Cancer of LiverPhase 1NCT00216437
Dose Escalation Study Combining Oral Capecitabine (Xeloda) and Radiotherapy for Patients With Unresectable Liver or Cholangiocarcinoma
A Phase 1 study testing Capecitabine (Xeloda) in people with Cancer of Liver, run by James A. Haley Veterans Administration Hospital at 1 site in United States.
Trial summary
Our long-term working hypothesis is that if 3-D radiation is combined with the effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Liver
- What is being tested?
- Capecitabine (Xeloda)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Mar 2007
- 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
- Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- Age >18 years
- Ambulatory outpatients (if applicable), with Karnofsky performance status of >60
- Histologically or cytologically confirmed unresectable hepatocellular carcinoma, liver mets with no evidence of extrahepatic disease, or cholangiocarcinoma. (see exclusion criteria 10)
- At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques.
- Protocol Specific Laboratory Values as described below in section 6.9 number15.
- Has a negative serum pregnancy test within 7 days prior to start of therapy (female patients of childbearing potential).
- Have concomitant medications been reviewed with patient to address contraindicated medications described in protocol section 6.2.8 and have precautions been taken as recommended for each drug? Includes Allopurinol, Cimetidine, Sorivudine and Brivudine, Anticoagulants, Phenytoin, and Laxatives.
Who cannot join
- Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman or men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration
- Life expectancy < 3 months.
- Serious, uncontrolled, concurrent infection(s).
- Any prior fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 12 months earlier).
- Prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil or known DPD deficiency.
- Completion of previous chemotherapy regimen < four weeks prior to the start of study treatment, or with related toxicities unresolved prior to the start of study treatment.
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- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Evidence of extrahepatic disease or history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake
- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- Known, existing uncontrolled coagulopathy
- Any of the following laboratory values:
- Abnormal hematologic values (neutrophils < 1.5 x 109/L, platelet count < 100 x 109/L)
- Impaired renal function (estimated creatinine clearance <50ml/min as calculated with Cockroft-Gault equation.
- Serum bilirubin > 2.0 x upper normal limit.
- AST, ALT (SGOT/SGPT) > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases).
- Alkaline phosphatase > 2.5 x upper normal limit (or > 5 x upper normal limit in the case of liver metastases).
- Unwillingness to give written informed consent or provide HIPAA privacy authorization.
- Unwillingness to participate or inability to comply with the protocol for the duration of the study.
- Patient taking a contraindicated medication(s) described in section 6.2.8 (see inclusion criteria #8 for list of agents) and no appropriate substitute agent is available, or patient unable or refuses to take substitute agent.
Trial locations and contacts
1 site in 1 country.
United States1 site
James A. Haley Veterans Administration Hospital
Tampa, Florida, 33612
About this study
Official title: A Phase I Dose Escalation Study to Assess the Maximum Tolerated Dose and Feasibility of Combining Oral Capecitabine (Xeloda) and Conformal Radiotherapy (CRT) for Patients With Unresectable Hepatocellular Carcinoma, Multiple Hepatic Metastases or Cholangiocarcinoma
Our long-term working hypothesis is that if 3-D radiation is combined with the effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. The primary objective is to determine the maximum tolerated dose of capecitabine used along with 3-D conformal radiation therapy.
Capecitabine will be taken by mouth each day of radiation. The total daily dose should be taken as two divided doses approximately 12 hours apart, within 30 minutes after eating, ideally after breakfast and the evening meal. The overall total number of patients expected to participate in this study could be as high as 30 depending on how the treatment is tolerated.
Read more
The first group (3-6 patients) on the study will receive the drug (Xeloda®) at 600mg/m² (level 1) and radiation. If the first group does well, the second group of patients on the study (3-6 patients) will receive 825 mg/m² (level 2) and radiation. If the second group does well, the third group will receive 1,000 mg/m² (level 3) and radiation. If the first dose level of 600mg/m² is NOT tolerated, we will reduce the dose to 500mg/m² and enroll another 3-6 patients at the lower dose.
After the highest tolerated dose is identified, 12 additional patients will be treated at that dose to further test the safety of the treatment and better understand the effects of the treatment on disease with more patients.
