Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01835145 |
Recruitment Status
:
Completed
First Posted
: April 18, 2013
Last Update Posted
: February 28, 2018
|
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- No Results Posted
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 | Drug: Cabozantinib S-malate Drug: Dacarbazine Other: Laboratory Biomarker Analysis Drug: Temozolomide | Phase 2 |
PRIMARY OBJECTIVES:
I. Compare the progression-free survival rate at 4 months (PFS4) of patients with ocular melanoma treated with cabozantinib-s-malate (cabozantinib) or temozolomide (or dacarbazine).
SECONDARY OBJECTIVES:
I. Estimate the distribution of progression-free survival (PFS) times. II. Estimate the distribution of overall survival (OS) times. III. Estimate the confirmed response rate as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
IV. Assess the safety of these agents by examining the toxicity profile. V. Correlate the response of MET molecular status.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM II: 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 intravenously (IV) over 15-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 12 weeks for 2 years.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 47 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide/Dacarbazine in Ocular Melanoma |
Actual Study Start Date : | July 31, 2013 |
Actual Primary Completion Date : | October 21, 2016 |
Actual Study Completion Date : | October 21, 2016 |

Arm | Intervention/treatment |
---|---|
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.
|
Drug: Cabozantinib S-malate
Given PO
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
|
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.
|
Drug: Dacarbazine
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Temozolomide
Given PO
Other Names:
|
- PFS4 [ Time Frame: At 4 months ]A patient will be declared a PFS4 success if they are on study and progression free for at least 4 months. This study will be declared promising if a one-sided chi-squared test for a difference in PFS4 rates yields a p-value of less than 0.10.
- Confirmed response rate as determined by the RECIST criteria (version 1.1) [ Time Frame: Up to 2 years ]The confirmed response rates will be estimated by dividing the number of confirmed responders by the number of evaluable patients. 95% confidence intervals will be calculated.
- Maximum grade for each type of adverse event, graded according to the National Cancer Institute CTCAE version 4.0 [ Time Frame: Up to 2 years ]Frequency tables will be created to look for patterns.
- Overall survival (OS) [ Time Frame: Number of days from registration until death, assessed up to 2 years ]The distribution of OS time will be estimated using the method of Kaplan Meier.
- PFS [ Time Frame: Number of days from registration until disease progression (or death), assessed up to 2 years ]The distribution of PFS time will be estimated using the method of Kaplan Meier.
- Pre-treatment GNAQ/GNA11 and potentially other mutations in tissue [ Time Frame: Baseline ]The proportions of patient's within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.
- Pre-treatment immune gene expression in tissue defined as T cell-inflamed, intermediate and non-T cell-inflamed [ Time Frame: Baseline ]The proportions of patient's within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 140 mmHg systolic, or > 90 mmHg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
- Any history of congenital long QT syndrome
-
Any of the following within 24 weeks before the first dose of study treatment:
- Unstable angina pectoris
- Clinically-significant cardiac arrhythmias
- Stroke (including transient ischemic attack [TIA], or other ischemic event)
- Myocardial infarction
- Thromboembolic event requiring therapeutic anticoagulation (Note: patients with a venous filter [e.g. vena cava filter] are not eligible for this study)
-
Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
-
Any of the following within 28 days before the first dose of study treatment
- Intra-abdominal tumor/metastases invading GI mucosa
- Active peptic ulcer disease
- Inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis
- Malabsorption syndrome
-
Any of the following within 24 weeks before the first dose of study treatment:
- Abdominal fistula
- Gastrointestinal perforation
- Intra-abdominal abscess; Note: complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more that 24 weeks before the first dose of study treatment
- Bowel obstruction or gastric outlet obstruction
-
-
Other clinically significant disorders such as:
- Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
- History of organ transplant
- Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
-
History of major surgery as follows:
- Major surgery in past 8 weeks of the first dose of cabozantinib if there were no wound healing complications or within 24 weeks of the first dose of cabozantinib if there were wound complications
- Minor surgery within 4 weeks of the first dose of cabozantinib if there were no wound healing complications or within 12 weeks of the first dose of cabozantinib if there were wound complications
- In addition, complete wound healing from prior surgery must be confirmed at least 28 days before the first dose of cabozantinib irrespective of the time from surgery
- Active infection requiring systemic treatment within 28 days before the first dose of study treatment
-
-
No concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor Xa inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted; please note that drugs that strongly induce or inhibit cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) or are associated with a risk of Torsades are not allowed; chronic concomitant treatment of CYP3A4 inducers is not allowed (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort); as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product; the following drugs are strong inhibitors of CYP3A4 and are not allowed during the treatment with cabozantinib:
- Boceprevir
- Indinavir
- Nelfinavir
- Lopinavir/ritonavir
- Saquinavir
- Telaprevir
- Ritonavir
- Clarithromycin
- Conivaptan
- Itraconazole
- Ketoconazole
- Mibefradil
- Nefazodone
- Posaconazole
- Voriconazole
- Telithromycin
- Drugs with possible or conditional risk of torsades should be used with caution knowing that cabozantinib could prolong the QT interval
-
Patients who are pregnant or nursing are not eligible; women of child bearing potential must have a negative serum or urine pregnancy test within 16 days prior to registration; women of child-bearing potential include:
- Any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12 consecutive months)
- Women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35m IU/mL
- Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy)
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, temozolomide and dacarbazine
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin =< 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5.0 × institutional upper limit of normal (for patients with metastases); AST (SGOT)/ALT (SGPT) =< 2.5 × institutional upper limit of normal (for patients without metastases)
- Serum creatinine =< 1.5 × ULN, OR calculated creatinine clearance >= 30 mL/minute (modified Cockcroft and Gault formula)
- Hemoglobin >= 9 g/dL
- Serum albumin >= 2.8 g/dL
- Urine protein/creatinine ratio (UPCR) =< 1; if urine/protein creatinine (UPC) >= 1, then a 24-hour urine protein must be assessed; eligible patients must have a 24-hour urine protein value < 1 g/L
- Thyroid-stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH however free T4 and free thyroxine index (FTI) are normal and patient is clinically euthyroid, patient is eligible
- Prothrombin time (PT)/international normalized ratio (INR) must be =< 1.2 x the laboratory ULN
- No clinical or radiographic evidence of pancreatitis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835145

United States, Alabama | |
University of Alabama at Birmingham Cancer Center | |
Birmingham, Alabama, United States, 35233 | |
United States, Alaska | |
Anchorage Radiation Therapy Center | |
Anchorage, Alaska, United States, 99504 | |
