Bevacizumab and Cediranib Maleate in Treating Patients With Metastatic or Unresectable Solid Tumor, Lymphoma, Intracranial Glioblastoma, Gliosarcoma or Anaplastic Astrocytoma
Phase I Clinical Trial Evaluating the Toxicity, Pharmacokinetics and Biological Effect of Intravenous Bevacizumab (Avastin TM) in Combination With Escalating Doses of Oral AZD2171 for Patients With Advanced Malignancies
6 other identifiers
interventional
57
1 country
1
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, gliosarcoma or anaplastic astrocytoma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Cediranib maleate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bevacizumab and cediranib maleate may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving bevacizumab together with cediranib maleate may kill more cancer cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2007
CompletedFirst Posted
Study publicly available on registry
April 11, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedFebruary 19, 2014
December 1, 2013
6.6 years
April 9, 2007
February 14, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Safety and toxicity profile of combination bevacizumab and cediranib maleate
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.
Up to 6 weeks post-treatment
Pharmacokinetic profile of oral cediranib maleate in combination with bevacizumab
Baseline and at 1, 2, 3, 4, 6, 8, and 24 hours after cediranib maleate treatment
Study Arms (1)
Treatment (cediranib maleate and bevacizumab)
EXPERIMENTALPatients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral cediranib maleate once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of bevacizumab and cediranib maleate until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Interventions
Given IV
Given orally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Hong
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2007
First Posted
April 11, 2007
Study Start
May 1, 2007
Primary Completion
December 1, 2013
Last Updated
February 19, 2014
Record last verified: 2013-12