Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed unresectable stage IIIB non-small cell lung cancer

• Squamous cell carcinoma

• Adenocarcinoma

• Large cell carcinoma

• Non-small cell carcinoma not otherwise specified

• All detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields

• Measurable disease on 3-dimensional planning CT scan

• No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma

• No stage IV or recurrent disease

• No distant metastases or supraclavicular lymph node involvement

• No significant atelectasis (i.e., atelectasis of an entire lung)

• No pleural effusions, pericardial effusions, or superior vena cava syndrome

• No lung cancer within the past 2 years

• Ineligible for currently open Radiation Therapy Oncology Group (RTOG) phase III lung protocols

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin less than 1.5 mg/dL

• Aspartate aminotransferase (AST) less than 2 times upper limit of normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Pulmonary:

• Forced expiratory volume (FEV)_1 at least 1.0 L

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No weight loss greater than 5% in the past 6 months

• No other malignancy within the past year except nonmelanoma skin cancer

• Completed 3D plan with total lung V20esophageal V55 PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic response modifiers for current lung cancer

• At least 5 years since prior biologic response modifiers

Chemotherapy:

• No prior chemotherapy for current lung cancer

• At least 5 years since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No prior radiotherapy to the thorax

Surgery:

• No prior complete tumor resection