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:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT00005818
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed adenocarcinoma of the colon or rectum
* Patients must have locally advanced or metastatic disease not amendable to potentially curative treatment
* Patients must have an ECOG performance status of 0-2
* Men and women of any racial and ethnic group
* Absolute neutrophil count (neutrophils + bands) of \>= 1,500/ul
* Platelet count of \>= 100,000/ul
* Patients must have a serum creatinine of =\< 1.5 mg/dL or a calculated creatinine clearance \>= 60 mL/min
* Serum bilirubin =\< 1.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor
* SGOT must be =\< 3 times institutional upper limit of normal
* Patients must be fully recovered from any previous surgery (at least 4 weeks from major surgery)
* Patients must have recovered from prior radiation therapy (at least 4 weeks from radiation)
* Fertile patients (male and female) must agree to use a medically effective contraceptive method throughout the treatment period and for 3 months following cessation of treatment
* Patients must provide written informed consent
* Patients must have either measurable or evaluable disease; measurable disease is defined as at least one bidimensionally measurable lesion \>= 1 x 1 cm that is outside the field of any prior radiation therapy
* In Phase I: Patients with a history of a prior malignancy are eligible for treatment
* In Phase II: Patients who have undergone potentially curative therapy for a prior malignancy and who have had no evidence of that disease for \> 5 years are eligible for treatment; adequately treated basal cell or squamous cell skin cancer does not apply
* In the Phase I portion of the study the following eligibility criteria must be met:
* Patients must have received no more than two prior chemotherapy regimens (one of which must have contained a fluorinated pyrimidine) for locally advanced or metastatic disease; if a patient progressed while on or within 6 months of adjuvant therapy, the adjuvant regimen will be considered as treatment for metastatic disease
* In the Phase II portion of the study the following eligibility criteria must be met:
* Patients must have received one and only one prior chemotherapy regimen, which must have contained a fluorinated pyrimidine, for treatment of locally advanced or metastatic disease; if a patient progressed while on or within 6 months of adjuvant therapy, the adjuvant regimen will be considered as treatment for metastatic disease
Exclusion Criteria:
* Patients who have previously received SU5416, CPT-11, or any topoisomerase I inhibitor
* Patients with uncompensated coronary artery disease on electrocardiogram or physical examination, or with a history of myocardial infarction, or severe/unstable angina in the past 6 months are not eligible
* Patients with diabetes mellitus with severe peripheral vascular disease and patients who have had a deep venous or arterial thrombosis (including pulmonary embolism) within 3 months of entry are not eligible
* Patients with known allergy to Cremaphor, or Cremophor-based drug products
* Patients with any active or uncontrolled infection
* Patients with psychiatric disorders that would interfere with consent or follow-up
* CPT-11 is known to have teratogenic potential and may be excreted in milk; the current SU5416 Investigator's Brocure indicates that teratogenicity studies have not yet been performed; however, other antiangiogenesis drugs, such as thalidomide, are known to have teratogenic potential; based on the available data, there is potential for significant risk to a developing fetus or breast-feeding child; therefore, pregnant women, women who are breast-feeding, and fertile men and women, unless utilizing birth control are excluded from this study; a negative pregnancy test must be documented during the screening period for women of childbearing potential
* Patients with either a prior history of or clinically apparent central nervous system metastases or leptomeningeal carcinomatosis disease
* Patients with a history of seizures or who are receiving phenytoin, phenobarbital, or other antipileptic prophylaxis
* Patients with uncontrolled diabetes mellitus
* Patients with known Gilbert's Disease (may have excessive CPT-11-induced toxicity)
* Patients with any other severe concurrent disease which in the judgement of the investigator would make the patient inappropriate for the study
* Patients who have received any investigational drug =\< 30 days prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005818
Study Brief:
Protocol Section:
NCT00005818