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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT00390156
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of solid tumor
* Advanced or metastatic disease\* NOTE: \*With the exception of colorectal and lung cancer patients, all patients must receive approval from the insurance carrier that allows for coverage/payment of the study drug bevacizumab
* Refractory to standard therapy OR no standard therapy exists
* No advanced ovarian cancer or peritoneal carcinomatosis
* No metastases from any cancer causing significant ascites
* No lung malignancy with any of the following characteristics:
* In close proximity to a major vessel
* Centrally located
* Cavitary
* Squamous histology
* Hemoptysis \> ½ teaspoon per day
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Platelet count ≥ 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Bilirubin \< 2 mg/dL
* AST or ALT \< 3 times upper limit of normal
* Creatinine \< 2 mg/dL
* Urine protein:creatinine ratio ≤ 1.0
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to tolerate oral therapy
* No bleeding diatheses or coagulopathy
* No impairment of gastrointestinal (GI) function or GI disease that may affect or alter absorption of imatinib mesylate and/or cyclophosphamide (e.g., malabsorption syndrome, history of total gastrectomy/significant small bowel resection)
* No abdominal fistula, GI perforation, or intra-abdominal abscess within the past 6 months
* No uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg)
* No uncontrolled cardiovascular disease, including any of the following:
* Coronary artery disease
* Uncontrolled cardiac arrhythmia
* Symptomatic congestive heart failure (i.e., New York Heart Association class II-IV)
* Unstable angina pectoris
* Clinically significant peripheral vascular disease
* No arterial thromboses within the past year, including any of the following:
* Transient ischemic attack
* Myocardial infarction
* Cerebrovascular event
* Unstable angina
* Angina requiring medical or surgical intervention
* Clinically significant peripheral artery disease
* Any other arterial thromboembolic event
* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* No serious nonhealing wound, ulcer, or bone fracture
* No other active second malignancy except nonmelanoma skin cancer or cervical carcinoma in situ unless therapy has been completed and \< 30% risk for relapse exists
* No active infection or known HIV infection
* No history of allergic reactions (≥ grade 3 or 4) to compounds of similar chemical or biologic composition to cyclophosphamide (i.e., alkylating agents)
* No history of noncompliance with medical regimens
* No known intolerance or hypersensitivity reaction to bevacizumab, imatinib mesylate, or cyclophosphamide
* No other significant medical illness, psychiatric illness, or social situation that, in the opinion of the investigator, would limit compliance with study requirements
* No inability to grant reliable informed consent
PRIOR CONCURRENT THERAPY:
* No major surgical procedure within the past 28 days or anticipated major surgery during study treatment except for placement of a venous access device or surgery for a diagnostic study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00390156
Study Brief:
Protocol Section:
NCT00390156