Colorectal NeoplasmsPhase 2NCT00506168
Study of Irinotecan & Capecitabine in Metastatic Colorectal Cancer
A Phase 2 study testing Irinotecan, Capecitabine in people with Colorectal Neoplasms and Secondary, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Secondary, Drug Therapy, Combination
- What is being tested?
- Irinotecan, Capecitabine
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2001to Jul 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic colorectal cancer
- ECOG performance status 0-2
- Mesurable lesions
- No prior chemotherapyk or radiotherapy for metastatic disease. Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
- Adjuvnat chemo or radiotherapy was completed at least 6 months prior to start study treatment
- Adequate organ functions
- Expected survival is longer then 6 months
- Informed consent
Who cannot join
- Prior systemic chemotherapy for metastatic disease
- Prior treatment with oxaliplatin or irinotecan
- CNS metastases
- Uncontrolled or severe cardiovascular disease
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
- Other malignancy within the past 3 years except cured non-melanomatous skin cancer or carcinoma in situ of the cervix
Show all 11Show fewer
- Psychiatric disorder or uncontrolled seizure that would preclude compliance
- Pregnant, nursing women or patients with reproductive potential without contraception
- Patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucytosine, phenytoin, or warfarin et al.
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency
- Major surgery within 3 weeks prior to study treatment starts, or lack of complete recovery from the effects of major surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Cancer Center Korea
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer
This study is to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.
Read the detailed description
This is a single center, single arm, open-label, phase II study to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.
Patients younger then 65 will be treated with irinotecan 100 mg/m2 on day 1 and 8 and capecitabine 1,000mg/m2 twice daily from day 1 to 14 every 3 weeks.For patiens equal to or older then 65, doses of irinotecan and capecitabine will be reduced to 60 mg/m2 and 750 mg/2, respectively.
Response assessment will be performed every 3 cycles of chemotherapy.
- Conditions
- Colorectal Neoplasms, Secondary, Drug Therapy, Combination
- Being tested
- Irinotecan, Capecitabine
- Keywords
- Colorectal neoplasms, Secondary, Drug therapy, combination, Irinotecan, Capecitabine
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan, CapecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal response rate and toxicities
Measured: During treatment
Secondary outcomes (1)
Progression-free survival and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startNov 2001
- Study completionJul 2007
Why it stopped: The study drugs are not covered anymore by insurance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Kyung Hae Jung, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506168
- Sponsor's protocol ID
- NCCCTS-01-024
- Status last verified
- Jul 2007
- First submitted
- 23 Jul 2007
- Last updated
- 25 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Irinotecan in Combination With Capecitabine in Previously Untreated Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00506168
- Acronym / sponsor ID
- NCCCTS-01-024
- Conditions
- Colorectal Neoplasms, Secondary, Drug Therapy, Combination
- Keywords
- Colorectal neoplasms, Secondary, Drug therapy, combination, Irinotecan, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study drugs are not covered anymore by insurance.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Nov 2001
- Study completion
- Jul 2007 (actual)
- First posted
- 25 Jul 2007 (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 to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.
Detailed description
This is a single center, single arm, open-label, phase II study to evaluate the efficacy and safety of combination chemotherapy with irinotecan and capecitabine in previously untreated metastatic colorectal cancer.
Patients younger then 65 will be treated with irinotecan 100 mg/m2 on day 1 and 8 and capecitabine 1,000mg/m2 twice daily from day 1 to 14 every 3 weeks.For patiens equal to or older then 65, doses of irinotecan and capecitabine will be reduced to 60 mg/m2 and 750 mg/2, respectively.
Response assessment will be performed every 3 cycles of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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)
- Histologically confirmed metastatic colorectal cancer
- ECOG performance status 0-2
- Mesurable lesions
- No prior chemotherapyk or radiotherapy for metastatic disease. Prior radiotherapy is permitted if it was not administered to target lesions selected for this study and provided it has been completed at least 4 weeks before registration
- Adjuvnat chemo or radiotherapy was completed at least 6 months prior to start study treatment
Key exclusion criteria (11 listed)
- Prior systemic chemotherapy for metastatic disease
- Prior treatment with oxaliplatin or irinotecan
- CNS metastases
- Uncontrolled or severe cardiovascular disease
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
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, Capecitabine | Drug | – |
Primary outcome
Maximal response rate and toxicities
Time frame: During treatment
1 secondary outcome
Progression-free survival and overall survival
Results and safety
The study was stopped early (reason given: The study drugs are not covered anymore by insurance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2007.
Related trials for Colorectal Neoplasms
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.
Kyung Hae Jung, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, Capecitabine in people with Colorectal Neoplasms and Secondary, run by National Cancer Center, Korea at 1 site in South Korea.
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 11 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 25 Jul 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 South Korea. 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 was stopped early (reason given: The study drugs are not covered anymore by insurance.). 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?
Maximal response rate and toxicities (time frame: During treatment). 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 25 Jul 2007.