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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
cyclophosphamide
etoposide
Sponsored by
Gundersen Lutheran Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer, recurrent small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gundersen Lutheran Center for Cancer and Blood

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral cyclophosphamide plus standard cisplatin with etoposide

Arm Description

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 Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle

Outcomes

Primary Outcome Measures

Safety
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.

Secondary Outcome Measures

Progression-free survival
Response rate
Overall survival

Full Information

First Posted
May 14, 2004
Last Updated
September 1, 2012
Sponsor
Gundersen Lutheran Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00083161
Brief Title
Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gundersen Lutheran Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
extensive stage small cell lung cancer, recurrent small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral cyclophosphamide plus standard cisplatin with etoposide
Arm Type
Experimental
Arm Description
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 Cisplatin 60 mg/m2 IV Day 1 Every 21 days x 4 cycles Cyclophosphamide 25 mg PO BID Days 8-19 of each cycle
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
60 mg/m2 IV day 1, every 21 days for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
VP-16
Intervention Description
120 mg/m2 IV days 1-3 OR 120 mg/m2 IV day 1 and 120 mg/m2 by mouth BID days 2-3
Primary Outcome Measure Information:
Title
Safety
Time Frame
From time of registration to 30 days post treatment of last cycle.
Title
Effect of metronomic chemotherapy on circulating endothelial cells
Description
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.
Time Frame
Baseline to progression
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
Registration to time of progression
Title
Response rate
Time Frame
From Registration to time of disease progression
Title
Overall survival
Time Frame
From registration to time patient expires

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald S. Go, MD
Organizational Affiliation
Gundersen Lutheran Center for Cancer and Blood
Official's Role
Study Chair
Facility Information:
Facility Name
Gundersen Lutheran Center for Cancer and Blood
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

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

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