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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT00003995
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV colorectal cancer with p185 HER2 overexpression
* Bidimensionally measurable disease Indicator lesion must be outside of irradiated field No symptomatic CNS brain metastases
PATIENT CHARACTERISTICS:
* Performance status: ECOG 0-2
* Absolute granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 3.0 times ULN
* Creatinine no greater than 2.0 mg/dL
* LVEF at least 45% by MUGA or ECHO
* No myocardial infarction within the past 6 months
* No congestive heart failure
* No unstable angina
* No clinically significant pericardial effusion or arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
* No other prior malignancy within the past 5 years, except:
* Curatively treated basal or squamous cell skin cancer
* Curatively treated carcinoma in situ of the cervix
* No active serious infection or serious underlying medical condition that would prevent compliance
* No dementia or significantly altered mental status
PRIOR CONCURRENT THERAPY:
* Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa allowed
* No prior trastuzumab
* No more than 1 prior chemotherapy regimen for advanced disease (if progressed during or within 6 months of adjuvant therapy considered to have had 1 regimen for advanced disease)
* No prior irinotecan
* Concurrent contraception, estrogen replacement therapy, or megestrol acetate for anorexia allowed
* Greater than 3 weeks since prior radiotherapy and recovered
* Greater than 3 weeks since major surgery (except simple biopsy or venous access placement) and recovered
* At least 3 weeks since prior investigational nonneoplastic drugs
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00003995
Study Brief:
Protocol Section:
NCT00003995