Completed

Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer

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What is being tested

cisplatin

+ cyclophosphamide

+ etoposide

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Lung Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2003
See protocol details

Summary

Principal SponsorGundersen Lutheran Health System
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitlePilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed Extensive Stage Small Cell Lung Cancer 
NCT00083161
Principal SponsorGundersen Lutheran Health System
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

8 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsSmall Cell Lung Carcinoma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Gundersen Lutheran Center for Cancer and Blood

La Crosse, United StatesSee the location
CompletedOne Study Center