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Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
This study is currently recruiting participants.
Study NCT00083161   Information provided by National Cancer Institute (NCI)
First Received: May 14, 2004   Last Updated: December 10, 2008   History of Changes

May 14, 2004
December 10, 2008
June 2003
December 2011   (final data collection date for primary outcome measure)
  • Safety [ Designated as safety issue: Yes ]
  • Effect of metronomic chemotherapy on circulating endothelial cells [ Designated as safety issue: No ]
  • Safety
  • Effect of metronomic chemotherapy on circulating endothelial cells
Complete list of historical versions of study NCT00083161 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Designated as safety issue: No ]
  • Response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival
  • Response rate
  • Overall survival
 
Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin, etoposide, and cyclophosphamide together works in treating patients with extensive-stage small cell lung cancer.

OBJECTIVES:

Primary

  • Determine the safety of cisplatin, etoposide, and cyclophosphamide in patients with extensive stage small cell lung cancer.
  • Determine the effect of this regimen on circulating endothelial cells in the peripheral blood of these patients.

Secondary

  • Determine progression-free survival, tumor response rate, and overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction therapy: Patients receive cisplatin IV over 30 minutes-2 hours on day 1, etoposide IV over 1-2 hours on days 1-3 OR etoposide IV on day 1 and orally twice daily on days 2-3, and oral cyclophosphamide twice daily on days 8-19. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance therapy: Patients receive oral cyclophosphamide twice daily in the absence of disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Phase II
Interventional
Treatment
Lung Cancer
  • Drug: cisplatin
  • Drug: cyclophosphamide
  • Drug: etoposide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
10
 
December 2011   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer

    • Extensive stage disease (i.e., disease beyond the hemithorax and cannot be encompassed safely by a tolerable radiation field)
  • Measurable disease
  • Concurrent CNS metastases allowed provided patient remains asymptomatic

    • Radiotherapy or surgery for uncontrolled symptoms allowed before study entry

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8 g/dL (transfusion allowed)

Hepatic

  • ALT ≤ 2 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN

Renal

  • Creatinine ≤ 1.5 mg/dL OR
  • Creatinine clearance ≥ 60 mL/min

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past year except adequately treated basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Concurrent corticosteroids for brain metastases allowed

Radiotherapy

  • See Disease Characteristics
  • Prior radiotherapy to any symptomatic site allowed provided the target site(s) was not previously irradiated
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
Both
18 Years and older
No
 
United States
 
NCT00083161
Ronald S. Go, Gundersen Lutheran Center for Cancer and Blood
CDR0000363799, GLO-03-06-06
Gundersen Lutheran Center for Cancer and Blood
 
Study Chair: Ronald S. Go, MD Gundersen Lutheran Center for Cancer and Blood
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP