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

September 1, 2012 updated by: Ronald Go, Gundersen Lutheran Health System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Center for Cancer and Blood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • VP-16

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: From time of registration to 30 days post treatment of last cycle.
From time of registration to 30 days post treatment of last cycle.
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.
Baseline to progression

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: Registration to time of progression
Registration to time of progression
Response rate
Time Frame: From Registration to time of disease progression
From Registration to time of disease progression
Overall survival
Time Frame: From registration to time patient expires
From registration to time patient expires

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gundersen Lutheran Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 14, 2004

First Submitted That Met QC Criteria

May 14, 2004

First Posted (Estimate)

May 17, 2004

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 1, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000363799
  • GLO-03-06-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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