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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Motexafin gadolinium; Paclitaxel

Criteria

Inclusion Criteria:

• 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

• No prior chest radiotherapy in area of tumor/nodes

• No other concurrent investigational agents