Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery

Conditions

• Recurrent Uveal Melanoma
• Stage III Uveal Melanoma AJCC v7
• Stage IIIA Uveal Melanoma AJCC v7
• Stage IIIB Uveal Melanoma AJCC v7
• Stage IIIC Uveal Melanoma AJCC v7
• Stage IV Uveal Melanoma AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib S-malate — DRUG
  Given PO
• Dacarbazine — DRUG
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Temozolomide — DRUG
  Given PO

Study Details

This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma) that has spread to other parts of the body and cannot be removed by surgery. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, 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. It is not yet known whether cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with melanoma of the eye.

Key Dates

Start date

Jul 31, 2013

Status verified

Aug 2022

Primary completion

Oct 21, 2016

Completion

Nov 1, 2019

Study Design

Enrollment

47 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (cabozantinib-s-malate)
  Patients receive cabozantinib-s-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (temozolomide or dacarbazine)
  Patients receive temozolomide PO daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. If temozolomide is not available, patients receive dacarbazine IV over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Proportion of Patients Without a Progression Free Survival Event at 4 Months (PFS4) [ Time Frame: At 4 months ]

Locations (224)

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