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CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical research trials and CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer. CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer  CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer
CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer
For Condition: extensive stage small cell lung cancer
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of different doses of CCI-779 in treating patients who have extensive-stage small cell lung cancer.
Details: OBJECTIVES: - Determine the progression-free survival of patients with extensive-stage small cell lung cancer treated with CCI-779. - Determine the toxicity of this drug in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to brain metastases (yes vs no), prior induction chemotherapy regimen (platinum and etoposide vs platinum and irinotecan), and response to prior induction chemotherapy (complete or partial response vs stable disease). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive low-dose CCI-779 IV over 30 minutes once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive high-dose CCI-779 as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study within 2.7-3.2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed small cell lung cancer - Extensive disease - Responsive or stable disease after prior induction chemotherapy comprising cisplatin or carboplatin AND etoposide or irinotecan - No untreated, symptomatic brain metastases that require concurrent corticosteroids PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - Cholesterol less than 350 mg/dL - Triglycerides less than 400 mg/dL Renal: - Creatinine no greater than 1.5 mg/dL Other: - No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No prior allergic reactions attributed to compounds of similar chemical or biological composition to CCI-779 or to any of the components of its formulation - No allergy or contraindications to antihistamines - Not immunocompromised - No active or serious concurrent infection - Not pregnant or nursing - Fertile patients must use effective contraception during and for at least 12 weeks after study PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biological response modifiers Chemotherapy: - See Disease Characteristics - No less than 3 and no more than 6 prior courses of induction chemotherapy - At least 4 and no more than 8 weeks since prior induction chemotherapy and recovered - No more than 32 weeks since first dose of induction chemotherapy for metastatic disease Endocrine therapy: - See Disease Characteristics Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to target lesions Surgery: - Not specified Other: - At least 3 weeks since prior immunosuppressive therapy - No concurrent anticonvulsant therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KishanPandya, Study Chair, James P. Wilmot Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-1000
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611-4494
United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, 10466
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07019
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
CCOP - Evanston
Evanston, Illinois, 60201
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Tufts - New England Medical Center
Boston, Massachusetts, 02111
United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80224
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6307
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
Additional Information:
Study ID Numbers: CDR0000069118; ECOG-E1500
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028028
Other Extensive Stage Small Cell Lung Cancer Studies:
1. Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer
2. Combination Chemotherapy With or Without Oblimersen in Treating Patients With Extensive-Stage Small Cell Lung Cancer
3. Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer
4. Bortezomib in Treating Patients With Recurrent or Refractory Extensive-Stage Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
5. CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Related Studies:
Other extensive stage small cell lung cancer Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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