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

Study Description

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Brief Summary:

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.

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

Detailed Description:

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 Design

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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

Arms and Interventions

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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: BMS-907351; Cabometyx; Cometriq; XL184 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: 4-(Dimethyltriazeno)imidazole-5-carboxamide; 5-(Dimethyltriazeno)imidazole-4-carboxamide; Asercit; Biocarbazine; Dacarbazina; Dacarbazina Almirall; Dacarbazine - DTIC; Dacatic; Dakarbazin; Deticene; Detimedac; DIC; Dimethyl (triazeno) imidazolecarboxamide; Dimethyl Triazeno Imidazol Carboxamide; Dimethyl Triazeno Imidazole Carboxamide; dimethyl-triazeno-imidazole carboxamide; Dimethyl-triazeno-imidazole-carboximide; DTIC; DTIC-Dome; Fauldetic; Imidazole Carboxamide; Imidazole Carboxamide Dimethyltriazeno; WR-139007 Other: Laboratory Biomarker Analysis; Correlative studies Drug: Temozolomide; Given PO; Other Names: CCRG-81045; Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-; M & B 39831; M and B 39831; Methazolastone; RP-46161; SCH 52365; Temcad; Temodal; Temodar; Temomedac

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Other Outcome Measures:

1. 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.
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Locations

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

Sponsors and Collaborators

National Cancer Institute (NCI)

Exelisis

Investigators

Principal Investigator:	Jason Luke	Alliance for Clinical Trials in Oncology

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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