Phase 2
N=120
Temozolomide or Selumetinib in Treating Patients With Metastatic Melanoma of the Eye
Iris Melanoma · Medium/Large Size Posterior Uveal Melanoma · Ocular Melanoma With Extraocular Extension · Recurrent Uveal Melanoma · Small Size Posterior Uveal Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01143402 ↗Enrolled (actual)
120
Serious AEs
37.6%
Results posted
May 2017
Primary outcome: Primary: Progression-free Survival (PFS) (Evaluable Randomized Patients) — 7; 15.9 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dacarbazine (Drug); Laboratory Biomarker Analysis (Other); Quality-of-Life Assessment (Other); Selumetinib (Drug); Temozolomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) (Evaluable Randomized Patients) |
7; 15.9 | — |
| SECONDARY Median Overall Survival (Evaluable Randomized Patients) |
9.1; 11.8 | — |
Summary
This randomized phase II trial studies temozolomide to see how well it works compared to selumetinib in treating patients with melanoma of the eye that has spread to other places in the body. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective than selumetinib in treating melanoma of the eye.
Eligibility Criteria
Inclusion Criteria
- Patients must have metastatic histologically or cytologically confirmed uveal melanoma; if histologic or cytologic confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma; pathologic confirmation of diagnosis will be performed at Memorial Sloan-Kettering Cancer Center (MSKCC) or at a participating site
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan
- Life expectancy of greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 9.0 g/dL (not requiring transfusions within the past 2 weeks)
- Total bilirubin = 450 msecs or other factors that increase the risk of QTc prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class III and IV definitions are excluded
- Every effort must be made to avoid the use of a concomitant medication that can prolong the QTc interval while receiving AZD6244; if the patient cannot discontinue medications that prolong the QTc interval while receiving AZD6244, close cardiac monitoring should be performed
Data sourced from ClinicalTrials.gov (NCT01143402). 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.