Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer

Completed · Phase 1

Conditions studied: Stage IIIA Non-small Cell Lung Cancer

In brief

Phase I trial to study the effectiveness of combining carboplatin and paclitaxel, radiation therapy with gadolinium texaphyrin, and surgery in treating patients who have stage IIIA non-small cell lung cancer. 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. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells.

Key facts

Study ID

NCT00005065

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2000-01-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed non-small cell carcinoma of the lung
• Surgical staging with mediastinoscopy or anterior thoracotomy required
• T1-T3, N2, M0
• Must appear resectable
• Performance status - Karnofsky 70-100%
• WBC at least 3,000/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin normal
• AST no greater than 2.5 times upper limit of normal
• Creatinine no greater than 2 mg/dL
• Creatinine clearance at least 60 mL/min
• No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• FEV greater than 0.8 L
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Weight loss no greater than 10% of total body weight within past 3 months
• No evidence of neuropathy
• No history of allergy to platinum compounds, paclitaxel, porphyrins, or antiemetics appropriate for administration in conjunction with protocol chemotherapy
• No concurrent uncontrolled illness (e.g., active infection)
• No medical contraindication to MRI (e.g., pacemaker or aneurysm clip)
• No G6PD deficiency
• No known history of porphyria
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Where it is running

• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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