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Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00083161
Recruitment Status : Completed
First Posted : May 17, 2004
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
Ronald Go, Gundersen Lutheran Health System

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer
Study Start Date : June 2003
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral cyclophosphamide plus standard cisplatin with etoposide
  1. Etoposide 120 mg/m2 IV Days 1-3 or Etoposide 120 mg/ m2 IV Day1 followed by Etoposide 120 mg/ m2 PO BID Days 2-3
  2. Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles
  3. Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle
 Drug: cisplatin
60 mg/m2 IV day 1, every 21 days for 4 cycles.

Drug: cyclophosphamide
25 mg by mouth BID days 8-19 or each cycle x 4 cycles. After restaging (if no progression) maintenance cyclophosphamide alone 25 mg by mouth BID daily until disease progression
Other Name: Cytoxan

Drug: etoposide
120 mg/m2 IV days 1-3 OR 120 mg/m2 IV day 1 and 120 mg/m2 by mouth BID days 2-3
Other Name: VP-16


Outcome Measures
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Primary Outcome Measures :
  1. Safety [ Time Frame: From time of registration to 30 days post treatment of last cycle. ]
  2. Effect of metronomic chemotherapy on circulating endothelial cells [ Time Frame: Baseline to progression ]
    Collected cycle 1/day 1 of chemotherapy, Cycle 1/day 8, cycle 1/day 22, and then day 85 and 141, and at disease progression.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: Registration to time of progression ]
  2. Response rate [ Time Frame: From Registration to time of disease progression ]
  3. Overall survival [ Time Frame: From registration to time patient expires ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083161


Locations
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United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Gundersen Lutheran Health System
Investigators
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Study Chair: Ronald S. Go, MD Gundersen Lutheran Center for Cancer and Blood
More Information
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Responsible Party: Ronald Go, Hematologist, Gundersen Lutheran Health System
ClinicalTrials.gov Identifier: NCT00083161    
Other Study ID Numbers: CDR0000363799
GLO-03-06-06
First Posted: May 17, 2004    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012
Keywords provided by Ronald Go, Gundersen Lutheran Health System:
extensive stage small cell lung cancer
recurrent small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cyclophosphamide
Etoposide
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors