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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Pilot Study of a Combination of Standard Etoposide/Cisplatin and Metronomic Cyclophosphamide in Patients With Newly Diagnosed 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Time Frame:

From time of registration to 30 days post treatment of last cycle.

Safety Issue:

Yes

Principal Investigator

Ronald S. Go, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gundersen Lutheran Center for Cancer and Blood

Authority:

United States: Federal Government

Study ID:

CDR0000363799

NCT ID:

NCT00083161

Start Date:

June 2003

Completion Date:

May 2010

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601