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Phase I Study of Interstitial Colloidal 32P Integrated With External Radiation Therapy and Chemotherapy in the Treatment of Non-Resectable or Medically Inoperable Non-Small Cell Carcinoma of the Lung


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Phase I Study of Interstitial Colloidal 32P Integrated With External Radiation Therapy and Chemotherapy in the Treatment of Non-Resectable or Medically Inoperable Non-Small Cell Carcinoma of the Lung


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Wayne S. Court, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Center for Molecular Medicine

Authority:

United States: Federal Government

Study ID:

CDR0000067812

NCT ID:

NCT00006212

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Center for Molecular MedicineGarden City, New York  11530