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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT00006103
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the colon or rectum
* Metastatic, locally advanced, or recurrent disease
* Patients must have at least 2 generations (parents and grandparents) who belong to one of the following racial groups:
* Asian or Pacific Islander (e.g., China, Japan, Korea, the Philippine Islands, or Samoa)
* Black (originating from the black racial groups of Africa)
* Hispanic (originating from Mexico, Puerto Rico, Cuba, Central or South America, or other Spanish culture)
* White (originating from the peoples of Europe, North Africa, or the Middle East)
* No patients with parents or grandparents of mixed race or race other than that of the patient
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* CTC 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* AST no greater than 3 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Prior adjuvant fluorouracil allowed if relapse occurred at least 6 months after completion of fluorouracil
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
* No prior irinotecan
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormones except steroids for adrenal failure, hormones for nondisease related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
* No concurrent prednisone
Radiotherapy:
* At least 4 weeks since prior radiotherapy (except to bone or soft tissue involving less than 25% of bone marrow)
* No concurrent radiotherapy
Surgery:
* At least 4 weeks since prior major surgery
Other:
* No concurrent phenobarbital, valproate, or cyclosporine
* None of the following concurrently during first course of therapy:
* Macrolide antibiotics (e.g., azithromycin, erythromycin, clarithromycin, troleandomycin, dapsone)
* Azole antibiotics (e.g., fuconazole, miconazole, itraconazole, ketoconazole)
* Triazobenzodiazepines (e.g., alprazolam, midazolam, triazolam)
* Antidepressants (e.g., fluoxetine, setraline hydrochloride, fluoxamine, nefazodone hydrochloride)
* Quinolone antimicrobials (e.g., ciprofloxacin, ofloxacin)
* Imidazole antibiotics (e.g., clotrimazole)
* Anti-ulcer medications (e.g., omeprazole, lansoprazole)
* Ethinyl estradiol
* Diltiazem
* Cimetidine hydrochloride
* Cisapride
* Terfenadine
* Rifampin
* Glucocorticoids
* Antiepileptics
* Grapefruit juice
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00006103
Study Brief:
Protocol Section:
NCT00006103