Phase 2
N=149
Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma
Melanoma (Skin)
Bottom Line
View on ClinicalTrials.gov: NCT00976573 ↗Enrolled (actual)
149
Serious AEs
21.1%
Results posted
Mar 2017
Primary outcome: Primary: Progression-free Survival — 5.6; 5.1 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Biological); carboplatin (Drug); everolimus (Drug); paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
5.6; 5.1 | — |
| SECONDARY Toxicity |
35; 58; 17; 24; 11; 17 | — |
| SECONDARY Confirmed Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria |
13; 23 | — |
| SECONDARY Overall Survival Time |
14.5; 10.8 | — |
Summary
This randomized phase II trial is studying how well carboplatin, paclitaxel, and bevacizumab work when given with or without everolimus in treating patients with malignant melanoma that has spread from where it started to other places in the body. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may block the ability of tumor cells to grow and spread. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy given together with bevacizumab is more effective with or without everolimus in treating patients with metastatic melanoma.
Eligibility Criteria
Inclusion Criteria
- Histologic proof of stage IV malignant melanoma not amenable to surgery; (biopsy can be of locoregional disease in setting of clinically evident stage IV disease, but primary tumor alone will not qualify)
- At most one prior chemotherapy based regimen for metastatic melanoma (no prior taxane-based regimens allowed); note: prior adjuvant non-taxane based chemotherapy and/or adjuvant immunotherapy are allowed; no limit on the number of prior biologic, immunologic or targeted therapies
- Measurable disease defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm with chest x-ray, or as >= 1.0 cm with computed tomography (CT) scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) scan; note: disease that is measurable by physical examination only is not eligible
- Life expectancy >= 4 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Absolute neutrophil count (ANC) >= 1500/mL
- Platelets (PLT) >= 100,000 x 10^9/L
- Hemoglobin (Hgb) >= 9 g/dL (patients may be transfused to meet this requirement)
- Total cholesterol = = 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate = =150 mm Hg systolic and/or 100 mmHg diastolic) despite treatment
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Myocardial infarction or unstable angina = 1.5 x ULN
- Severely impaired lung function as defined as spirometry and diffusing capacity of the lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or 02 saturation that is 88% or less at rest on room air
- A known history of human immunodeficiency virus (HIV) seropositivity
- Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- Pregnant women
- Nursing women
- Men and women of reproductive potential who are not using effective birth control methods must use highly effective contraception throughout the trail and for 6 months after last study treatment
- Existence of peripheral sensory neuropathy >= grade 2
- History of other malignancy = 25% of their functional bone marrow irradiated are not eligible for this trial
- Active or recent history of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) = = 7 days after discontinuation of such agent
- Positive hepatitis B antigen (HBsAg) or hepatitis C serology (HCV) tests
- Planned immunization with attenuated live vaccines =< 7 days prior to registration or during study period; note: close contact with those who have received attenuated live vaccines should be avoided during treatment with everolimus; examples of live vaccines include intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin (BCG), yellow fever, varicella and TY21a typhoid vaccines
Data sourced from ClinicalTrials.gov (NCT00976573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.