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Spots Global Cancer Trial Database for Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary

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Trial Identification

Brief Title: Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary

Official Title: A Phase II Study of Carboplatin (CBDCA), Paclitaxel (TAXOL), and Everolimus (RAD001) in Previously Untreated Patients With Measurable Disease With Cancer of Unknown Primary (CUP)

Study ID: NCT00936702

Study Description

Brief Summary: RATIONALE: 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. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well carboplatin given together with paclitaxel and everolimus works in treating patients with previously untreated cancer of unknown primary.

Detailed Description: OBJECTIVES: Primary * Evaluate the response rate in patients with previously untreated cancer of unknown primary treated with the combination of carboplatin, paclitaxel, and everolimus. Secondary * Assess time to progression, overall survival, duration of response, and time to treatment failure in patients treated with this regimen. * Determine adverse events of this regimen in these patients. * Perform descriptive correlative studies to determine response of specific tumor types, identified by the Origin-FFPE test, to this regimen. OUTLINE: This is a multicenter study. Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive oral everolimus once daily on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients' tumor tissue samples from the most recent biopsy are analyzed for correlative studies, including gene expression profiling by Origin-FFPE test. After completion of study therapy, patients are followed up every 3 months until disease progression, and then every 6 months for up to 3 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Poudre Valley Hospital, Fort Collins, Colorado, United States

Front Range Cancer Specialists, Fort Collins, Colorado, United States

Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States

, Moline, Illinois, United States

Elkhart Clinic, LLC, Elkhart, Indiana, United States

Michiana Hematology-Oncology, PC - Elkhart, Elkhart, Indiana, United States

Elkhart General Hospital, Elkhart, Indiana, United States

St. Francis Hospital Cancer Care Services, Indianapolis, Indiana, United States

Howard Community Hospital, Kokomo, Indiana, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States

Michiana Hematology-Oncology, PC - South Bend, Mishawaka, Indiana, United States

Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States

Michiana Hematology Oncology PC - Plymouth, Plymouth, Indiana, United States

Reid Hospital & Health Care Services, Richmond, Indiana, United States

CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States

Memorial Hospital of South Bend, South Bend, Indiana, United States

Michiana Hematology Oncology PC - La Porte, Westville, Indiana, United States

McFarland Clinic, PC, Ames, Iowa, United States

, Bettendorf, Iowa, United States

Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States

Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States

Medical Oncology and Hematology Associates - West Des Moines, Clive, Iowa, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States

Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States

McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, United States

Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States

Mercy Medical Center - Sioux City, Sioux City, Iowa, United States

St. Luke's Regional Medical Center, Sioux City, Iowa, United States

Cancer Center of Kansas, PA - Chanute, Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City, Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado, El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States

Cancer Center of Kansas-Independence, Independence, Kansas, United States

Cancer Center of Kansas, PA - Kingman, Kingman, Kansas, United States

Lawrence Memorial Hospital, Lawrence, Kansas, United States

Cancer Center of Kansas, PA - Liberal, Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton, Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons, Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt, Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina, Salina, Kansas, United States

Cancer Center of Kansas, PA - Wellington, Wellington, Kansas, United States

Associates in Womens Health, PA - North Review, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wichita, Wichita, Kansas, United States

CCOP - Wichita, Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield, Winfield, Kansas, United States

Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States

Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States

Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States

Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States

Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States

CCOP - Grand Rapids, Grand Rapids, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States

Dickinson County Healthcare System, Iron Mountain, Michigan, United States

Foote Memorial Hospital, Jackson, Michigan, United States

Sparrow Regional Cancer Center, Lansing, Michigan, United States

St. Mary Mercy Hospital, Livonia, Michigan, United States

Community Cancer Center of Monroe, Monroe, Michigan, United States

Mercy Memorial Hospital - Monroe, Monroe, Michigan, United States

Mercy General Health Partners, Muskegon, Michigan, United States

St. Joseph Mercy Oakland, Pontiac, Michigan, United States

Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States

Spectrum Health Reed City Hospital, Reed City, Michigan, United States

Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States

Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph, Michigan, United States

Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States

Munson Medical Center, Traverse City, Michigan, United States

St. John Macomb Hospital, Warren, Michigan, United States

MeritCare Bemidji, Bemidji, Minnesota, United States

Essentia Health - Duluth Clinic, Duluth, Minnesota, United States

CCOP - Duluth, Duluth, Minnesota, United States

Miller - Dwan Medical Center, Duluth, Minnesota, United States

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States

St. John's Regional Health Center, Springfield, Missouri, United States

Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, United States

CCOP - Montana Cancer Consortium, Billings, Montana, United States

St. Vincent Healthcare Cancer Care Services, Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States

Billings Clinic - Downtown, Billings, Montana, United States

Bozeman Deaconess Cancer Center, Bozeman, Montana, United States

St. James Healthcare Cancer Care, Butte, Montana, United States

Sletten Cancer Institute at Benefis Healthcare, Great Falls, Montana, United States

St. Peter's Hospital, Helena, Montana, United States

Kalispell Regional Medical Center, Kalispell, Montana, United States

Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States

Medcenter One Hospital Cancer Care Center, Bismarck, North Dakota, United States

Mid Dakota Clinic, PC, Bismarck, North Dakota, United States

St. Alexius Medical Center Cancer Center, Bismarck, North Dakota, United States

MeritCare Broadway, Fargo, North Dakota, United States

CCOP - MeritCare Hospital, Fargo, North Dakota, United States

Wood County Oncology Center, Bowling Green, Ohio, United States

Grandview Hospital, Dayton, Ohio, United States

Good Samaritan Hospital, Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States

Samaritan North Cancer Care Center, Dayton, Ohio, United States

CCOP - Dayton, Dayton, Ohio, United States

Community Cancer Center, Elyria, Ohio, United States

Hematology Oncology Center, Elyria, Ohio, United States

Blanchard Valley Medical Associates, Findlay, Ohio, United States

Middletown Regional Hospital, Franklin, Ohio, United States

Wayne Hospital, Greenville, Ohio, United States

Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States

Lima Memorial Hospital, Lima, Ohio, United States

Northwest Ohio Oncology Center, Maumee, Ohio, United States

St. Charles Mercy Hospital, Oregon, Ohio, United States

Toledo Clinic - Oregon, Oregon, Ohio, United States

Flower Hospital Cancer Center, Sylvania, Ohio, United States

Mercy Hospital of Tiffin, Tiffin, Ohio, United States

Toledo Hospital, Toledo, Ohio, United States

St. Vincent Mercy Medical Center, Toledo, Ohio, United States

Medical University of Ohio Cancer Center, Toledo, Ohio, United States

CCOP - Toledo Community Hospital, Toledo, Ohio, United States

St. Anne Mercy Hospital, Toledo, Ohio, United States

Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio, United States

UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States

Fulton County Health Center, Wauseon, Ohio, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States

Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States

Fredericksburg Oncology, Incorporated, Fredericksburg, Virginia, United States

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States

St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States

St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States

Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States

St. Nicholas Hospital, Sheboygan, Wisconsin, United States

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States

Contact Details

Name: Matthew P. Goetz, MD

Affiliation: Mayo Clinic

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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