Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

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.

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.

Eligibility 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