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	Treatment or Intervention	Phase
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer	Drug: CCI-779  Procedure: chemotherapy  Procedure: enzyme inhibitor therapy	Phase II

Further Study Details: 

OBJECTIVES: Primary

• Determine the response rate in patients with stage IIIB (with pleural effusion) or IV non-small cell lung cancer treated with CCI-779.
• Determine the clinical toxic effects of this drug in these patients.

Secondary

• Determine the 24-week progression-free survival rate in patients treated with this drug.
• Determine the time to progression and overall survival of patients treated with this drug.
• Evaluate predictive markers of activity (e.g., PTEN mutations and phosphoAkt expression) of this drug in these patients.

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
• Stage IIIB (with pleural effusion) or IV disease
• Measurable disease
• At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
• The following are not considered measurable disease:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Inflammatory breast disease
• Lymphangitis cutis/pulmonis
• Cystic lesions
• Abdominal masses that are not confirmed and followed by imaging techniques
• Blood and tissue blocks available
• No known brain metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10 g/dL

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• AST ≤ 3 times ULN (5 times ULN if hepatic metastases are present)

Renal

• Creatinine ≤ 1.5 times ULN

Other

• Serum fasting cholesterol ≤ 350 mg/dL
• Serum fasting triglycerides ≤ 400 mg/dL
• HIV negative
• No uncontrolled infection
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or non-invasive carcinomas
• No concurrent severe underlying disease that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study treatment

PRIOR CONCURRENT THERAPY: Biologic therapy

• No prior biologic therapy
• No prior gene therapy
• No prior immunotherapy
• No concurrent immunotherapy
• No concurrent prophylactic growth factors to support neutrophil count

Chemotherapy

• No prior chemotherapy for NSCLC except low-dose cisplatin as a radiosensitizer
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent dexamethasone (10 mg IV)

Radiotherapy

• No prior radiotherapy to 30% or more of bone marrow
• Concurrent radiotherapy for underlying malignancy and non-target sites (e.g., painful pre-existing bony metastasis) allowed

Surgery

• Not specified

Other

• No other concurrent investigational therapy
• No concurrent immunosuppressive therapy

Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
Colorado
      Front Range Cancer Specialists, Fort Collins,  Colorado,  80524-4038,  United States; Recruiting
Hawaii
      Kapiolani Medical Center at Pali Momi, Aiea,  Hawaii,  96701,  United States; Recruiting
      Kapiolani Medical Center for Women and Children, Honolulu,  Hawaii,  96826,  United States; Recruiting
      OnCare Hawaii, Incorporated - Kuakini, Honolulu,  Hawaii,  96817,  United States; Recruiting
      OnCare Hawaii, Incorporated - Lusitana, Honolulu,  Hawaii,  96813,  United States; Recruiting
      Queen's Cancer Institute at Queen's Medical Center, Honolulu,  Hawaii,  96813,  United States; Recruiting
      St. Francis Medical Center, Honolulu,  Hawaii,  96817,  United States; Recruiting
      Straub Clinic and Hospital, Incorporated, Honolulu,  Hawaii,  96813,  United States; Recruiting
      University of Hawaii John A. Burns School of Medicine, Honolulu,  Hawaii,  96822,  United States; Recruiting
Illinois
      BroMenn Regional Medical Center, Normal,  Illinois,  61761,  United States; Recruiting
      Cancer Treatment Center at Pekin Hospital, Pekin,  Illinois,  61554,  United States; Recruiting
      Carle Clinic Association, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      Community Cancer Center, Normal,  Illinois,  61761,  United States; Recruiting
      Community Hospital of Ottawa, Ottawa,  Illinois,  61350,  United States; Recruiting
      Eureka Hospital, Eureka,  Illinois,  61530,  United States; Recruiting
      Galesburg Clinic, Galesburg,  Illinois,  61401,  United States; Recruiting
      Rush-Copley Cancer Care Center, Aurora,  Illinois,  60504-4206,  United States; Recruiting
      Galesburg Cottage Hospital, Galesburg,  Illinois,  61401,  United States; Recruiting
      Graham Hospital, Canton,  Illinois,  61520,  United States; Recruiting
      Hopedale Medical Complex, Hopedale,  Illinois,  61747,  United States; Recruiting
      Illinois Valley Community Hospital, Peru,  Illinois,  61354,  United States; Recruiting
      InterCommunity Cancer Center of Western Illinois, Galesburg,  Illinois,  61401,  United States; Recruiting
      Joliet Oncology Hematology Associates, Limited - West, Joliet,  Illinois,  60435,  United States; Recruiting
      Kewanee Hospital, Kewanee,  Illinois,  61443,  United States; Recruiting
      Mason District Hospital, Havana,  Illinois,  62644,  United States; Recruiting
      McDonough District Hospital, Macomb,  Illinois,  61455,  United States; Recruiting
      Memorial Hospital, Carthage,  Illinois,  62321,  United States; Recruiting
      Methodist Medical Center of Illinois, Peoria,  Illinois,  61636,  United States; Recruiting
      OSF St. Francis Medical Center, Peoria,  Illinois,  61637,  United States; Recruiting
      Oncology/Hematology Associates of Central Illinois, P.C., Peoria,  Illinois,  61615-7828,  United States; Recruiting
      Perry Memorial Hospital, Princeton,  Illinois,  61356,  United States; Recruiting
      Proctor Hospital, Peoria,  Illinois,  61614,  United States; Recruiting
      St. Anthony's Memorial Hospital, Effingham,  Illinois,  62401,  United States; Recruiting
      St. Joseph Medical Center, Bloomington,  Illinois,  61701,  United States; Recruiting
      St. Margaret's Hospital, Spring Valley,  Illinois,  61362,  United States; Recruiting
      Valley Cancer Center, Spring Valley,  Illinois,  61362,  United States; Recruiting
Indiana
      St. Francis Hospital and Health Centers, Beech Grove,  Indiana,  46107,  United States; Recruiting
Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
      Cedar Rapids Oncology Associates, Cedar Rapids,  Iowa,  52403-1206,  United States; Recruiting
      Des Moines General Hospital, Des Moines,  Iowa,  50309,  United States; Recruiting
      John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines,  Iowa,  50316-2301,  United States; Recruiting
      John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines,  Iowa,  50309,  United States; Recruiting
      Medical Oncology and Hematology Associates - West Des Moines, West Des Moines,  Iowa,  50266,  United States; Recruiting
      Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines,  Iowa,  50309,  United States; Recruiting
      Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines,  Iowa,  50314,  United States; Recruiting
      Mercy Cancer Center at Mercy Medical Center, Cedar Rapids,  Iowa,  52403,  United States; Recruiting
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States; Recruiting
      St. Luke's Hospital, Cedar Rapids,  Iowa,  52406,  United States; Recruiting
      St. Luke's Regional Medical Center, Sioux City,  Iowa,  51104,  United States; Recruiting
Kansas
      Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita,  Kansas,  67214,  United States; Recruiting
Minnesota
      Brainerd Medical Center, Brainerd,  Minnesota,  56401,  United States; Recruiting
      CentraCare Clinic - River Campus, St. Cloud,  Minnesota,  56303,  United States; Recruiting
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
      Merit Care Clinic - Bemidji, Bemidji,  Minnesota,  56601,  United States; Recruiting
Nebraska
      Bryan LGH Medical Center - East, Lincoln,  Nebraska,  68502-3780,  United States; Recruiting
      St. Elizabeth Regional Medical Center, Lincoln,  Nebraska,  68510-2494,  United States; Recruiting
North Carolina
      Rutherford Hospital, Rutherfordton,  North Carolina,  28139-0000,  United States; Recruiting
North Dakota
      Altru Cancer Center, Grand Forks,  North Dakota,  58201,  United States; Recruiting
      MeritCare Medical Group, Fargo,  North Dakota,  58103-2067,  United States; Recruiting
      Meritcare Roger Maris Cancer Center, Fargo,  North Dakota,  58122,  United States; Recruiting
Ohio
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
      Charles F. Kettering Memorial Hospital, Kettering,  Ohio,  45429,  United States; Recruiting
      Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia,  Ohio,  45385,  United States; Recruiting
      Samaritan North Cancer Care Center, Dayton,  Ohio,  45415,  United States; Recruiting
      Good Samaritan Hospital, Dayton,  Ohio,  45406-1891,  United States; Recruiting
      Grandview Hospital, Dayton,  Ohio,  45405,  United States; Recruiting
      Middletown Regional Hospital, Middletown,  Ohio,  45044-4898,  United States; Recruiting
      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428-1002,  United States; Recruiting
Pennsylvania
      Geisinger Medical Center, Danville,  Pennsylvania,  17822-0150,  United States; Recruiting
      Geisinger Medical Group, State College,  Pennsylvania,  16801,  United States; Recruiting
      Geisinger Wyoming Valley Medical Center, Wilkes Barre,  Pennsylvania,  18711,  United States; Recruiting
South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
      Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg,  South Carolina,  29303,  United States; Recruiting
      Rose Ramer Cancer Clinic at Andeson Area Medical Center, Anderson,  South Carolina,  29621,  United States; Recruiting
South Dakota
      Avera McKennan Hospital and University Health Center, Sioux Falls,  South Dakota,  57105-1080,  United States; Recruiting
      Medical X-Ray Center, Sioux Falls,  South Dakota,  57105,  United States; Recruiting
      Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
Wisconsin
      Bay Area Cancer Care Center at Bay Area Medical Center, Marinette,  Wisconsin,  54143,  United States; Recruiting
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting
      Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay,  Wisconsin,  54303,  United States; Recruiting
      Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay,  Wisconsin,  54301-3526,  United States; Recruiting
      St. Mary's Hospital Medical Center, Green Bay,  Wisconsin,  54303,  United States; Recruiting

Study chairs or principal investigators

Alex A. Adjei, MD, PhD,  Study Chair,  Mayo Clinic Cancer Center   
Donald W. Northfelt, MD, FACP,  Mayo Clinic Scottsdale   
Jann Nagina Sarkaria, MD,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000355117; NCCTG-N0323; NCT00079235
Record last reviewed:  January 2005
Last Updated:  April 4, 2005
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00079235
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08