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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald Go, Gundersen Lutheran Health System
ClinicalTrials.gov Identifier:
NCT00083161
First received: May 14, 2004
Last updated: September 1, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gundersen Lutheran Health System:

Primary Outcome Measures:
  • Safety [ Time Frame: From time of registration to 30 days post treatment of last cycle. ] [ Designated as safety issue: Yes ]
  • Effect of metronomic chemotherapy on circulating endothelial cells [ Time Frame: Baseline to progression ] [ Designated as safety issue: No ]
    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 [ Time Frame: Registration to time of progression ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: From Registration to time of disease progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: From registration to time patient expires ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: June 2003
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: cisplatin
60 mg/m2 IV day 1, every 21 days for 4 cycles.
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
Other Name: Cytoxan
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
Other Name: VP-16

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083161

Locations
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Gundersen Lutheran Health System
Investigators
Study Chair: Ronald S. Go, MD Gundersen Lutheran Center for Cancer and Blood
  More Information

Additional Information:
No publications provided

Responsible Party: Ronald Go, Hematologist, Gundersen Lutheran Health System
ClinicalTrials.gov Identifier: NCT00083161     History of Changes
Other Study ID Numbers: CDR0000363799, GLO-03-06-06
Study First Received: May 14, 2004
Last Updated: September 1, 2012
Health Authority: United States: Federal Government

Keywords provided by Gundersen Lutheran Health System:
extensive stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Cyclophosphamide
Etoposide
Etoposide phosphate
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014