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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Etoposide; Etoposide phosphate; Lenograstim; Paclitaxel; Topotecan

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