phosphorus-32 plus radiation therapy and chemotherapy in treating patients with stage ii or stage iii non-small cell lung cancer

Conditions: Lung Cancer

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. drugs such as phosphorus-32 may make the tumor cells more sensitive to radiation therapy. chemotherapy combined with radiation therapy and phosphorus-32 may kill more tumor cells. purpose: phase i trial to study the effectiveness of phosphorus-32 plus radiation therapy and chemotherapy in treating patients who have stage ii or stage iii non-small cell lung cancer.

objectives: i. determine the dosimetry and toxicity of interstitial phosphorus p32 colloid plus chemotherapy and radiotherapy in patients with previously untreated stage ii, iiia, or iiib non-small cell lung cancer. ii. determine the maximum tolerated dose of phosphorus p32 colloid in these patients. iii. determine the response in patients treated with this regimen. outline: this is a dose escalation study of phosphorus p32 colloid. patients receive vinblastine iv on days 1, 8, 15, 22, and 29; cisplatin iv over 30-60 minutes on days 1 and 29; and phosphorus p32 colloid interstitially on day 50. patients with tumor size less than 8.0 cm receive radiotherapy following phosphorus p32 injection 5 days a week for 6.5 weeks. patients with tumor size greater than 8.0 cm receive radiotherapy 5 days a week for 4.5 weeks prior to phosphorus p32 injection, and for an additional 2.5 weeks following injection. cohorts of 3 patients receive escalating doses of phosphorus p32 colloid until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicity. patients are followed every 3 months for 2 years, and then every 6 months thereafter. projected accrual: a total of 50 patients will be accrued for this study within 4 years.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed, previously untreated stage ii, iiia, or iiib non-small cell lung cancer unresectable or inoperable disease or refusal of surgery tumor reachable by ct guided needle placement bidimensionally measurable disease by chest x-ray or ct scan no clinical/radiographic evidence of metastatic disease patient characteristics: age: over 18 performance status: karnofsky 60-100% life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 neutrophil count at least 1,900/mm3 platelet count at least 100,000/mm3 hemoglobin at least 9 g/dl (transfusion allowed) hepatic: adequate hepatic function renal: bun no greater than 25 mg/dl creatinine no greater than 1.5 mg/dl other: less than 5% weight loss able to receive induction chemotherapy no second malignancy within the past 5 years except skin cancer not pregnant negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: not specified radiotherapy: no prior radiotherapy to thorax surgery: see disease characteristics no prior resection at primary site

Keywords: stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer