Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
This study has been completed.
Sponsor:
Gundersen Lutheran Health System
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
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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
|
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
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 March 03, 2015