Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have relapsed or progressive small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine the efficacy of temozolomide, in terms of response rate and safety, in patients with relapsed or progressive small cell lung cancer. Determine the time to progression and overall survival in patients treated with this drug. Assess quality of life of patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy). Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to each course of chemotherapy, at 30 days after study completion, and then every 8 weeks thereafter. Patients are followed at 30 days and then every 8 weeks thereafter. PROJECTED ACCRUAL: A total of 37-79 patients (14-33 chemosensitive and 23-46 chemoresistant) will be accrued for this study.

Official Title
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A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: temozolomide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed relapsed or progressive small cell lung cancer Classical or intermediate variant OR Relapsed or progressive extrapulmonary small cell carcinoma of unknown origin Bidimensionally measurable disease At least 1 cm by 1 cm by physical exam or radiologic exam Outside prior radiation port unless clinical evidence of disease progression Previously radiated brain metastases allowed provided stable or improved PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT/SGPT no greater than 3 times ULN (5 times ULN if liver metastases present) Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater than 2 mg/dL Other: HIV negative No AIDS-related illness No frequent vomiting or medical condition that would interfere with oral medication administration (e.g., partial bowel obstruction) No active nonmalignant systemic disease that would preclude study No other active invasive malignancy within the past year or concurrently requiring ongoing treatment Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for at least 1 month before, during, and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy No concurrent immunotherapy No concurrent biologic therapy Concurrent epoetin alfa allowed Chemotherapy: At least 4 weeks since prior chemotherapy No more than 1 prior continuous or discontinuous chemotherapy regimen for metastatic disease No other concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy to boost appetite allowed (e.g., corticosteroids or medroxyprogesterone) Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy to 15% or more of bone marrow At least 1 week since prior radiotherapy to less than 15% of bone marrow No prior radiotherapy to 50% or more of bone marrow No concurrent radiotherapy Surgery: Not specified Other: Recovered from prior therapy No other concurrent investigational drugs Concurrent pamidronate allowed

Ages Eligible for Study
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Minimum Age: 18 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: Temozolomide<br>Temozolomide 150mg/m2/day daily. Repeat cycles every 28days for maximum of six months | Drug: temozolomide<br>* 150 mg/m2/day Repeat cycles every 28 days following first daily dose of each cycle until toxicity or disease progression for a maximum of six months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent small cell lung cancer, intermediate type small cell lung cancer