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

February 8, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
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.
Radiation: radiation therapy
Drug: topotecan hydrochloride

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1993

Primary Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 10, 2004

First Posted (Estimate)

March 11, 2004

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02487
  • NYU-9301
  • NCI-T93-0015D
  • CDR0000078480 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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