Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT00006468
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed unresectable metastatic adenocarcinoma of the colon or rectum
* Bidimensionally measurable or evaluable disease outside previously irradiated area
* No bone metastasis as target lesion
* At least 1 cm if spiral CT scan OR
* At least 2 cm if conventional CT scan
* No CNS metastasis
* No symptomatic ascites or pleural effusion that is not evacuated
* No total or partial bowel obstruction
PATIENT CHARACTERISTICS:
Age:
* 18 to 80
Performance status:
* ECOG 0-2
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Alkaline phosphatase less than 5 times upper limit of normal (ULN)
Renal:
* Creatinine less than 3 times ULN
* No uncontrolled hypercalcemia
Cardiovascular:
* No uncontrolled congestive heart failure, angina pectoris, hypertension, or arrhythmias
Other:
* No peripheral sensory neuropathy
* No prior significant neurologic or psychiatric disorders
* No other malignancy within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
* No active infection
* No other concurrent serious disease
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy for metastatic disease
Chemotherapy:
* Prior adjuvant chemotherapy allowed, provided progression-free interval of more than 6 months since end of last course
* No prior oxaliplatin or irinotecan
* No prior chemotherapy for metastatic disease
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No concurrent radiotherapy
Surgery:
* Concurrent surgery allowed
Other:
* At least 30 days since other prior investigational drugs
* No other concurrent investigational treatment
* No other concurrent antitumoral treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00006468
Study Brief:
Protocol Section:
NCT00006468