Gemcitabine Plus Radiation Therapy or Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

• Status: Completed
• Trial end date: 2006-07-01
• 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 radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to compare the effectiveness of gemcitabine with radiation therapy alone or following two-drug combination chemotherapy in treating patients with stage III non-small cell lung cancer.

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

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IIIA or IIIB non-small cell lung cancer that is unicentric and inoperable, including the following cellular types:

• Squamous cell carcinoma

• Adenocarcinoma

• Bronchoalveolar carcinoma

• Large cell anaplastic carcinoma

• Non-small cell lung cancer not otherwise specified

• Tumors may be multifocal if all of disease is believed to be result of direct spread

• Disease must be fully accessible by radiotherapy ports for the entire prescribed dose

• No supraclavicular nodes or diffuse pleural involvement

• No contralateral hilar disease or an exudative, bloody, or cytologically malignant effusion

• Measurable disease required for phase II of this study

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• ECOG 0-2

Life expectancy:

• At least 1 year

Hematopoietic:

• Granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin greater than 10 g/dL

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

Renal:

• BUN no greater than 1.5 times normal

• Creatinine no greater than 1.5 times normal

Pulmonary:

• FEV1 no greater than 1 liter except if tumor has negatively impacted

• pulmonary function

Other:

• No other serious medical or psychiatric illness

• No prior lung cancer except if free of disease for more than 3 years

• No other prior malignancy except nonmelanoma skin cancer or if free of

• disease for more than 1 year

• Not pregnant or nursing

• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior thoracic radiotherapy

• Concurrent radiotherapy to other anatomic sites allowed

Surgery:

• Not specified