Colorectal CancerPhase 2NCT00215982
Study of Capecitabine With Irinotecan and Oxaliplatin (Eloxatin) in Advanced Colorectal Cancer
A Phase 2 study testing capecitabine, Oxaliplatin and Irinotecan in people with Colorectal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 countries.
Trial summary
The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. 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, Oxaliplatin and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2004to 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
- Patients must have histological or cytological confirmed metastatic colorectal cancer.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- No prior chemotherapy in the metastatic setting (prior fluorouracil chemotherapy, if administered in the adjuvant setting, and if more than 6 months has passed since the completion of therapy, is allowable). Prior adjuvant radiation therapy allowable provided no greater than 30% total bone marrow included in the field (must be more than 6 weeks since completion of radiation therapy.
- Subject must be 18 years or older
- Life expectancy greater than 12 weeks.
- ECOG performance status <2 (Karnofsky >60%).
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- Patients must have normal organ and marrow function as defined as: leukocytes >3,000/mcL; absolute neutrophil count >1,500/mcL; Platelets >100,000/mcL; total bilirubin within normal institutional limits; AST(SGOT)/ALT (SGPT) <2.5 X institutional upper limit of normal; Creatinine within normal institutional limits and Creatinine clearance (estimated by Cockcroft-Gault equation)>50-mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential).
- Woman of childbearing potential with either a positive or no pregnancy test at baseline. (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
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Prior therapy for MCRC in the metastatic setting.
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Grade 2 or greater peripheral neuropathy.
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 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.
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- Pregnant and nursing women are excluded from this study. Women / men of childbearing potential not using a reliable and appropriate contraceptive method.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Oxaliplatin and Irinotecan or other agents administered during the study.
- 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.
- History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
- History of persistent neurosensory disorder including but not limited to peripheral neuropathy
- 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.
- Any prior platinum based therapy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: A Phase II Study of Capecitabine in Combination With Irinotecan and Oxaliplatin (Eloxatin) in Adult Patients With Advanced Colorectal Cancer
The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
Read the detailed description
The primary objective of the study is to determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan. Secondary objectives are to determine the time to tumor progression and the toxicity and tolerability of Oxaliplatin, Capecitabine and Irinotecan when administered in combination. Study schema is as follows. Cycles are 42 days long. Patients will receive Oxaliplatin and Capecitabine on day 1. Capecitabine is an oral pill that will be taken for 14 days. Patients return again on day 21 when they receive Irinotecan and Capecitabine. Capecitabine again is taken for 14 days. CT scans are performed at the end of the 6 week cycle to determine response.
- Conditions
- Colorectal Cancer
- Being tested
- capecitabine, Oxaliplatin, Irinotecan
- Keywords
- advanced, colon, rectal
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
Also called XELODA™
Capecitabine will be administered at a dose of 825 mg/m2 PO BID, for a total daily dose of 1650 mg/m2. Capecitabine will be administered on days 1-14 followed by 7 day treatment free rest period and days 21-35 followed by a 7 day treatment-free rest period, every six weeks (42 days) of treatment is considered one cycle.
OxaliplatinDrug
Also called E LOXATIN™
Oxaliplatin will be administered at a dose of 130 mg/m2 IV over 120 minutes in 250-500 ML D5W on day 1, every 42 days.
