Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH CHEST IRRADIATION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002537
• Other study ID #: NCI-2012-02487
• Secondary ID: NYU-9301NCI-T93-
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: February 8, 2013
• Start date: September 1993

Study information

• Verified date: May 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Phase I trial to study the effectiveness of radiation therapy plus topotecan in treating patients who have non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy and radiation therapy may kill more tumor cells.

Description:

OBJECTIVES:

I. Determine the maximum tolerated dose of topotecan and chest irradiation in patients with non-small cell lung cancer.

II. Determine the qualitative and quantitative toxic effects of this regimen in these patients.

III. Determine the degree of antitumor activity of this regimen in these patients.

OUTLINE: This is a dose escalation study of topotecan and thoracic radiotherapy.

Beginning on day 1, patients receive topotecan IV continuously for 3-6 weeks and thoracic radiotherapy 5 days a week for 2, 3, or 6 weeks. Cohorts of 4-6 patients receive escalating doses of topotecan and thoracic radiotherapy until the maximum tolerated dose (MTD) of each therapy is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity. Six additional patients are treated at the MTD. Patients who fail to achieve complete remission (CR) and continue to have measurable disease at 4-6 weeks after completion of radiotherapy receive topotecan IV continuously on days 1-21 at 1 dose level preceding the MTD as determined by the ongoing Protocol NYU-9123. Treatment continues every 4 weeks in the absence of unacceptable toxicity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven non-small cell lung cancer

• Eligible for chest irradiation with 3,000 to 6,000 cGy (based upon standard radiotherapy indications)

• Measurable or evaluable disease

• Measurable disease defined as bidimensionally measurable lesion on physical exam or radiograph (CT or MRI acceptable)

PATIENT CHARACTERISTICS:

• Age: 18 and over

• Performance status: 0-2

• Life expectancy: At least 12 weeks

• WBC at least 4,000/mm3

• Platelet count at least 100,000/mm3

• Bilirubin no greater than 1.5 mg/dL

• AST less than 3 times normal

• Alkaline phosphatase less than 3 times normal

• Creatinine no greater than 1.5 mg/dL

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

• No more than 1 prior chemotherapy regimen allowed

• At least 4 weeks since prior chemotherapy and recovered

• No prior radiotherapy

• Recovered from toxic effects of any prior therapy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• topotecan hydrochloride

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,