Alaska Breast Care and Surgery LLC | |
Anchorage, Alaska, United States, 99508 | |
Alaska Oncology and Hematology LLC | |
Anchorage, Alaska, United States, 99508 | |
Alaska Women's Cancer Care | |
Anchorage, Alaska, United States, 99508 | |
Anchorage Oncology Centre | |
Anchorage, Alaska, United States, 99508 | |
Katmai Oncology Group | |
Anchorage, Alaska, United States, 99508 | |
Providence Alaska Medical Center | |
Anchorage, Alaska, United States, 99508 | |
United States, California | |
Providence Saint Joseph Medical Center/Disney Family Cancer Center | |
Burbank, California, United States, 91505 | |
United States, Delaware | |
Beebe Medical Center | |
Lewes, Delaware, United States, 19958 | |
Christiana Gynecologic Oncology LLC | |
Newark, Delaware, United States, 19713 | |
Delaware Clinical and Laboratory Physicians PA | |
Newark, Delaware, United States, 19713 | |
Helen F Graham Cancer Center | |
Newark, Delaware, United States, 19713 | |
Medical Oncology Hematology Consultants PA | |
Newark, Delaware, United States, 19713 | |
Regional Hematology and Oncology PA | |
Newark, Delaware, United States, 19713 | |
Christiana Care Health System-Christiana Hospital | |
Newark, Delaware, United States, 19718 | |
Beebe Health Campus | |
Rehoboth Beach, Delaware, United States, 19971 | |
Nanticoke Memorial Hospital | |
Seaford, Delaware, United States, 19973 | |
Christiana Care Health System-Wilmington Hospital | |
Wilmington, Delaware, United States, 19801 | |
United States, Florida | |
Holy Cross Hospital | |
Fort Lauderdale, Florida, United States, 33308 | |
Jupiter Medical Center | |
Jupiter, Florida, United States, 33458 | |
Mount Sinai Medical Center | |
Miami Beach, Florida, United States, 33140 | |
United States, Idaho | |
Saint Luke's Mountain States Tumor Institute | |
Boise, Idaho, United States, 83712 | |
Kootenai Medical Center | |
Coeur d'Alene, Idaho, United States, 83814 | |
Saint Luke's Mountain States Tumor Institute - Fruitland | |
Fruitland, Idaho, United States, 83619 | |
Saint Luke's Mountain States Tumor Institute - Meridian | |
Meridian, Idaho, United States, 83642 | |
Saint Luke's Mountain States Tumor Institute - Nampa | |
Nampa, Idaho, United States, 83686 | |
Kootenai Cancer Center | |
Post Falls, Idaho, United States, 83854 | |
Kootenai Cancer Clinic | |
Sandpoint, Idaho, United States, 83864 | |
Saint Luke's Mountain States Tumor Institute-Twin Falls | |
Twin Falls, Idaho, United States, 83301 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
University of Chicago Comprehensive Cancer Center | |
Chicago, Illinois, United States, 60637 | |
Hematology Oncology Associates of Illinois-Highland Park | |
Highland Park, Illinois, United States, 60035 | |
Presence Saint Mary's Hospital | |
Kankakee, Illinois, United States, 60901 | |
NorthShore Hematology Oncology-Libertyville | |
Libertyville, Illinois, United States, 60048 | |
Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Garneau, Stewart C MD (UIA Investigator) | |
Moline, Illinois, United States, 61265 | |
Porubcin, Michael MD (UIA Investigator) | |
Moline, Illinois, United States, 61265 | |
Spector, David MD (UIA Investigator) | |
Moline, Illinois, United States, 61265 | |
Trinity Medical Center | |
Moline, Illinois, United States, 61265 | |
Good Samaritan Regional Health Center | |
Mount Vernon, Illinois, United States, 62864 | |
Illinois Cancer Specialists-Niles | |
Niles, Illinois, United States, 60714 | |
Hematology Oncology Associates of Illinois - Skokie | |
Skokie, Illinois, United States, 60076 | |
United States, Iowa | |
Mary Greeley Medical Center | |
Ames, Iowa, United States, 50010 | |
McFarland Clinic PC-William R Bliss Cancer Center | |
Ames, Iowa, United States, 50010 | |
Constantinou, Costas L MD (UIA Investigator) | |
Bettendorf, Iowa, United States, 52722 | |
McFarland Clinic PC-Boone | |
Boone, Iowa, United States, 50036 | |
McFarland Clinic PC-Trinity Cancer Center | |
Fort Dodge, Iowa, United States, 50501 | |
University of Iowa/Holden Comprehensive Cancer Center | |
Iowa City, Iowa, United States, 52242 | |
McFarland Clinic PC-Jefferson | |