IrinotecanDrug
Also called CAMPTOSAR™
Irinotecan will be administered at a dose of 180mg/m2 IV over 90 minutes on day 21 every 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy | Experimental | Capecitabine in Combination with Irinotecan and Oxaliplatin Receives: Drug: capecitabine; Drug: Oxaliplatin; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
To determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan
Measured: average of 12 months
Secondary outcomes (2)
time to tumor progression
To determine the time to tumor progression in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan
Measured: average of 12 months
toxicity and tolerability
To determine the toxicity and tolerability of Oxaliplatin, Capecitabine and Irinotecan when administered in combination
Measured: average of 12 months
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
- Primary completionJul 2007
- Study completionJul 2007
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.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Christopher Garrett, MD, Principal investigator, H. Lee Moffitt Cancer Center & Research Institute (now at M.D. Anderson)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215982
- Sponsor's protocol ID
- MCC-13424
- Other IDs
- XEL351
- Status last verified
- Sep 2010
- First submitted
- 19 Sep 2005
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Capecitabine in Combination With Irinotecan and Oxaliplatin (Eloxatin) in Adult Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00215982
- Acronym / sponsor ID
- MCC-13424
- Conditions
- Colorectal Cancer
- Keywords
- advanced, colon, rectal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Dec 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 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.
The purpose of this study is to find out how effective the new combination of the drugs Capecitabine (Xeloda), Oxaliplatin (Eloxatin), and Irinotecan (Camptosar) are against colon and rectal cancer. All three of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of colon or rectal cancer. This however is the first time that these three drugs have been combined in this schedule for the treatment of colon/rectal cancer.
Detailed description
The primary objective of the study is to determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan. Secondary objectives are to determine the time to tumor progression and the toxicity and tolerability of Oxaliplatin, Capecitabine and Irinotecan when administered in combination. Study schema is as follows. Cycles are 42 days long. Patients will receive Oxaliplatin and Capecitabine on day 1. Capecitabine is an oral pill that will be taken for 14 days. Patients return again on day 21 when they receive Irinotecan and Capecitabine. Capecitabine again is taken for 14 days. CT scans are performed at the end of the 6 week cycle to determine response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy | Experimental | Drug: capecitabine, Drug: Oxaliplatin, Drug: IrinotecanCapecitabine in Combination with Irinotecan and Oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have histological or cytological confirmed metastatic colorectal cancer.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- No prior chemotherapy in the metastatic setting (prior fluorouracil chemotherapy, if administered in the adjuvant setting, and if more than 6 months has passed since the completion of therapy, is allowable). Prior adjuvant radiation therapy allowable provided no greater than 30% total bone marrow included in the field (must be more than 6 weeks since completion of radiation therapy.
- Subject must be 18 years or older
- Life expectancy greater than 12 weeks.
Key exclusion criteria (15 listed)
- Prior therapy for MCRC in the metastatic setting.
- Patients may not be receiving any other investigational agents.
- Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Grade 2 or greater peripheral neuropathy.
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil.
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 |
|---|---|---|
| capecitabineAlso: XELODA™Capecitabine will be administered at a dose of 825 mg/m2 PO BID, for a total daily dose of 1650 mg/m2. Capecitabine will be administered on days 1-14 followed by 7 day treatment free rest period and days 21-35 followed by a 7 day treatment-free rest period, every six weeks (42 days) of treatment is considered one cycle. | Drug | Combination Therapy |
| OxaliplatinAlso: E LOXATIN™Oxaliplatin will be administered at a dose of 130 mg/m2 IV over 120 minutes in 250-500 ML D5W on day 1, every 42 days. | Drug | Combination Therapy |
| IrinotecanAlso: CAMPTOSAR™Irinotecan will be administered at a dose of 180mg/m2 IV over 90 minutes on day 21 every 42 days. | Drug | Combination Therapy |
Primary outcome
response rate
Time frame: average of 12 months
To determine the radiographic response rate in patients with metastatic colorectal cancer treated with Oxaliplatin, Capecitabine and Irinotecan
2 secondary outcomes
time to tumor progression
Time frame: average of 12 months
toxicity and tolerability
Time frame: average of 12 months
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 25 Nov 2013.
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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.
Christopher Garrett, MD principal investigator
H. Lee Moffitt Cancer Center & Research Institute (now at M.D. Anderson)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine, Oxaliplatin and Irinotecan in people with Colorectal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 2 sites in 2 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 10 inclusion and 15 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. 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?
response rate (time frame: average of 12 months). 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 Nov 2013.