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

NCT ID: NCT00083161

Last Updated: 2012-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2010-05-31

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.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer; recurrent small cell lung cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral cyclophosphamide plus standard cisplatin with etoposide

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

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

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

cyclophosphamide

Intervention Type: DRUG

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

Intervention Type: DRUG

120 mg/m2 IV days 1-3 OR 120 mg/m2 IV day 1 and 120 mg/m2 by mouth BID days 2-3

Interventions

cisplatin

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Cytoxan; VP-16

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gundersen Lutheran Health System

OTHER

Sponsor Role: lead

Responsible Party

Ronald Go

Hematologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronald S. Go, MD

Role: STUDY_CHAIR

Gundersen Lutheran Center for Cancer and Blood

Locations

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, United States

Countries

United States

Other Identifiers

GLO-03-06-06

Identifier Type: -

Identifier Source: secondary_id

CDR0000363799

Identifier Type: -

Identifier Source: org_study_id