Jefferson, Iowa, United States, 50129 | |
McFarland Clinic PC-Marshalltown | |
Marshalltown, Iowa, United States, 50158 | |
Siouxland Regional Cancer Center | |
Sioux City, Iowa, United States, 51101 | |
Mercy Medical Center-Sioux City | |
Sioux City, Iowa, United States, 51104 | |
Saint Luke's Regional Medical Center | |
Sioux City, Iowa, United States, 51104 | |
United States, Kansas | |
Menorah Medical Center | |
Overland Park, Kansas, United States, 66209 | |
Saint Luke's South Hospital | |
Overland Park, Kansas, United States, 66213 | |
Kansas City NCI Community Oncology Research Program | |
Prairie Village, Kansas, United States, 66208 | |
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Bronson Battle Creek | |
Battle Creek, Michigan, United States, 49017 | |
Green Bay Oncology - Escanaba | |
Escanaba, Michigan, United States, 49829 | |
Cancer Research Consortium of West Michigan NCORP | |
Grand Rapids, Michigan, United States, 49503 | |
Mercy Health Saint Mary's | |
Grand Rapids, Michigan, United States, 49503 | |
Spectrum Health at Butterworth Campus | |
Grand Rapids, Michigan, United States, 49503 | |
Green Bay Oncology - Iron Mountain | |
Iron Mountain, Michigan, United States, 49801 | |
Mercy Health Mercy Campus | |
Muskegon, Michigan, United States, 49444 | |
Lakeland Community Hospital | |
Niles, Michigan, United States, 49120 | |
Spectrum Health Reed City Hospital | |
Reed City, Michigan, United States, 49677 | |
Lakeland Hospital | |
Saint Joseph, Michigan, United States, 49085 | |
Marie Yeager Cancer Center | |
Saint Joseph, Michigan, United States, 49085 | |
Munson Medical Center | |
Traverse City, Michigan, United States, 49684 | |
United States, Minnesota | |
Fairview Ridges Hospital | |
Burnsville, Minnesota, United States, 55337 | |
Mercy Hospital | |
Coon Rapids, Minnesota, United States, 55433 | |
Essentia Health Cancer Center | |
Duluth, Minnesota, United States, 55805 | |
Essentia Health Saint Mary's Medical Center | |
Duluth, Minnesota, United States, 55805 | |
Miller-Dwan Hospital | |
Duluth, Minnesota, United States, 55805 | |
Fairview-Southdale Hospital | |
Edina, Minnesota, United States, 55435 | |
Unity Hospital | |
Fridley, Minnesota, United States, 55432 | |
Hutchinson Area Health Care | |
Hutchinson, Minnesota, United States, 55350 | |
Minnesota Oncology Hematology PA-Maplewood | |
Maplewood, Minnesota, United States, 55109 | |
Saint John's Hospital - Healtheast | |
Maplewood, Minnesota, United States, 55109 | |
Abbott-Northwestern Hospital | |
Minneapolis, Minnesota, United States, 55407 | |
Hennepin County Medical Center | |
Minneapolis, Minnesota, United States, 55415 | |
Health Partners Inc | |
Minneapolis, Minnesota, United States, 55454 | |
New Ulm Medical Center | |
New Ulm, Minnesota, United States, 56073 | |
North Memorial Medical Health Center | |
Robbinsdale, Minnesota, United States, 55422 | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
Metro Minnesota Community Oncology Research Consortium | |
Saint Louis Park, Minnesota, United States, 55416 | |
Park Nicollet Clinic - Saint Louis Park | |
Saint Louis Park, Minnesota, United States, 55416 | |
Regions Hospital | |
Saint Paul, Minnesota, United States, 55101 | |
United Hospital | |
Saint Paul, Minnesota, United States, 55102 | |
Saint Francis Regional Medical Center | |
Shakopee, Minnesota, United States, 55379 | |
Lakeview Hospital | |
Stillwater, Minnesota, United States, 55082 | |
Ridgeview Medical Center | |
Waconia, Minnesota, United States, 55387 | |
Rice Memorial Hospital | |
Willmar, Minnesota, United States, 56201 | |
Minnesota Oncology Hematology PA-Woodbury | |
Woodbury, Minnesota, United States, 55125 | |
United States, Missouri | |
Cox Cancer Center Branson | |
Branson, Missouri, United States, 65616 | |
Centerpoint Medical Center LLC | |
Independence, Missouri, United States, 64057 | |
Mercy Hospital Joplin | |
Joplin, Missouri, United States, 64804 | |
Saint Luke's Hospital of Kansas City | |
Kansas City, Missouri, United States, 64111 | |
Heartland Hematology and Oncology Associates Incorporated | |
Kansas City, Missouri, United States, 64118 | |
