Colorectal CancerPhase 4NCT00216424
Capecitabine (Xeloda) and Radiation for Patients With Rectosigmoid Carcinoma
A Phase 4 study testing Capecitabine (Xeloda) in people with Colorectal Cancer, run by James A. Haley Veterans Administration Hospital at 1 site in United States.
Trial summary
This study is designed primarily to establish efficacy and estimate resource utilization. The short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week) during the course of radiation therapy is efficacious in locally advanced, non-metastatic rectosigmoid carcinoma and will improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Capecitabine (Xeloda)
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jan 2007
- Phase
- Phase 4
- 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 locally advanced nonmetastatic T3-4 N0-3 M0 carcinomas of the rectosigmoid.
- Surgical exploration without resection is permissible.
- Protocol Specific Laboratory Values as defined in section 4.2
- 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 section 7.8 and have precautions been taken as recommended for each drug? Includes Allopurinol, Cimetidine, Sorivudine and Brivudine, Anticoagulants, Phenytoin, and Laxatives.
Who cannot join
- Patients who fulfill any of the following criteria will be excluded:
- 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).
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or 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.
Show all 24Show fewer
- 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 unstable 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 metastases 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 (e.g., delayed wound healing).
- 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 <30ml/min as calculated with Cockroft-Gault equation.
- Note: In patients with moderate renal impairment (estimated creatinine clearance 30-50 mL/min) at baseline, a dose reduction to 75% of the capecitabine starting dose is recommended.
- Serum bilirubin > 1.5 x upper normal limit.
- ALT (SGOT), AST (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 or > 10 x upper normal limit in the case of bone disease)
- Unwillingness to give written informed consent or HIPAA privacy authorization.
- Unwillingness to participate or inability to comply with the protocol requirements 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: An Open Label, Phase II Study of Capecitabine (Xeloda) Plus Conformal Radiotherapy for Patients With Locally Advanced, Non-Metastatic Rectosigmoid Carcinoma
This study is designed primarily to establish efficacy and estimate resource utilization. The short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week) during the course of radiation therapy is efficacious in locally advanced, non-metastatic rectosigmoid carcinoma and will improve resectability. The long-term working hypothesis is that if 3-D CRT is combined with the potentiating and additive effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. In addition, it is expected that the simplicity of using an oral agent (capecitabine) will be associated with reduced cost and resource utilization.
Read the detailed description
Patients will all receive the combined treatment of 3-D external radiation therapy plus Xeloda®. External Radiation Therapy to the pelvis, lower abdomen and rectal area will be given once a day, five days a week, Monday through Friday, for about five to six weeks using three dimensional techniques.
Xeloda® (oral chemotherapy) is a pill taken by mouth. This medication will be taken during the course of radiation therapy on days that radiation treatments are given. Xeloda pills will be taken twice daily beginning with the first day of radiation therapy treatments and ending on the last day of radiation therapy treatment.
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, sometimes including a digital rectal exam
- blood tests including a (blood) pregnancy test will be done before starting treatment if the patient is a woman able to have children.
- urinalysis
- ECG (heart tracing)
- chest X-ray
- ultrasound, which produces pictures of the rectal area using sound waves· CT scan of the pelvis and abdomen
Some people may need surgery, others may require more chemotherapy, and others may require no additional treatment depending on how their tumor responded to the Xeloda® and radiation therapy treatments.
Patients will also be asked to complete two questionnaires about their fatigue, general quality of life, and bowel functioning.
- Conditions
- Colorectal Cancer
- Being tested
- Capecitabine (Xeloda)
- Keywords
- Colon cancer, Rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal 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.
Tumor response and resectability of tumor following treatment with radiation and capecitabine (Xeloda).
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 startFeb 2005
- Study completionJan 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 Colorectal 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT00216424
- Sponsor's protocol ID
- XEL372
- Status last verified
- Nov 2007
- First submitted
- 21 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
- An Open Label, Phase II Study of Capecitabine (Xeloda) Plus Conformal Radiotherapy for Patients With Locally Advanced, Non-Metastatic Rectosigmoid Carcinoma
- ClinicalTrials.gov ID
- NCT00216424
- Acronym / sponsor ID
- XEL372
- Conditions
- Colorectal Cancer
- Keywords
- Colon cancer, Rectal cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of accrual
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- James A. Haley Veterans Administration HospitalUS federal agency
- Collaborators
- Hoffmann-La Roche
- Study start
- Feb 2005
- Study completion
- Jan 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.
This study is designed primarily to establish efficacy and estimate resource utilization. The short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week) during the course of radiation therapy is efficacious in locally advanced, non-metastatic rectosigmoid carcinoma and will improve resectability. The long-term working hypothesis is that if 3-D CRT is combined with the potentiating and additive effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. In addition, it is expected that the simplicity of using an oral agent (capecitabine) will be associated with reduced cost and resource utilization.
Detailed description
Patients will all receive the combined treatment of 3-D external radiation therapy plus Xeloda®. External Radiation Therapy to the pelvis, lower abdomen and rectal area will be given once a day, five days a week, Monday through Friday, for about five to six weeks using three dimensional techniques.
Xeloda® (oral chemotherapy) is a pill taken by mouth. This medication will be taken during the course of radiation therapy on days that radiation treatments are given. Xeloda pills will be taken twice daily beginning with the first day of radiation therapy treatments and ending on the last day of radiation therapy treatment.
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, sometimes including a digital rectal exam
- blood tests including a (blood) pregnancy test will be done before starting treatment if the patient is a woman able to have children.
- urinalysis
- ECG (heart tracing)
- chest X-ray
- ultrasound, which produces pictures of the rectal area using sound waves· CT scan of the pelvis and abdomen
Some people may need surgery, others may require more chemotherapy, and others may require no additional treatment depending on how their tumor responded to the Xeloda® and radiation therapy treatments.
Patients will also be asked to complete two questionnaires about their fatigue, general quality of life, and bowel functioning.
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 locally advanced nonmetastatic T3-4 N0-3 M0 carcinomas of the rectosigmoid.
- Surgical exploration without resection is permissible.
Key exclusion criteria (24 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).
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or 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.
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
Tumor response and resectability of tumor following treatment with radiation and capecitabine (Xeloda).
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.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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 4 study testing Capecitabine (Xeloda) in people with Colorectal Cancer, 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 24 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Tumor response and resectability of tumor following treatment with radiation and capecitabine (Xeloda).. 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.