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Phosphorus-32 Plus Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer - Article


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Clinical Trial: Phosphorus-32 Plus Radiation Therapy and Chemotherapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer

This study is no longer recruiting patients.

Sponsored by: Center for Molecular Medicine
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
stage IIIA non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIB non-small cell lung cancer
 Drug: cisplatin
 Drug: phosphorus P32
 Drug: vinblastine
Phase I

MedlinePlus related topics:  Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Interstitial Phosphorus P32 Colloid Plus Radiotherapy and Chemotherapy in Patients With Previously Untreated Stage II, IIIA, or IIIB Non-Small Cell Lung Cancer

Further Study Details: 

Study start: November 1999

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

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

Location Information


New York
      Center for Molecular Medicine, Garden City,  New York,  11530,  United States

Study chairs or principal investigators

Wayne S. Court,  Study Chair,  Center for Molecular Medicine   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067812; CMM-99003; NCI-V00-1586
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006212
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: November 22, 2004
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