Metastatic Colorectal CancerPhase 4NCT00138060
Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
A Phase 4 study testing irinotecan and 5 fluorouracil in people with Metastatic Colorectal Cancer, run by Institut de Recherche Clinique sur les Cancers et le Sang at 6 sites in France.
Trial summary
This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1 (UGT1A1) polymorphisms before the first administration. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- irinotecan and 5 fluorouracil
- How many people
- 71 participants
- Where
- 6 sitesFrance
- Study dates
- Jun 2005to Dec 2008
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has provided 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
- Ages between 18 and 85 years
- Histologically confirmed colorectal cancer
- No treatment for metastatic disease
- No irinotecan previously administered
- World Health Organization (WHO) performance status < 3
Show all 14Show fewer
- Laboratory values :
- neutrophils > 1.5 x 10^9/L;
- platelet count > 100 x 10^9/L;
- serum creatinine < 130µmol/L;
- serum bilirubin < 2 x upper limit of normal (ULN);
- ASAT and ALAT < 2.5 x ULN;
- alkaline phosphatase < 5 x ULN.
- At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Who cannot join
- History of another malignancy except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix, breast or bladder.
- Other concomitant anticancer therapy.
- Pregnant or lactating women.
- Women of childbearing potential unless using a reliable and appropriate contraceptive method.
- Symptomatic cerebral or leptospiral metastasis.
- Intestinal obstruction.
Show all 10Show fewer
- Uncontrolled seizures (diabetes, severe infection).
- Clinically significant cardiac disease.
- Central nervous system disorders or severe psychiatric disability.
- Participation in any investigational study within 4 weeks.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Department of Oncology, CHU
Grenoble, 38043
Department of Oncology, IPC
Grenoble, 38100
Department of Gastroenterology, CHLS
Pierre-Bénite, 69310
Department of Oncology - CHLS
Pierre-Bénite, 69310
Department of Oncology, ICL
Saint-Priest-en-Jarez, 42271
Institut Claudius Regaud
Toulouse
About this study
Official title: Protocole Evaluant Chez Des Patients Porteurs de Cancers Colorectaux Metastatiques l'Interet Des Determinants Genotypiques Pour l'Optimisation de l'Efficacite et de la Tolerance de la Chimiotherapie Par Irinotecan et 5-fluorouracile
This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1 (UGT1A1) polymorphisms before the first administration.
The results of this identification determine the chemotherapy type: high-dose irinotecan or not.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- irinotecan, 5 fluorouracil
- Keywords
- genotypic profile, metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irinotecanDrug
180 mg/m² or 260 mg/m² in 90 minutes every 15 days
5 fluorouracilDrug
400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor response rate
Measured: during the treatment
Secondary outcomes (2)
toxicity
Measured: during the treatment
pharmacokinetics
Measured: during the first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startJun 2005
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche Clinique sur les Cancers et le Sang
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Gilles Freyer, MD, Principal investigator, Department of Oncology, CHLS, 69310 Pierre Benite, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138060
- Sponsor's protocol ID
- COLOGEN
- Status last verified
- Jul 2010
- First submitted
- 26 Aug 2005
- Last updated
- 20 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Iyer L, Das S, Janisch L, Wen M, Ramirez J, Karrison T, Fleming GF, Vokes EE, Schilsky RL, Ratain MJ. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J. 2002;2(1):43-7. doi: 10.1038/sj.tpj.6500072.
PubMed 11990381
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocole Evaluant Chez Des Patients Porteurs de Cancers Colorectaux Metastatiques l'Interet Des Determinants Genotypiques Pour l'Optimisation de l'Efficacite et de la Tolerance de la Chimiotherapie Par Irinotecan et 5-fluorouracile
- ClinicalTrials.gov ID
- NCT00138060
- Acronym / sponsor ID
- COLOGEN
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- genotypic profile, metastatic colorectal cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Institut de Recherche Clinique sur les Cancers et le SangUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Aug 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 intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1 (UGT1A1) polymorphisms before the first administration.
The results of this identification determine the chemotherapy type: high-dose irinotecan or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Has provided 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
- Ages between 18 and 85 years
- Histologically confirmed colorectal cancer
- No treatment for metastatic disease
- No irinotecan previously administered
Key exclusion criteria (10 listed)
- History of another malignancy except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix, breast or bladder.
- Other concomitant anticancer therapy.
- Pregnant or lactating women.
- Women of childbearing potential unless using a reliable and appropriate contraceptive method.
- Symptomatic cerebral or leptospiral metastasis.
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 |
|---|---|---|
| irinotecan180 mg/m² or 260 mg/m² in 90 minutes every 15 days | Drug | – |
| 5 fluorouracil400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion | Drug | – |
Primary outcome
tumor response rate
Time frame: during the treatment
2 secondary outcomes
toxicity
Time frame: during the treatment
pharmacokinetics
Time frame: during the first administration
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 20 Jul 2010.
- Background: PubMed 11990381Iyer L, Das S, Janisch L, Wen M, Ramirez J, Karrison T, Fleming GF, Vokes EE, Schilsky RL, Ratain MJ. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J. 2002;2(1):43-7. doi: 10.1038/sj.tpj.6500072.
Related trials for Metastatic 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
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
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.
Gilles Freyer, MD principal investigator
Department of Oncology, CHLS, 69310 Pierre Benite, France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing irinotecan and 5 fluorouracil in people with Metastatic Colorectal Cancer, run by Institut de Recherche Clinique sur les Cancers et le Sang at 6 sites in France.
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 14 inclusion and 10 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 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 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?
tumor response rate (time frame: during the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00138060, which also lists 1 linked publication.
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 20 Jul 2010.