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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02487

NCT ID:

NCT00002537

Start Date:

September 1993

Completion Date:

Related Keywords:

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

Name

Location
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016