Research Medical Center | |
Kansas City, Missouri, United States, 64132 | |
Saint Luke's East - Lee's Summit | |
Lee's Summit, Missouri, United States, 64086 | |
Liberty Radiation Oncology Center | |
Liberty, Missouri, United States, 64068 | |
Mercy Clinic-Rolla-Cancer and Hematology | |
Rolla, Missouri, United States, 65401 | |
Heartland Regional Medical Center | |
Saint Joseph, Missouri, United States, 64507 | |
Saint Joseph Oncology Inc | |
Saint Joseph, Missouri, United States, 64507 | |
Saint Louis Cancer and Breast Institute-South City | |
Saint Louis, Missouri, United States, 63109 | |
Mercy Hospital Saint Louis | |
Saint Louis, Missouri, United States, 63141 | |
Cancer Research for the Ozarks NCORP | |
Springfield, Missouri, United States, 65804 | |
Mercy Hospital Springfield | |
Springfield, Missouri, United States, 65804 | |
CoxHealth South Hospital | |
Springfield, Missouri, United States, 65807 | |
United States, Montana | |
Community Hospital of Anaconda | |
Anaconda, Montana, United States, 59711 | |
Billings Clinic Cancer Center | |
Billings, Montana, United States, 59101 | |
Saint Vincent Healthcare | |
Billings, Montana, United States, 59101 | |
Montana Cancer Consortium NCORP | |
Billings, Montana, United States, 59102 | |
Bozeman Deaconess Hospital | |
Bozeman, Montana, United States, 59715 | |
Saint James Community Hospital and Cancer Treatment Center | |
Butte, Montana, United States, 59701 | |
Benefis Healthcare- Sletten Cancer Institute | |
Great Falls, Montana, United States, 59405 | |
Great Falls Clinic | |
Great Falls, Montana, United States, 59405 | |
Saint Peter's Community Hospital | |
Helena, Montana, United States, 59601 | |
Kalispell Regional Medical Center | |
Kalispell, Montana, United States, 59901 | |
Saint Patrick Hospital - Community Hospital | |
Missoula, Montana, United States, 59802 | |
Community Medical Hospital | |
Missoula, Montana, United States, 59804 | |
United States, Nebraska | |
Nebraska Methodist Hospital | |
Omaha, Nebraska, United States, 68114 | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 | |
United States, Nevada | |
Cancer and Blood Specialists-Henderson | |
Henderson, Nevada, United States, 89052 | |
Comprehensive Cancer Centers of Nevada - Henderson | |
Henderson, Nevada, United States, 89052 | |
Las Vegas Cancer Center-Henderson | |
Henderson, Nevada, United States, 89052 | |
21st Century Oncology-Henderson | |
Henderson, Nevada, United States, 89074 | |
Comprehensive Cancer Centers of Nevada-Southeast Henderson | |
Henderson, Nevada, United States, 89074 | |
University Medical Center of Southern Nevada | |
Las Vegas, Nevada, United States, 89102 | |
Cancer and Blood Specialists-Shadow | |
Las Vegas, Nevada, United States, 89106 | |
Nevada Cancer Research Foundation CCOP | |
Las Vegas, Nevada, United States, 89106 | |
Radiation Oncology Centers of Nevada Central | |
Las Vegas, Nevada, United States, 89106 | |
21st Century Oncology | |
Las Vegas, Nevada, United States, 89109 | |
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway | |
Las Vegas, Nevada, United States, 89109 | |
HealthCare Partners Medical Group Oncology/Hematology-San Martin | |
Las Vegas, Nevada, United States, 89113 | |
Radiation Oncology Centers of Nevada Southeast | |
Las Vegas, Nevada, United States, 89119 | |
Cancer Therapy and Integrative Medicine | |
Las Vegas, Nevada, United States, 89121 | |
21st Century Oncology-Vegas Tenaya | |
Las Vegas, Nevada, United States, 89128 | |
Cancer and Blood Specialists-Tenaya | |
Las Vegas, Nevada, United States, 89128 | |
Comprehensive Cancer Centers of Nevada - Northwest | |
Las Vegas, Nevada, United States, 89128 | |
HealthCare Partners Medical Group Oncology/Hematology-Tenaya | |
Las Vegas, Nevada, United States, 89128 | |
Comprehensive Cancer Centers of Nevada-Summerlin | |
Las Vegas, Nevada, United States, 89144 | |
Las Vegas Cancer Center-Medical Center | |
Las Vegas, Nevada, United States, 89148-2405 | |
21st Century Oncology-Fort Apache | |
Las Vegas, Nevada, United States, 89148 | |
Comprehensive Cancer Centers of Nevada | |
Las Vegas, Nevada, United States, 89148 | |
