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Home > "P" Clinical Trials Conditions > Phosphorus-32 Plus Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer  Phosphorus-32 Plus Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
Phosphorus-32 Plus Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
For Condition: stage 2 non-small cell lung cancer,stage 3A non-small cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Center for Molecular Medicine ,
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WayneCourt, Study Chair, Center for Molecular Medicine
Center for Molecular Medicine
Garden City, New York, 11530
United States
Additional Information:
Study ID Numbers: CDR0000067812; NCI-V00-1586,CMM-99003
Study Start Date: November 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006212
Other Stage 2 Non-Small Cell Lung Cancer Studies:
1. Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
2. EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
3. Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy
4. Docetaxel in Treating Patients With Non-Small Cell Lung Cancer
5. Polyglutamate Paclitaxel Compared With Gemcitabine or Vinorelbine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Related Studies:
Other stage 2 non-small cell lung cancer Clinical Trials
Other New York Clinical Trials
Other Garden City Clinical Trials
Phosphorus-32 Plus Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
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