Status:
COMPLETED
Bevacizumab and Cediranib Maleate in Treating Patients With Metastatic or Unresectable Solid Tumor, Lymphoma, Intracranial Glioblastoma, Gliosarcoma or Anaplastic Astrocytoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Grade III Lymphomatoid Granulomatosis
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Eligibility:
All Genders
15+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of bevacizumab and cediranib maleate in treating patients with metastatic or unresectable solid tumor, lymphoma, intracranial glioblastoma...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety and toxicity profile of intravenous bevacizumab (avastin) administered in combination with oral AZD2171 (cediranib maleate) for patients with advanced ma...
Eligibility Criteria
Inclusion
- Patients must have histological confirmation of Solid Tumor or Lymphoma that is metastatic or unresectable; if assessing a single target lesion, histological confirmation of that particular lesion MUST be carried out
- Patients may have received an unlimited number of prior therapies; however, At least 4 weeks MUST have passed since the last chemotherapy to day 1 of registration (6 weeks for regimens containing nitrosoureas or Mitomycin C)
- ECOG performance status =\< 2 (Karnofsky \>= 60%)
- Leukocytes \>= 3,000/mcL
- Absolute neutrophil count \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin =\< 2.0 mg/dL (does NOT apply to patients with Gilbert's Syndrome)
- AST(SGOT)/ALT(SGPT) =\< 2.5 X institutional upper limit of normal (Patients with liver involvement will be allowed =\< 5.0 X institutional upper normal limit)
- Serum creatinine =\< 2.0 mg/dL
- Patients MUST have recovered from all treatment related toxicities to Grade 1 NCI CTC (v 4.0) in severity
- Patients must be willing and able to review, understand, and provide written consent before starting therapy
- Patients with stable brain metastasis (stable disease on one MRI assessment at least 4 weeks after completion of whole brain radiation, no evidence of progression on MRI assessment 4 weeks after stereotactic radiosurgery or complete surgical excision) will also be allowed to participate in this trial
- Patients with histologically proven intracranial glioblastoma, gliosarcoma or anaplastic astrocytoma will be eligible; patients must have shown unequivocal radiographic evidence for tumor progression by MRI scan; scan should be performed within 14 days prior to registration and on a steroid dose that has been stable for at least 5 days; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI is required
Exclusion
- Patients with squamous non-small cell lung carcinoma
- Serious or non-healing wound, ulcer or bone fracture
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days of day 1 of registration
- Invasive procedures defined as follows:
- Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 registration
- Anticipation of need for major surgical procedures during the course of the study
- Core biopsy within 7 days prior to day 1 of therapy
- Patients may not be receiving any other investigational agents
- Patients with bleeding diathesis (clinical bleeding, prothrombin time \>= 1.5 X upper institutional normal value, INR \>= 1.5, activated partial thromboplastin time aPTT \>= 1.5 X upper institutional normal value), active gastric or duodenal ulcer
- Uncontrolled systemic vascular hypertension (Systolic blood pressure \> 140 mmHg, Diastolic Blood Pressure \> 90 mmHg)
- Urine protein should be screened by dipstick or urine analysis; for proteinuria \> 1+ or urine protein:creatinine ratio \> 1.0, 24-hour urine protein should be obtained and the level should be \< 1000 mg for patient enrollment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on Day 1
- Patients with clinically significant cardiovascular disease:
- History of CVA within 6 months
- Myocardial Infarction or unstable angina within 6 months
- New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris
- Clinically significant peripheral vascular disease
- QTc prolongation \> 500msec or other significant ECG abnormality noted within 14 days of registration
- Conditions requiring concurrent use of drugs or biologics with proarrythmic potential; these drugs are prohibited during studies with AZD2171 (refer to appendix V for a listing of these agents)
- Patients with history of hemoptysis
- Patients with tumor mass abutting a major vessel
- Pregnant women are excluded from this study because AZD-2171 is an angiogenesis inhibiting agent with potential teratogenic or abortifacient effects; because of the potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD-2171, breastfeeding should be discontinued if the mother is treated with AZD-2171; these potential risks may also apply to other agents used in this study; women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00458731
Start Date
May 1 2007
Last Update
February 19 2014
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030