Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine the complete and overall response rates in patients with limited stage small cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan, and etoposide followed by consolidation chemoradiotherapy. Determine the toxicity of this regimen in these patients. Determine the overall and failure-free survival of patients treated with this regimen. Determine the overall (partial and complete) response rate in patients treated with this induction chemotherapy regimen. OUTLINE: This is a multicenter study. Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10 months.

Official Title
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Paclitaxel/Topotecan/Etoposide (EtopoTax) Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: filgrastim
* Drug: carboplatin
* Drug: etoposide
* Drug: paclitaxel
* Drug: topotecan hydrochloride
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed small cell lung cancer Limited stage defined as disease restricted to one hemithorax with regional lymph node metastases including hilar, ipsilateral, and contralateral mediastinal lymph nodes Measurable disease At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Lesions not considered measurable include the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions in a previously irradiated area No clinically suspected or confirmed supraclavicular lymph node metastases No pleural effusions visible on plain chest radiographs, regardless of cytology PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,00/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than ULN Creatinine clearance no greater than 150 mL/min for men or 130 mL/min for women Other: Not pregnant or nursing Fertile patients must use effective contraception No other currently active malignancy except non-melanoma skin cancer Patients must have completed therapy for any other malignancy and be considered to be at less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) during consolidation therapy Chemotherapy: No prior chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except: Steroids for adrenal failure Hormones for non-disease-related conditions (e.g., insulin for diabetes) Intermittent use of dexamethasone as an antiemetic or as an adjunct to prophylactic cranial irradiation Radiotherapy: See Disease Characteristics No prior chest radiotherapy Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: chemotherapy + radiation therapy<br>Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and continuing until blood counts recover. Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and 85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks. Patients with rapid disease progression discontinue study therapy. Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. | Biological: filgrastim<br> <br> Drug: carboplatin<br> <br> Drug: etoposide<br> <br> Drug: paclitaxel<br> <br> Drug: topotecan hydrochloride<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure-free survival |  | up to 5 years | 
| overall survival |  | up to 5 years | 

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