Nevada Cancer Specialists-Fort Apache | |
Las Vegas, Nevada, United States, 89148 | |
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills | |
Las Vegas, Nevada, United States, 89149 | |
Comprehensive Cancer Centers of Nevada - Central Valley | |
Las Vegas, Nevada, United States, 89169 | |
United States, New Jersey | |
Morristown Medical Center | |
Morristown, New Jersey, United States, 07960 | |
Overlook Hospital | |
Summit, New Jersey, United States, 07902 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
Kinston Medical Specialists PA | |
Kinston, North Carolina, United States, 28501 | |
Wake Forest University Health Sciences | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Ohio | |
The Christ Hospital | |
Cincinnati, Ohio, United States, 45219 | |
Ohio State University Comprehensive Cancer Center | |
Columbus, Ohio, United States, 43210 | |
United States, Oklahoma | |
University of Oklahoma Health Sciences Center | |
Oklahoma City, Oklahoma, United States, 73104 | |
Oklahoma Cancer Specialists and Research Institute-Tulsa | |
Tulsa, Oklahoma, United States, 74146 | |
United States, Oregon | |
Saint Charles Health System | |
Bend, Oregon, United States, 97701 | |
Clackamas Radiation Oncology Center | |
Clackamas, Oregon, United States, 97015 | |
Providence Oncology and Hematology Care Southeast | |
Clackamas, Oregon, United States, 97015 | |
Bay Area Hospital | |
Coos Bay, Oregon, United States, 97420 | |
Providence Milwaukie Hospital | |
Milwaukie, Oregon, United States, 97222 | |
Providence Newberg Medical Center | |
Newberg, Oregon, United States, 97132 | |
Providence Willamette Falls Medical Center | |
Oregon City, Oregon, United States, 97045 | |
Providence Portland Medical Center | |
Portland, Oregon, United States, 97213 | |
Providence Saint Vincent Medical Center | |
Portland, Oregon, United States, 97225 | |
United States, Pennsylvania | |
University of Pennsylvania/Abramson Cancer Center | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
Greenville Health System Cancer Institute-Easley | |
Easley, South Carolina, United States, 29640 | |
Greenville Health System Cancer Institute-Andrews | |
Greenville, South Carolina, United States, 29601 | |
Greenville Health System Cancer Institute-Butternut | |
Greenville, South Carolina, United States, 29605 | |
Greenville Health System Cancer Institute-Faris | |
Greenville, South Carolina, United States, 29605 | |
Greenville Memorial Hospital | |
Greenville, South Carolina, United States, 29605 | |
Greenville Health System Cancer Institute-Eastside | |
Greenville, South Carolina, United States, 29615 | |
Greenville Health System Cancer Institute-Greer | |
Greer, South Carolina, United States, 29650 | |
Greenville Health System Cancer Institute-Seneca | |
Seneca, South Carolina, United States, 29672 | |
Greenville Health System Cancer Institute-Spartanburg | |
Spartanburg, South Carolina, United States, 29307 | |
United States, Tennessee | |
Wellmont Bristol Regional Medical Center | |
Bristol, Tennessee, United States, 37620 | |
Wellmont Medical Associates Oncology and Hematology-Johnson City | |
Johnson City, Tennessee, United States, 37604 | |
Wellmont Holston Valley Hospital and Medical Center | |
Kingsport, Tennessee, United States, 37660 | |
Wellmont Medical Associates Oncology and Hematology-Kingsport | |
Kingsport, Tennessee, United States, 37660 | |
United States, Texas | |
UT Southwestern/Simmons Cancer Center-Dallas | |
Dallas, Texas, United States, 75390 | |
United States, Virginia | |
Southwest VA Regional Cancer Center | |
Norton, Virginia, United States, 24273 | |
United States, Washington | |
Providence Regional Cancer System-Aberdeen | |
Aberdeen, Washington, United States, 98520 | |
Cancer Care Center at Island Hospital | |
Anacortes, Washington, United States, 98221 | |
Swedish Cancer Institute-Eastside Oncology Hematology | |
Bellevue, Washington, United States, 98005 | |
PeaceHealth Saint Joseph Medical Center | |
Bellingham, Washington, United States, 98225 | |
Providence Regional Cancer System-Centralia | |
Centralia, Washington, United States, 98531 | |
