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

Sponsor:	Gundersen Lutheran Center for Cancer and Blood
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00083161

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 II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cyclophosphamide Cisplatin Etoposide Etoposide phosphate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety [ Designated as safety issue: Yes ]
Effect of metronomic chemotherapy on circulating endothelial cells [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival [ Designated as safety issue: No ]
Response rate [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	June 2003
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

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

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

Locations

United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood	Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center 608-775-2385 cancerctr@gundluth.org

Sponsors and Collaborators

Gundersen Lutheran Center for Cancer and Blood

Investigators

Study Chair:

Ronald S. Go, MD

Gundersen Lutheran Center for Cancer and Blood

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gundersen Lutheran Center for Cancer and Blood ( Ronald S. Go )
Study ID Numbers:	CDR0000363799, GLO-03-06-06
Study First Received:	May 14, 2004
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00083161 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

extensive stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Cyclophosphamide
Etoposide phosphate
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses

Alkylating Agents
Etoposide
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Immunosuppressive Agents
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Myeloablative Agonists
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on November 05, 2009