A Phase II Trial of RAD001 Plus Bevacizumab in the Treatment of Patients With Metastatic Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Metastatic Melanoma
- Sponsor
- SCRI Development Innovations, LLC
- Enrollment
- 57
- Locations
- 15
- Primary Endpoint
- Progression-free Survival
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in the treatment of metastatic melanoma.
Detailed Description
All patients will begin treatment with the same doses of RAD001 and bevacizumab. Patients will receive 6 weeks of treatment, followed by re evaluation. Patients with objective response or stable disease will continue treatment until disease progression. During the study, all patients will receive 10 mg of RAD001 orally daily and 15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks. Fifty-five patients will be enrolled in this multi-centered study
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed melanoma.
- •Unresectable stage IV disease, or recurrent disease with metastases.
- •Measurable disease (by Response Evaluation Criteria in Solid Tumors \[RECIST\]) or measurable skin lesions.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or
- •Life expectancy \>=12 weeks.
- •Patients are allowed 0-2 prior treatment regimens containing chemotherapy and/or immunotherapy (interferon, interleukin 2).
- •Women of childbearing potential must have a negative serum pregnancy test with 7 days before beginning treatment.
- •Absolute neutrophil count (ANC) \>=1500/µL, and platelets \>=100,000/µL.
- •Serum creatinine \<=2.0 mg/dL.
- •Serum bilirubin \<=1.5 mg/dL institutional upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<2.5 × ULN or \<5 × ULN in patients with documented liver metastases.
Exclusion Criteria
- •Previous treatment with bevacizumab or other anti-angiogenesis agents.
- •Previous treatment with mTOR inhibitors.
- •Drugs or substances known to be inhibitors or inducers of the isoenzyme CYP3A are not allowed.
- •Treatment with investigational agents within 4 weeks of study entry.
- •Treatment with more than two previous chemotherapy regimens.
- •Immunization with attenuated live vaccines within one week of study or anytime during study treatment period.
- •Female patients who are pregnant or breastfeeding.
- •Central nervous system (CNS) involvement by metastatic melanoma.
- •CNS disease (e.g., seizures not controlled with standard medical therapy, history of stroke).
- •Any severe and/or uncontrolled medical conditions or other conditions that could affect participation in the study such as:
Arms & Interventions
Intervention
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
Intervention: Bevacizumab
Intervention
All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
Intervention: Everolimus
Outcomes
Primary Outcomes
Progression-free Survival
Time Frame: 13 months
Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Secondary Outcomes
- Overall Survival Rate(1 year)
- Objective Response Rate (ORR)(13 months)