Swedish Medical Center-Edmonds | |
Edmonds, Washington, United States, 98026 | |
Providence Regional Cancer Partnership | |
Everett, Washington, United States, 98201 | |
Swedish Cancer Institute-Issaquah | |
Issaquah, Washington, United States, 98029 | |
Providence Regional Cancer System-Lacey | |
Lacey, Washington, United States, 98503 | |
PeaceHealth Saint John Medical Center | |
Longview, Washington, United States, 98632 | |
Minor and James Medical PLLC | |
Seattle, Washington, United States, 98104 | |
Pacific Gynecology Specialists | |
Seattle, Washington, United States, 98104 | |
Swedish Medical Center-Ballard Campus | |
Seattle, Washington, United States, 98107 | |
Kaiser Permanente Washington | |
Seattle, Washington, United States, 98112 | |
Swedish Medical Center-First Hill | |
Seattle, Washington, United States, 98122-4307 | |
Providence Regional Cancer System-Shelton | |
Shelton, Washington, United States, 98584 | |
Rockwood Clinic Cancer Treatment Center-Valley | |
Spokane Valley, Washington, United States, 99216 | |
Rockwood Cancer Treatment Center-DHEC-Downtown | |
Spokane, Washington, United States, 99204 | |
PeaceHealth Southwest Medical Center | |
Vancouver, Washington, United States, 98664 | |
Compass Oncology Vancouver | |
Vancouver, Washington, United States, 98684 | |
Providence Saint Mary Regional Cancer Center | |
Walla Walla, Washington, United States, 99362 | |
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | |
Yakima, Washington, United States, 98902 | |
Providence Regional Cancer System-Yelm | |
Yelm, Washington, United States, 98597 | |
United States, Wisconsin | |
Green Bay Oncology at Saint Vincent Hospital | |
Green Bay, Wisconsin, United States, 54301-3526 | |
Saint Vincent Hospital Cancer Center Green Bay | |
Green Bay, Wisconsin, United States, 54301 | |
Green Bay Oncology Limited at Saint Mary's Hospital | |
Green Bay, Wisconsin, United States, 54303 | |
Saint Vincent Hospital Cancer Center at Saint Mary's | |
Green Bay, Wisconsin, United States, 54303 | |
University of Wisconsin Hospital and Clinics | |
Madison, Wisconsin, United States, 53792 | |
Holy Family Memorial Hospital | |
Manitowoc, Wisconsin, United States, 54221 | |
Bay Area Medical Center | |
Marinette, Wisconsin, United States, 54143 | |
Froedtert and the Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 | |
Cancer Center of Western Wisconsin | |
New Richmond, Wisconsin, United States, 54017 | |
Green Bay Oncology - Oconto Falls | |
Oconto Falls, Wisconsin, United States, 54154 | |
HSHS Saint Nicholas Hospital | |
Sheboygan, Wisconsin, United States, 53081 | |
Green Bay Oncology - Sturgeon Bay | |
Sturgeon Bay, Wisconsin, United States, 54235 | |
United States, Wyoming | |
Rocky Mountain Oncology | |
Casper, Wyoming, United States, 82609 | |
Big Horn Basin Cancer Center | |
Cody, Wyoming, United States, 82414 | |
Billings Clinic-Cody | |
Cody, Wyoming, United States, 82414 | |
Welch Cancer Center | |
Sheridan, Wyoming, United States, 82801 | |
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, Ontario | |
University Health Network-Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
CHUM - Hopital Notre-Dame | |
Montreal, Quebec, Canada, H2L 4M1 | |
Canada, Saskatchewan | |
Saskatoon Cancer Centre | |
Saskatoon, Saskatchewan, Canada, S7N 4H4 |
Principal Investigator: | Jason Luke | Alliance for Clinical Trials in Oncology |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT01835145 History of Changes |
Other Study ID Numbers: |
NCI-2013-00821 NCI-2013-00821 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CALGB-A091201 A091201 A091201 ( Other Identifier: Alliance for Clinical Trials in Oncology ) A091201 ( Other Identifier: CTEP ) U10CA180821 ( U.S. NIH Grant/Contract ) U10CA031946 ( U.S. NIH Grant/Contract ) |
First Posted: | April 18, 2013 Key Record Dates |
Last Update Posted: | February 28, 2018 |
Last Verified: | February 2018 |
Additional relevant MeSH terms:
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site |
Eye Diseases Uveal Diseases Temozolomide Dacarbazine Imidazole Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |