Lung Cancer
Conditions
Keywords
extensive stage small cell lung cancer, recurrent small cell lung cancer
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.
Interventions
DRUGcisplatin
60 mg/m2 IV day 1, every 21 days for 4 cycles.
DRUGcyclophosphamide
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
DRUGetoposide
120 mg/m2 IV days 1-3 OR 120 mg/m2 IV day 1 and 120 mg/m2 by mouth BID days 2-3
Sponsors
Gundersen Lutheran Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | From time of registration to 30 days post treatment of last cycle. | — |
| Effect of metronomic chemotherapy on circulating endothelial cells | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | Registration to time of progression |
| Response rate | From Registration to time of disease progression |
| Overall survival | From registration to time patient expires |
Countries
United States
Outcome results
None listed