Status:
COMPLETED
Imatinib, Bevacizumab, and Cyclophosphamide in Patients With Refractory Metastatic Solid Tumors
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Novartis
Conditions:
Unspecified Adult Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Imatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Som...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of imatinib when given together with bevacizumab and metronomic cyclophosphamide in patients with refractory metastatic solid tumors. * Det...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00390156
Start Date
August 1 2006
End Date
January 1 2011
Last Update
July 28 2020
Active Locations (1)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94143-1705