Informations générales (source: ClinicalTrials.gov)
Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study
Interventional
Phase 2
Institut Cancerologie de l'Ouest (Voir sur ClinicalTrials)
septembre 2007
29 juin 2024
RATIONALE: Studying samples of blood in the laboratory from patients receiving
oxaliplatin for cancer may help doctors learn more about changes that occur in DNA and
identify biomarkers related to neurotoxicity.
PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in
patients with colorectal cancer receiving oxaliplatin.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Paul Papin - 49036 - Angers - France | Erick Gamelin, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Requires treatment with oxaliplatin (as part of a FOLFOX regimen)
- No brain metastases or symptomatic meningitis
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy > 3 months
- ANC ≥ 1 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- Transaminases ≤ 3 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior or concurrent clinical neuropathy (regardless of the etiology)
- No dihydropyrimidine dehydrogenase deficiency
- No psychiatric illness that would preclude comprehension of the study or of the
informed consent
- No other severe illness that may worsen during treatment, including unstable cardiac
disease, myocardial infarction within the past 6 months, or active uncontrolled
infection
- No psychological, social, familial, or geographical reason that would preclude study
follow-up
- Other cancer within the past 5 years allowed provided treatment did not include
platinum derivatives or taxanes
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior chemotherapy allowed (except for platinum derivatives or taxanes)
- Histologically confirmed colorectal cancer
- Requires treatment with oxaliplatin (as part of a FOLFOX regimen)
- No brain metastases or symptomatic meningitis
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Life expectancy > 3 months
- ANC ≥ 1 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- Transaminases ≤ 3 times ULN
- Alkaline phosphatase ≤ 5 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No prior or concurrent clinical neuropathy (regardless of the etiology)
- No dihydropyrimidine dehydrogenase deficiency
- No psychiatric illness that would preclude comprehension of the study or of the
informed consent
- No other severe illness that may worsen during treatment, including unstable cardiac
disease, myocardial infarction within the past 6 months, or active uncontrolled
infection
- No psychological, social, familial, or geographical reason that would preclude study
follow-up
- Other cancer within the past 5 years allowed provided treatment did not include
platinum derivatives or taxanes
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior chemotherapy allowed (except for platinum derivatives or taxanes)