outcome
Tumor Response
Time frame: January 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Gold, MD principal investigator
Swedish Medical Center Cancer Institute
Henry Kaplan, MD principal investigator
Swedish Medical Center Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capecitabine (Xeloda) and Gemcitabine in people with Pancreatic Cancer, run by Swedish Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD and DLT for the combination therapy of gemcitabine and capecitabine (time frame: January 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2010.