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

Inclusion Criteria

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