Colonic DiseasesNCT00250029
Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy Regimen
A study testing Oxaliplatin in people with Colonic Diseases and Cancer, run by New Mexico Cancer Research Alliance at 4 sites in United States.
Trial summary
1.1 To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Diseases, Cancer
- What is being tested?
- Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2004to Mar 2006
- Phase
- Interventional
- 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
- All patients, >18 years of age, with metastatic/recurrent colorectal cancer are eligible.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count > 100,000/mm3 and absence of a regular red blood cell transfusion requirement.
- Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
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- The patient must agree to a biopsy of a sample of tumor for correlative studies.
- The patient is an appropriate candidate for oxaliplatin/capecitabine based chemotherapy.
- The patient must have measurable disease.
Who cannot join
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
- Patients may not have received oxaliplatin previously.
- Patients with a prior unanticipated severe reaction to fluoropyrimidine therapy, or known dihydropyrimidine dehydrogenase (DPD) deficiency, or known hypersensitivity to platinum compounds or any of the components of the study medications.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hematology Oncology Associates
Albuquerque, New Mexico, 87102-3661
Lovelace Sandia Health Systems Dept of Hematology
Albuquerque, New Mexico, 87108
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131
New Mexico Veterans Administration Health Care System
Albuquerque, New Mexico
About this study
Official title: Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy
1.1 To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen.
1.2 To determine a gene expression profile that predicts response to an oxaliplatin based chemotherapy regimen in this cohort of patients.
Read the detailed description
This is a single-arm, non-randomized trial of oxaliplatin and capecitabine. Patients that are placed on other studies that utilize the same chemotherapy regimen can enter this study. Those patients will be treated according to the clinical study on which they have been entered. For patients not on another clinical trial, the treatment outlined below should be followed.
- Conditions
- Colonic Diseases, Cancer
- Being tested
- Oxaliplatin
- Keywords
- Colorectal Cancer, Pilot Study, Oxaliplatin
- Medical subject headings
- Colonic Diseases, Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called XELOX (oxaplatin+capecitabine)
Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2 hour intravenous infusion on day 1 of a three week cycle, prior to the 1st dose of capecitabine. 5-HT3 antagonists with or without dexamethasone premedication are strongly recommended. Oxaliplatin may be infused either through a peripheral vein or a central venous line. The infusion lines must be adequately flushed with 5% dextrose solution (D5W) between oxaliplatin infusion \& the administration of any other drug.
Capecitabine is to be administered orally within 30 mins. after the end of a meal. Tablets should be swallowed with approximately 200 mL water (not fruit juices). The first dose of each cycle will be administered as the evening dose on day 1 \& the last dose of each cycle is scheduled the morning of day 15, followed by a 7 day rest period. This provides for a total of 28 single doses per cycle over 15 calendar days.
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen
Measured: The cycle length is 3 weeks, consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startApr 2004
- Primary completionSep 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- New Mexico Cancer Research Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Rabinowitz, MD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250029
- Sponsor's protocol ID
- 0104C
- Status last verified
- Apr 2010
- First submitted
- 3 Nov 2005
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Analysis of Patients With Metastatic Colorectal Cancer Receiving Oxaliplatin Based Chemotherapy
- ClinicalTrials.gov ID
- NCT00250029
- Acronym / sponsor ID
- 0104C
- Conditions
- Colonic Diseases, Cancer
- Keywords
- Colorectal Cancer, Pilot Study, Oxaliplatin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- New Mexico Cancer Research AllianceUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 7 Nov 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.
1.1 To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen.
1.2 To determine a gene expression profile that predicts response to an oxaliplatin based chemotherapy regimen in this cohort of patients.
Detailed description
This is a single-arm, non-randomized trial of oxaliplatin and capecitabine. Patients that are placed on other studies that utilize the same chemotherapy regimen can enter this study. Those patients will be treated according to the clinical study on which they have been entered. For patients not on another clinical trial, the treatment outlined below should be followed.
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 (9 listed)
- All patients, >18 years of age, with metastatic/recurrent colorectal cancer are eligible.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have a Zubrod performance status of 0-2.
- Patients must sign an informed consent.
- Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count > 100,000/mm3 and absence of a regular red blood cell transfusion requirement.
Key exclusion criteria (6 listed)
- Patients with symptomatic brain metastases are excluded from this study.
- Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
- Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
- Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
- Patients may not have received oxaliplatin previously.
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 |
|---|---|---|
| OxaliplatinAlso: XELOX (oxaplatin+capecitabine)Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2 hour intravenous infusion on day 1 of a three week cycle, prior to the 1st dose of capecitabine. 5-HT3 antagonists with or without dexamethasone premedication are strongly recommended. Oxaliplatin may be infused either through a peripheral vein or a central venous line. The infusion lines must be adequately flushed with 5% dextrose solution (D5W) between oxaliplatin infusion \& the administration of any other drug. Capecitabine is to be administered orally within 30 mins. after the end of a meal. Tablets should be swallowed with approximately 200 mL water (not fruit juices). The first dose of each cycle will be administered as the evening dose on day 1 \& the last dose of each cycle is scheduled the morning of day 15, followed by a 7 day rest period. This provides for a total of 28 single doses per cycle over 15 calendar days. | Drug | – |
Primary outcome
To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen
Time frame: The cycle length is 3 weeks, consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment.
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 27 Sep 2011.
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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.
Ian Rabinowitz, MD principal investigator
University of New Mexico
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxaliplatin in people with Colonic Diseases and Cancer, run by New Mexico Cancer Research Alliance at 4 sites 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 9 inclusion and 6 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 27 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
To collect pathological tumor specimens of patients with metastatic colorectal cancer in a prospective fashion for correlative studies of response to an oxaliplatin based chemotherapy regimen (time frame: The cycle length is 3 weeks, consisting of 2 weeks of capecitabine treatment followed by 1 week without 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 27 Sep 2011.