Overview

Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ICO Paul Papin
Institut Cancerologie de l'Ouest
Treatments:
Calcium
Fluorouracil
Leucovorin
Levoleucovorin
Oxaliplatin
Criteria
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)