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CCI-779 in Treating Patients With Extensive-Stage Small Cell Lung Cancer
This study has been completed.
First Received: December 7, 2001   Last Updated: July 23, 2008   History of Changes
Sponsor: Eastern Cooperative Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00028028
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: temsirolimus
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized, Phase II ECOG Trial of Two Dose Levels of CCI-779 in Patients With Extensive-Stage Small Cell Lung Cancer Who Have Responding or Stable Disease After Induction Chemotherapy

Resource links provided by NLM:


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

Study Start Date: January 2002
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00028028

  Hide Study Locations
Locations
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Evanston
Evanston, Illinois, United States, 60201
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, United States, 60611-4494
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
United States, Louisiana
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-1000
United States, Massachusetts
Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07019
United States, New York
Albert Einstein Clinical Cancer Center
Bronx, New York, United States, 10461
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, United States, 10466
United States, Ohio
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6307
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States, 54307-3453
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Kishan J. Pandya, MD James P. Wilmot Cancer Center
  More Information

Additional Information:
Publications:
Pandya KJ, Dahlberg S, Hidalgo M, Cohen RB, Lee MW, Schiller JH, Johnson DH; Eastern Cooperative Oncology Group (E1500). A randomized, phase II trial of two dose levels of temsirolimus (CCI-779) in patients with extensive-stage small-cell lung cancer who have responding or stable disease after induction chemotherapy: a trial of the Eastern Cooperative Oncology Group (E1500). J Thorac Oncol. 2007 Nov;2(11):1036-41.
Pandya KJ, Levy DE, Hidalgo M, et al.: A randomized, phase II ECOG trial of two dose levels of temsirolimus (CCI-779) in patients with extensive stage small cell lung cancer in remission after induction chemotherapy. A preliminary report. [Abstract] J Clin Oncol 23 (Suppl 16): A-7005, 622s, 2005.

Study ID Numbers: CDR0000069118, ECOG-E1500
Study First Received: December 7, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00028028     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Carcinoma, Neuroendocrine
Neoplasms, Nerve Tissue
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009