Carcinoma, HepatocellularPhase 2NCT00635323
Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma
A Phase 2 study testing Irinotecan plus capecitabine in people with Carcinoma, Hepatocellular, run by Pfizer at 9 sites in 4 countries.
Trial summary
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Irinotecan plus capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Nov 2002to May 2005
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma
- Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement)
- Eastern Cooperative Oncology Group performance status of ?2
Who cannot join
- Decompensated cirrhosis or stage C (Index>10) according to the Child-Pugh Classification
- Current history of chronic diarrhoea
- Reproductive potential not using adequate contraceptive measures
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
South Korea4 sites
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 136-705
Pfizer Investigational Site
Seoul, 138-736
Pfizer Investigational Site
Seoul, 152-703
Taiwan3 sites
Pfizer Investigational Site
Keelung, 204
Pfizer Investigational Site
Taipei, 112
Pfizer Investigational Site
Taipei
About this study
Official title: A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable Hepatocellular Carcinoma
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Irinotecan plus capecitabine
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan plus capecitabineDrug
Irinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Irinotecan plus capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: Week 6
Secondary outcomes (7)
Time to progression
Measured: Weeks 6, 12, 18, 24, 36, and 1 year
Duration of overall response
Measured: Weeks 6, 12, 18, 24, 36, and 1 year
Overall tumour growth control rate
Measured: Weeks 6, 12, 18, 24, 36, and 1 year
Overall survival
Measured: Weeks 6, 12, 18, 24, 36, and 1 year
Adverse events
Measured: Weeks 6, 12, 18, 24, 36, and 1 year
Physical exam
Measured: Weeks 6, 12, 18, 24, 36, and 1 year
Laboratory tests
Measured: Weeks 6, 12, 18, 24, 36, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startNov 2002
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635323
- Sponsor's protocol ID
- XRP4174/2501
- Other IDs
- A5961080
- Status last verified
- Apr 2008
- First submitted
- 5 Mar 2008
- Last updated
- 7 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00635323
- Acronym / sponsor ID
- XRP4174/2501
- Conditions
- Carcinoma, Hepatocellular
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- May 2005 (actual)
- First posted
- 13 Mar 2008 (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.
To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Irinotecan plus capecitabine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma
- Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement)
- Eastern Cooperative Oncology Group performance status of ?2
Key exclusion criteria (3 listed)
- Decompensated cirrhosis or stage C (Index>10) according to the Child-Pugh Classification
- Current history of chronic diarrhoea
- Reproductive potential not using adequate contraceptive measures
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 |
|---|---|---|
| Irinotecan plus capecitabineIrinotecan 200-250 mg/m2 intravenous infusion over 30 to 90 minutes on day 1 of a 3-week cycle. Capecitabine 1000 mg/m2 oral tablet twice daily for 14 days followed by a 7 day rest throughout the treatment period for | Drug | A |
Primary outcome
Overall response rate
Time frame: Week 6
7 secondary outcomes
Time to progression
Time frame: Weeks 6, 12, 18, 24, 36, and 1 year
Duration of overall response
Time frame: Weeks 6, 12, 18, 24, 36, and 1 year
Overall tumour growth control rate
Time frame: Weeks 6, 12, 18, 24, 36, and 1 year
Overall survival
Time frame: Weeks 6, 12, 18, 24, 36, and 1 year
Adverse events
Time frame: Weeks 6, 12, 18, 24, 36, and 1 year
Physical exam
Time frame: Weeks 6, 12, 18, 24, 36, and 1 year
Laboratory tests
Time frame: Weeks 6, 12, 18, 24, 36, and 1 year
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 7 Apr 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan plus capecitabine in people with Carcinoma, Hepatocellular, run by Pfizer at 9 sites in 4 countries.
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 3 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 7 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea, Taiwan, China, Hong Kong. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Overall response rate (time frame: Week 6). 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 7 Apr 2008.