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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 has been completed.

First Received on March 8, 2004.   Last Updated on December 3, 2009   History of Changes
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: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:


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
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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
Investigator: Jann N. Sarkaria, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00079235     History of Changes
Other Study ID Numbers: CDR0000355117, NCCTG-N0323
Study First Received: March 8, 2004
Last Updated: December 3, 2009
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pleural Effusion
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on February 12, 2012