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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT00359606
Eligibility Criteria:
Inclusion Criteria:
* Advanced, histologically-confirmed neoplastic disease refractory to standard therapy or for which no standard therapy exists
* Karnofsky performance status of at least 60% and estimated survival of at least two months
* Serum creatinine =\< 2.0 mg/dl or creatinine clearance \>= 50 ml/min
* Absolute neutrophil count (ANC) \>= 1,500/ul
* Platelets \>= 125,000/ul
* Bilirubin =\< 1.5 mg/dl
* Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 3 times the upper limits of normal
* Prior antineoplastic therapy must have been completed at least four weeks prior to the patient's entry on this study, or patients must have recovered from any expected side effects of the prior therapy; there is no limit on the number of cycles of prior chemotherapy
* Patients must be ineligible for or have refused participation in higher priority institutional protocols
* Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
* Pregnant patients are INELIGIBLE; all patients of child-bearing potential, both male and female, must be advised to practice adequate contraception; premenopausal women must have a negative pregnancy test prior to entry on this study
* Patients with any non-malignant intercurrent illness (e.g. cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it inappropriate to treat the patient on this protocol are INELIGIBLE
* Patients currently being treated for a severe infection or who are recovering from major surgery are INELIGIBLE until recovery is deemed complete by the investigators
* The presence of measurable disease is NOT required for this phase I study; if bidimensionally measurable disease is present, baseline measurements of up to 3 indicator lesions should be made no earlier than four weeks prior to the first cycle of chemotherapy; pleural effusions, ascites and bone metastases are not considered measurable
* Complete blood count (CBC), differential count, platelet count, and blood chemistries should be done no earlier than 72 hours prior to each cycle of chemotherapy
* Pretreatment tests should be done no earlier than two weeks prior to the first cycle of chemotherapy
* Priority for accrual will be given to patients with breast cancer due to the in vitro data suggesting potential activity for this disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00359606
Study Brief:
Protocol Section:
NCT00359606