Belotecan and Cisplatin in Treating Patients With Previously Untreated, Extensive-Stage Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Belotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving belotecan together with cisplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well belotecan works when given together with cisplatin in treating patients with previously untreated extensive stage small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary To assess the antitumor efficacy, in terms of objective response rate, of belotecan hydrochloride and cisplatin in patients with previously untreated extensive-stage small cell lung cancer. Secondary To assess additional evidence of antitumor activity as measured by overall and progression-free survival of these patients. To determine the safety and tolerability of this drug combination in these patients. OUTLINE: Patients receive cisplatin IV on day 1 and belotecan hydrochloride IV on days 2-4.Treatment continues in the absence of disease progression or unacceptable toxicity.

Official Title
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Phase II Study of Camtobell Inj.(Belotecan) in Combination With Cisplatin in Patients With Previously Untreated, Extensive-stage Small-cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: belotecan hydrochloride
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed small cell lung cancer meeting the following criteria: Extensive-stage disease Previously untreated disease At least one measurable disease No brain or leptomeningeal metastasis PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 12 weeks ANC ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 1.5 mg/dL ALT and AST ≤ 2.0 times upper normal limit (ULN) (≤ 5.0 times ULN in the presence of liver metastasis) Alkaline phosphatase ≤ 2.0 times ULN Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min No active infection requiring intravenous antibiotics No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ cancer No other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, interfere with the interpretation of study results, or make the patient ineligible for study entry, in the judgment of the investigator PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy No other concurrent chemotherapy, radiotherapy, or immunotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: belotecan and Cisplatin<br>belotecan 0.5 mg/m2 and Cisplatin 60mg/m2 | Drug: belotecan hydrochloride<br> <br> Drug: cisplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate as assessed by RECIST criteria |  | 21days(1cycle) | 
| Overall survival |  | 21days(1cycle) | 
| Progression-free survival |  | 21days(1cycle) | 
| Hematologic and non-hematologic toxicity as assessed by NCI CTCAE v3.0 |  | 21days(1cycle) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extensive stage small cell lung cancer