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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00079235 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. CCI-779 may also stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well CCI-779 works in treating patients with stage IIIB non small cell lung cancer (with pleural effusion) or stage IV non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: temsirolimus |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients With Advanced Non-Small Cell Lung Cancer |
| Estimated Enrollment: | 55 |
| Study Start Date: | February 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 25-55 patients will be accrued for this study within 12 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
Measurable disease
The following are not considered measurable disease:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolula, Hawaii, United States, 96813 | |
| Kapiolani Medical Center at Pali Momi | |
| Aiea, Hawaii, United States, 96701 | |
| Kapiolani Medical Center for Women and Children | |
| Honolulu, Hawaii, United States, 96826 | |
| Leeward Radiation Oncology Center | |
| Ewa Beach, Hawaii, United States, 96706 | |
| Straub Clinic and Hospital, Incorporated | |
| Honolulu, Hawaii, United States, 96813 | |
| OnCare Hawaii, Incorporated - Lusitana | |
| Honolulu, Hawaii, United States, 96813 | |
| Pacific Cancer Institute - Maui | |
| Wailuku, Maui, Hawaii, United States, 96793 | |
| Queen's Cancer Institute at Queen's Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| St. Francis Medical Center | |
| Honolulu, Hawaii, United States, 96817 | |
| OnCare Hawaii, Incorporated - Kuakini | |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Illinois | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| Carle Cancer Center at Carle Foundation Hospital | |
| Urbana, Illinois, United States, 61801 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Galesburg Clinic | |
| Galesburg, Illinois, United States, 61401 | |
| Galesburg Cottage Hospital | |
| Galesburg, Illinois, United States, 61401 | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Hopedale Medical Complex | |
| Hopedale, Illinois, United States, 61747 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Joliet Oncology-Hematology Associates, Limited - West | |
| Joliet, Illinois, United States, 60435 | |
| Kewanee Hospital | |
| Kewanee, Illinois, United States, 61443 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| Rush-Copley Cancer Care Center | |
| Aurora, Illinois, United States, 60507 | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| St. Margaret's Hospital | |
| Spring Valley, Illinois, United States, 61362 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| Howard Community Hospital at Howard Regional Health System | |
| Kokomo, Indiana, United States, 46904 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| Reid Hospital & Health Care Services, Incorporated | |
| Richmond, Indiana, United States, 47374 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| Saint Joseph Regional Medical Center | |
| South Bend, Indiana, United States, 46617 | |
| St. Francis Hospital and Health Centers - Beech Grove Campus | |
| Beech Grove, Indiana, United States, 46107 | |
| United States, Iowa | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Mercy Regional Cancer Center at Mercy Medical Center | |
| Cedar Rapids, Iowa, United States, 52403 | |
| St. Luke's Hospital | |
| Cedar Rapids, Iowa, United States, 52402 | |
| United States, Kansas | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67203 | |
| Cancer Center of Kansas, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas, PA - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, PA - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, PA - Salina | |
| Salina, Kansas, United States, 67042 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Southwest Medical Center | |
| Liberal, Kansas, United States, 67901 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| United States, Michigan | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Foote Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Green Bay Oncology, Limited - Escanaba | |
| Escanaba, Michigan, United States, 49431 | |
| Green Bay Oncology, Limited - Iron Mountain | |
| Iron Mountain, Michigan, United States, 49801 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
| St. Joseph, Michigan, United States, 49085 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| Seton Cancer Institute - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48909 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123-2500 | |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| United States, Minnesota | |
| Adult and Pediatric Urology, P.L.L.P. | |
| Sartell, Minnesota, United States, 56377 | |
| Brainerd Medical Center | |
| Brainerd, Minnesota, United States, 56401 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| Chippewa County - Montevideo Hospital | |
| Montevideo, Minnesota, United States, 56265 | |
| Coborn Cancer Center | |
| Saint Cloud, Minnesota, United States, 56303 | |
| CentraCare Clinic - River Campus | |
| St. Cloud, Minnesota, United States, 56303 | |
| MeritCare Clinic - Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| St. Joseph's Medical Center | |
| Brainerd, Minnesota, United States, 56401 | |
| Fergus Falls, Minnesota, United States, 56537 | |
| Alexandria, Minnesota, United States, 56308 | |
| United States, Montana | |
| Bozeman Deaconess Hospital | |
| Bozeman, Montana, United States, 59715 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Clinic of Dr. Judy L. Schmidt | |
| Missoula, Montana, United States, 59804 | |
| Community Medical Center | |
| Missoula, Montana, United States, 59801 | |
| Deaconess Billings Clinic - Downtown | |
| Billings, Montana, United States, 59107-7000 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| Kalispell Medical Oncology | |
| Kalispell, Montana, United States, 59901 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59807 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59807-7877 | |
| Northern Rockies Radiation Oncology Center | |
| Billings, Montana, United States, 59101 | |
| St. James Community Hospital | |
| Butte, Montana, United States, 59701 | |
| Glacier Oncology, PLLC | |
| Kalispell, Montana, United States, 59901 | |
| St. Vincent Healthcare | |
| Billings, Montana, United States, 59101 | |
| United States, Nebraska | |
| Cancer Resource Center - Lincoln | |
| Lincoln, Nebraska, United States, 68510 | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| United States, North Carolina | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| United States, North Dakota | |
| Bismarck Cancer Center | |
| Bismarck, North Dakota, United States, 58501 | |
| Mid Dakota Clinic, P. C. | |
| Bismarck, North Dakota, United States, 58501 | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| MeritCare Medical Group | |
| Fargo, North Dakota, United States, 58122 | |
| Cancer Care Center at Medcenter One Hospital | |
| Bismarck, North Dakota, United States, 58501 | |
| St. Alexius Medical Center | |
| Bismarck, North Dakota, United States, 58502 | |
| United States, Ohio | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| Middletown Regional Hospital | |
| Middletown, Ohio, United States, 45044 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| Veterans Affairs Medical Center - Dayton | |
| Dayton, Ohio, United States, 45428 | |
| United States, South Carolina | |
| AnMed Health Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sioux Valley Hospital and University of South Dakota Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Wisconsin | |
| Bay Area Cancer Care Center at Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| Green Bay Oncology, Limited - Oconto Falls | |
| Oconto Falls, Wisconsin, United States, 54154 | |
| Green Bay Oncology, Limited - Sturgeon Bay | |
| Sturgeon Bay, Wisconsin, United States, 54235 | |
| Green Bay Oncology, Limited at St. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Vincent Hospital | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| St. Mary's Hospital Medical Center - Green Bay | |
| Green Bay, Wisconsin, United States, 54303 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| United States, Wyoming | |
| Welch Cancer Center at Sheridan Memorial Hospital | |
| Sheridan, Wyoming, United States, 82801 | |
| Study Chair: | Alex A. Adjei, MD, PhD | Mayo Clinic |
| Investigator: | Donald W. Northfelt, MD, FACP | Mayo Clinic Scottsdale |
| Investigator: | Jann N. Sarkaria, MD | Mayo Clinic |
More Information
| Study ID Numbers: | CDR0000355117, NCCTG-N0323 |
| Study First Received: | March 8, 2004 |
| Last Updated: | November 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00079235 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |