Status:
COMPLETED
Erlotinib and Bevacizumab in Treating Patients With Stage IV Melanoma
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Erlotinib 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. So...
Detailed Description
OBJECTIVES: Primary * Determine the overall response rate, response duration, and frequency of progression-free survival at 6 months in patients with stage IV melanoma treated with erlotinib hydroch...
Eligibility Criteria
Inclusion
- Measurable Stage IV melanoma
- Easter Cooperative Oncology Group (ECOG) Performance Status must be 0-1
- Good organ function as demonstrated by, Creatinine \<2.mg/dl, AST or ALT \<5 times upper limit of normal for subjects with documented liver metastases; \<2.5 times the upper limit of normal (ULN) for subjects without evidence of liver metastases, bilirubin\<2.0mg/dl,, absolute neutrophil count (ANC)\>1500/ul, platelets\>75k/ul, hemoglobin (Hgb)\>9 (may be transfused to obtain)
- Prior therapy: adjuvant interferon (IFN) allowed; no more than one prior regimen for advanced stage IV disease
- Patients must have a life expectancy of \>3 months
- Patients with brain metastases are eligible only if they fulfill the following: resected or stereotactic treatment a minimum of 3 months previously and no active CNS disease since then; brain metastases treated greater than 6 months ago without evidence of progression or hemorrhage, \<1cm in size per lesion (up to 3 lesions), and off all steroids
- Patients may not have received other agents, either investigational or marketed, which act by either EGFr inhibition or anti-angiogenesis mechanisms. Other epidermal growth factor receptor (EGFR) inhibitors include (but are not limited to): Iressa, erbitux, CI-1033. Angiogenesis inhibitors include (but are not limited to): SU5416, SU6668, SU 0122348, CP547632, VEGF Trap, anti-integrin αVβ3.
- Recovered from toxicity of major surgery (4 wks), chemotherapy or biologic therapy (4 wks), and/or radiation therapy (2 wks)
- No active other malignancy within 12 months
- No active systemic infection
- Over age of 18 years and signed IRB approved informed consent
Exclusion
- Subjects meeting any of the following criteria (3.2.2-3.2.16) are ineligible for study entry
- Compromised renal or hepatic function as defined by Creatinine \>2.0mg/dl, aspartate transaminase (AST) or alanine transaminase (ALT) \>5 times upper limit of normal for subjects with documented liver metastases; \>2.5 times the upper limit of normal (ULN) for subjects without evidence of liver metastases
- Patient may not be part of any other investigational studies
- internationalized normal ratio (INR) \> 1.5
- Patients with PEG or G-tube are ineligible.
- Major surgical procedure, open biopsy; or significant traumatic injury within 28 days, or anticipation of need for major surgical procedure during the course of the study
- Any non-healing wound, ulcer, or bone fracture.
- Any clinical evidence or history of a bleeding diathesis or coagulopathy.
- Patients with a history of deep vein thrombosis or thromboembolic disease within the past 6 months.
- History of acute myocardial infarction within 6 months. In addition, patients are ineligible if they have clinically significant cardiovascular disease ((e.g., uncontrolled hypertension \[blood pressure of \>160/110 mmHg on medication\], New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (Grade II or greater)
- Patients with \> 1+ proteinuria will have 24-hour urine collection; for protein. Patients with ≥ 1gm protein/24 hrs will be excluded
- If child bearing age must not be pregnant or nursing and use methods to prevent pregnancy
- History or evidence upon physical examination of central nervous system (CNS) disease (e.g., primary brain tumor, seizures not controlled with standard medical therapy, or history of stroke)
- Inability to comply with study and/or follow-up procedures
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00466687
Start Date
September 1 2004
End Date
September 1 2008
Last Update
July 22 2013
Active Locations (4)
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1
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37067-1631
2
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37067
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
4
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838