Phase 2
N=25
Sorafenib, Carboplatin, and Paclitaxel in Treating Patients With Stage IV Melanoma of the Eye
Ciliary Body and Choroid Melanoma, Medium/Large Size · Extraocular Extension Melanoma · Iris Melanoma · Metastatic Intraocular Melanoma · Recurrent Intraocular Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00329641 ↗Enrolled (actual)
25
Serious AEs
8.3%
Results posted
Jul 2012
Primary outcome: Primary: Response Rate (Complete and Partial Response) — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- carboplatin (Drug); paclitaxel (Drug); sorafenib tosylate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (Complete and Partial Response) |
— | — |
| SECONDARY One-year Overall Survival |
42 | — |
| SECONDARY 6-month Progression-free Survival |
29 | — |
| SECONDARY Toxicity |
1; 1; 2; 1; 1; 2 | — |
Summary
This phase II trial is studying how well sorafenib works when given together with carboplatin and paclitaxel in treating patients with stage IV melanoma of the eye. 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. Sorafenib may help carboplatin and paclitaxel work better by making tumor cells more sensitive to the drugs. Sorafenib may also stop the growth of melanoma by blocking some of the enzymes needed for tumor cell growth and by blocking blood flow to the tumor. Giving sorafenib together with carboplatin and paclitaxel may kill more tumor cells.
Eligibility Criteria
Criteria:
- Histologically proven uveal melanoma
- Must have documented disease progression during or after = = 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
- No tumor involving major vessels
- Zubrod performance status 0-1
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Creatinine = 140 mm Hg or diastolic BP > 90 mm Hg
- No significant traumatic injury within the past 21 days
- No active, uncontrolled peptic ulcer disease
Data sourced from ClinicalTrials.gov (NCT00329641). 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.