The following tests and procedures are part of regular medical treatment (standard care) for the disease and are also required for this study.
- physical examinations
- blood tests including pregnancy test
- urinalysis
- ECG (heart tracing)
- chest X-ray
- CT scan of the abdomen
Follow-up visits are done 1 month after radiation, then 3 months later, then every 3 months for 2 years.
- Conditions
- Cancer of Liver
- Being tested
- Capecitabine (Xeloda)
- Keywords
- Liver cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xeloda)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startDec 2004
- Study completionMar 2007
Why it stopped: lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of LiverStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James A. Haley Veterans Administration Hospital
- Sponsor type
- US federal agency
- Collaborators
- Hoffmann-La Roche
- Investigators
- Ismail Kazem, MD, Principal investigator, James A. Haley Veterans Administration Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216437
- Sponsor's protocol ID
- XEL346
- Status last verified
- Nov 2007
- First submitted
- 20 Sep 2005
- Last updated
- 12 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study to Assess the Maximum Tolerated Dose and Feasibility of Combining Oral Capecitabine (Xeloda) and Conformal Radiotherapy (CRT) for Patients With Unresectable Hepatocellular Carcinoma, Multiple Hepatic Metastases or Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT00216437
- Acronym / sponsor ID
- XEL346
- Conditions
- Cancer of Liver
- Keywords
- Liver cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of accrual
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- James A. Haley Veterans Administration HospitalUS federal agency
- Collaborators
- Hoffmann-La Roche
- Study start
- Dec 2004
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Sep 2005 (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.
Our long-term working hypothesis is that if 3-D radiation is combined with the effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. The primary objective is to determine the maximum tolerated dose of capecitabine used along with 3-D conformal radiation therapy.
Capecitabine will be taken by mouth each day of radiation. The total daily dose should be taken as two divided doses approximately 12 hours apart, within 30 minutes after eating, ideally after breakfast and the evening meal. The overall total number of patients expected to participate in this study could be as high as 30 depending on how the treatment is tolerated.
The first group (3-6 patients) on the study will receive the drug (Xeloda®) at 600mg/m² (level 1) and radiation. If the first group does well, the second group of patients on the study (3-6 patients) will receive 825 mg/m² (level 2) and radiation. If the second group does well, the third group will receive 1,000 mg/m² (level 3) and radiation. If the first dose level of 600mg/m² is NOT tolerated, we will reduce the dose to 500mg/m² and enroll another 3-6 patients at the lower dose.
After the highest tolerated dose is identified, 12 additional patients will be treated at that dose to further test the safety of the treatment and better understand the effects of the treatment on disease with more patients.
The following tests and procedures are part of regular medical treatment (standard care) for the disease and are also required for this study.
- physical examinations
- blood tests including pregnancy test
- urinalysis
- ECG (heart tracing)
- chest X-ray
- CT scan of the abdomen
Follow-up visits are done 1 month after radiation, then 3 months later, then every 3 months for 2 years.
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 (8 listed)
- Provide written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- Age >18 years
- Ambulatory outpatients (if applicable), with Karnofsky performance status of >60
- Histologically or cytologically confirmed unresectable hepatocellular carcinoma, liver mets with no evidence of extrahepatic disease, or cholangiocarcinoma. (see exclusion criteria 10)
- At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Ascites, pleural effusion, and bone metastases are not considered measurable. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques.
Key exclusion criteria (23 listed)
- Pregnant or lactating woman. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman or men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration
- Life expectancy < 3 months.
- Serious, uncontrolled, concurrent infection(s).
- Any prior fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 12 months earlier).
- Prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil or known DPD deficiency.
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) | Drug | – |
Primary outcome
Dose-limiting toxicity.
Results and safety
The study was stopped early (reason given: lack of accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2007.
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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.
Ismail Kazem, MD principal investigator
James A. Haley Veterans Administration Hospital
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) in people with Cancer of Liver, run by James A. Haley Veterans Administration Hospital 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 8 inclusion and 23 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: stopped early, as of the sponsor's last update on 12 Nov 2007. 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 was stopped early (reason given: lack of accrual). Results are not available in the source record.
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?
Dose-limiting toxicity.. 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 12 Nov 2007.