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

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

Sponsors

Lead sponsor: Gundersen Lutheran Health System

Source Gundersen Lutheran Health System
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.

Overall Status Completed
Start Date June 2003
Completion Date May 2010
Primary Completion Date May 2010
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety From time of registration to 30 days post treatment of last cycle.
Effect of metronomic chemotherapy on circulating endothelial cells Baseline to progression
Secondary Outcome
Measure Time Frame
Progression-free survival Registration to time of progression
Response rate From Registration to time of disease progression
Overall survival From registration to time patient expires
Enrollment 8
Condition
Intervention

Intervention type: Drug

Intervention name: cisplatin

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

Arm group label: Oral cyclophosphamide plus standard cisplatin with etoposide

Intervention type: Drug

Intervention name: cyclophosphamide

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

Arm group label: Oral cyclophosphamide plus standard cisplatin with etoposide

Other name: Cytoxan

Intervention type: Drug

Intervention name: etoposide

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

Arm group label: Oral cyclophosphamide plus standard cisplatin with etoposide

Other name: VP-16

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Ronald S. Go, MD Study Chair Gundersen Lutheran Center for Cancer and Blood
Location
facility Gundersen Lutheran Center for Cancer and Blood
Location Countries

United States

Verification Date

September 2012

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Gundersen Lutheran Health System

Investigator full name: Ronald Go

Investigator title: Hematologist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Oral cyclophosphamide plus standard cisplatin with etoposide

Arm group type: Experimental

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

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov