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

Completed · Phase 2

Conditions studied: 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

In brief

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 facts

Study ID: NCT01835145
Run by: National Cancer Institute (NCI)
People needed: 47
Starts: 2013-07-31
Expected to finish: 2019-11-01
Last updated by the study team: 2022-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed uveal melanoma that is metastatic or unresectable; 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 the participating site
Measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI)
Prior systemic therapies allowed, except for those treatments directed toward, or with activity against, c-Met or vascular endothelial growth factor/receptor (VEGF/R), and the chemotherapy agents temozolomide and dacarbazine; prior treatment must have been no earlier than 3 weeks prior to starting treatment with cabozantinib with exceptions noted below and the following: at least 4 weeks since prior hepatic infusion or at least 2 weeks since radiation therapy
No cytotoxic chemotherapy including investigational cytotoxic chemotherapy or biologic agents (e.g., cytokines or antibodies) within the last 3 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment; at least 6 weeks must have elapsed if the last regimen included an anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) antibody; patients must have experienced disease progression on their prior therapy in the opinion of the treating investigator
No prior radiation therapy within the last 4 weeks, except as below
To the thoracic cavity, abdomen, or pelvis within 12 weeks before the first dose of study treatment, or has ongoing complications, or is without complete recovery to < grade 1 toxicity
To bone or brain metastasis within 14 days before the first dose of study treatment
To any other site(s) within 28 days before the first dose of study treatment
Prior radiation treatment may have included no more than 3000 centigray (cGy) to fields including substantial bone marrow
No prior radionuclide treatment within 6 weeks of the first dose of study treatment
No prior treatment with a small molecule kinase inhibitor or a hormonal therapy within 14 days or 5 half-lives (whichever is longer)
No concomitant anti-cancer therapy unless specified above
Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
A corrected QT interval calculated by the Fridericia formula (QTcF) =< 500 ms within 28 days before randomization; Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed; if the average of these three consecutive results for QTcF is =< 500 ms, the patient meets eligibility in this regard
Common Terminology Criteria for Adverse Events (CTCAE) recovered to baseline or CTCAE =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
No active brain metastases or epidural disease; patients with brain metastases previously treated with whole brain radiation or radiosurgery or patients with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible; neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 12 weeks before starting study treatment; baseline brain imaging with contrast-enhanced CT or MRI scans for patients with known brain metastases is required to confirm eligibility
No clinically significant gastrointestinal bleeding within 24 weeks before the first dose of study treatment
No hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood within 12 weeks before the first dose of study treatment
No signs indicative of pulmonary hemorrhage within 12 weeks before the first dose of study treatment
No prior radiographic evidence of cavitating pulmonary lesion(s)
No tumor in contact with, invading or encasing any major blood vessels
No evidence of tumor invading the gastrointestinal (GI) tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of treatment
The patient may not have uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Cardiovascular disorders including:
Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening

Where it is running

Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
Alaska Women's Cancer Care — Anchorage, Alaska, United States
Anchorage Oncology Centre — Anchorage, Alaska, United States
Katmai Oncology Group — Anchorage, Alaska, United States
Providence Alaska Medical Center — Anchorage, Alaska, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
Beebe Medical Center — Lewes, Delaware, United States
Christiana Gynecologic Oncology LLC — Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA — Newark, Delaware, United States
Helen F Graham Cancer Center — Newark, Delaware, United States
Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
Beebe Health Campus — Rehoboth Beach, Delaware, United States
TidalHealth Nanticoke / Allen Cancer Center — Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital — Wilmington, Delaware, United States
Holy Cross Hospital — Fort Lauderdale, Florida, United States
Jupiter Medical Center — Jupiter, Florida, United States
Mount Sinai Medical Center — Miami Beach, Florida, United States
Saint Luke's Cancer Institute - Boise — Boise, Idaho, United States
Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian — Meridian, Idaho, United States
University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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