Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00083161 |
Recruitment Status :
Completed
First Posted : May 17, 2004
Last Update Posted : September 5, 2012
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Drug: cisplatin Drug: cyclophosphamide Drug: etoposide | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | June 2003 |
Actual Primary Completion Date : | May 2010 |
Actual Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Oral cyclophosphamide plus standard cisplatin with etoposide
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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 |
- Safety [ Time Frame: From time of registration to 30 days post treatment of last cycle. ]
- Effect of metronomic chemotherapy on circulating endothelial cells [ Time Frame: Baseline to progression ]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.
- Progression-free survival [ Time Frame: Registration to time of progression ]
- Response rate [ Time Frame: From Registration to time of disease progression ]
- Overall survival [ Time Frame: From registration to time patient expires ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00083161
United States, Wisconsin | |
Gundersen Lutheran Center for Cancer and Blood | |
La Crosse, Wisconsin, United States, 54601 |
Study Chair: | Ronald S. Go, MD | Gundersen Lutheran Center for Cancer and Blood |
Responsible Party: | Ronald Go, Hematologist, Gundersen Lutheran Health System |
ClinicalTrials.gov Identifier: | NCT00083161 |
Other Study ID Numbers: |
CDR0000363799 GLO-03-06-06 |
First Posted: | May 17, 2004 Key Record Dates |
Last Update Posted: | September 5, 2012 |
Last Verified: | September 2012 |
extensive stage small cell lung cancer recurrent small cell lung cancer |
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Cyclophosphamide Etoposide Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |