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CCI-779 in Treating Patients With Stage IIIB (With Pleural Effusion) or Stage IV Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: North Central Cancer Treatment Group
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

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: CCI 779
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Confirmed response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival at 24 weeks [ Designated as safety issue: No ]
  • Survival time [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Effects of CCI-779 on mTOR [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: February 2004
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Must have accessible tumor (i.e., superficial lesions such as lymph node, subcutaneous nodules) to provide core needle biopsy tissue before and during study treatment
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079235

  Show 135 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000355117, NCCTG-N0323
Study First Received: March 8, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00079235  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Pleural Effusion
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009