Surgery, Gemcitabine, Cisplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well surgery followed by gemcitabine, cisplatin, and radiation therapy works in treating patients with stage II or stage III non-small cell lung cancer.

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

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed single, primary bronchogenic non-small cell lung cancer meeting the following subtypes:

• Adenocarcinoma (no bronchioalveolar cell histology)

• Squamous cell carcinoma

• Large cell carcinoma

• Meeting the following staging criteria:

• Stage IIB (T2, N1, M0, or T3, N0, M0)

• Stage IIIA (T1-3, N2, M0 or T3, N1, M0)

• Stage IIIB (Any T, N3, M0 or T4, Any N, M0)

• No more than 1 parenchymal lesion in the same lung or in both lungs

• No tumor involving the superior sulcus (e.g., Pancoast tumor)

• Patients must undergo evaluation by the involved thoracic surgeon, medical oncologist, and radiation oncologist prior to registration

• No evidence of metastatic disease

• Biopsy or aspiration cytology required to confirm the benign diagnosis of CT or MRI abnormalities that potentially represent metastatic disease

• Biopsy required if all noninvasive tests are indeterminant

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Absolute granulocyte count ≥ 1,500/μL

• Platelet count ≥ 100,000/μL

• Bilirubin ≤ 3 times upper limit of normal (ULN)

• SGOT and SGPT ≤ 3 times ULN

• Creatinine clearance > 50 mL/min

• No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, or any other cancer from which the patient has been disease-free for 5 years

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective protection

• No significant hearing loss or patient unwilling to accept potential for further hearing loss

• No uncontrolled medical illness by appropriate medical therapy (e.g., myocardial infarction within the past 3 months or liver cirrhosis)

• No symptomatic peripheral neuropathy affecting activities of daily living

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy for lung cancer