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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00083161
• Other study ID #: CDR0000363799
• Secondary ID: GLO-03-06-06
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2004
• Last updated: September 1, 2012
• Start date: June 2003
• Est. completion date: May 2010

Study information

• Verified date: September 2012
• Source: Gundersen Lutheran Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• cisplatin
60 mg/m2 IV day 1, every 21 days for 4 cycles.
• 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
• 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

Locations

Country	Name	City	State
United States	Gundersen Lutheran Center for Cancer and Blood	La Crosse	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Gundersen Lutheran Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety		From time of registration to 30 days post treatment of last cycle.	Yes
Primary	Effect of metronomic chemotherapy on circulating endothelial cells	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	No
Secondary	Progression-free survival		Registration to time of progression	No
Secondary	Response rate		From Registration to time of disease progression	No
Secondary	Overall survival		From registration to time patient expires	No