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Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer

This study has been completed.

Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00022711
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have relapsed or progressive small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: temozolomide
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Temozolomide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer

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

Study Start Date:   October 2001

Detailed Description:

OBJECTIVES:

  • Determine the efficacy of temozolomide, in terms of response rate and safety, in patients with relapsed or progressive small cell lung cancer.
  • Determine the time to progression and overall survival in patients treated with this drug.
  • Assess quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy).

Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed prior to each course of chemotherapy, at 30 days after study completion, and then every 8 weeks thereafter.

Patients are followed at 30 days and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 37-79 patients (14-33 chemosensitive and 23-46 chemoresistant) will be accrued for this study.

  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 relapsed or progressive small cell lung cancer

    • Classical or intermediate variant OR
    • Relapsed or progressive extrapulmonary small cell carcinoma of unknown origin
  • Bidimensionally measurable disease

    • At least 1 cm by 1 cm by physical exam or radiologic exam
    • Outside prior radiation port unless clinical evidence of disease progression
  • Previously radiated brain metastases allowed provided stable or improved

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT/SGPT no greater than 3 times ULN (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 5 times ULN

Renal:

  • Creatinine no greater than 2 mg/dL

Other:

  • HIV negative
  • No AIDS-related illness
  • No frequent vomiting or medical condition that would interfere with oral medication administration (e.g., partial bowel obstruction)
  • No active nonmalignant systemic disease that would preclude study
  • No other active invasive malignancy within the past year or concurrently requiring ongoing treatment
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy
  • No concurrent immunotherapy
  • No concurrent biologic therapy
  • Concurrent epoetin alfa allowed

Chemotherapy:

  • At least 4 weeks since prior chemotherapy
  • No more than 1 prior continuous or discontinuous chemotherapy regimen for metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent hormonal therapy to boost appetite allowed (e.g., corticosteroids or medroxyprogesterone)

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy to 15% or more of bone marrow
  • At least 1 week since prior radiotherapy to less than 15% of bone marrow
  • No prior radiotherapy to 50% or more of bone marrow
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • Recovered from prior therapy
  • No other concurrent investigational drugs
  • Concurrent pamidronate allowed
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022711

Locations
United States, New Jersey
Community Medical Center    
      Toms River, New Jersey, United States, 08755
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County    
      Mount Holly, New Jersey, United States, 08060
Hunterdon Regional Cancer Center    
      Flemington, New Jersey, United States, 08822
St. Francis Medical Center    
      Trenton, New Jersey, United States, 08629
Riverview Medical Center - Booker Cancer Center    
      Red Bank, New Jersey, United States, 07701
South Jersey Regional Cancer Center    
      Millville, New Jersey, United States, 08332
Kimball Medical Center    
      Lakewood, New Jersey, United States, 08701
United States, Pennsylvania
Bon Secours-Holy Family Health System    
      Altoona, Pennsylvania, United States, 16602
Saint Mary Regional Center    
      Langhorne, Pennsylvania, United States, 19047
Conemaugh Memorial Hospital    
      Johnstown, Pennsylvania, United States, 15905
Delaware County Memorial Hospital    
      Drexel Hill, Pennsylvania, United States, 19026-1186
Fox Chase Cancer Center    
      Philadelphia, Pennsylvania, United States, 19111
Paoli Memorial Hospital    
      Paoli, Pennsylvania, United States, 19301-1792
Pinnacle Health Hospitals    
      Harrisburg, Pennsylvania, United States, 17105-8700
Pottstown Memorial Regional Cancer Center    
      Pottstown, Pennsylvania, United States, 19464
Reading Hospital and Medical Center    
      Reading, Pennsylvania, United States, 19612-6052
Central Montgomery Medical Center    
      Lansdale, Pennsylvania, United States, 19446-1200

Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Corey J. Langer, MD     Fox Chase Cancer Center    
  More Information


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

Study ID Numbers:   CDR0000068844, FCCC-01020, SPRI-H-P00740, NCI-G01-2005
First Received:   August 10, 2001
Last Updated:   October 12, 2008
ClinicalTrials.gov Identifier:   NCT00022711
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent small cell lung cancer  
intermediate type small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Temozolomide
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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