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| Sponsored by: |
Center for Molecular Medicine |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006212 |
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 | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: cisplatin Drug: vinblastine Radiation: phosphorus P32 Radiation: radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | 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 |
| Study Start Date: | 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.
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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Center for Molecular Medicine | |
| Garden City, New York, United States, 11530 | |
| Study Chair: | Wayne S. Court, MD, PhD | Center for Molecular Medicine |
More Information
| Study ID Numbers: | CDR0000067812, CMM-99003, NCI-V00-1586 |
| Study First Received: | September 11, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006212 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
|
Thoracic Neoplasms Vinblastine Antimitotic Agents Carcinoma Respiratory Tract Diseases Cisplatin Lung Neoplasms |
Lung Diseases Tubulin Modulators Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Vinblastine Antimitotic Agents Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Tubulin Modulators Carcinoma, Non-Small-Cell Lung Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
