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Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Advanced Non Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Advanced Non Small Cell Lung Cancer


OBJECTIVES: I. Determine the effect of acridine carboxamide on objective response, response
rate, and duration of response in patients with unresectable, locally advanced, progressive
or metastatic non-small cell lung cancer. II. Determine the toxicities and pharmacokinetics
of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive acridine carboxamide IV over 24 hours
for 5 days. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of
disease progression or unacceptable toxicity. Patients are followed every 6 weeks until
disease progression or commencement of another treatment.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven unresectable, locally advanced, progressive
or metastatic non-small cell lung cancer Not amenable to curative surgery or radiotherapy
No prior first line chemotherapy for metastatic or advanced disease At least 1
bidimensionally measurable target lesion by CT scan No symptomatic brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than
100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT, SGPT,
and alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastases
present) Renal: Creatinine no greater than 1.7 mg/dL Cardiovascular: No ischemic heart
disease within the past 6 months Normal 12 lead ECG Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception No other prior
or concurrent malignancy except cone biopsied carcinoma of the cervix or adequately
treated basal or squamous cell skin cancer No unstable systemic disease or active
uncontrolled infection No psychological, familial, sociological, or geographical condition
that could preclude compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At
least 4 weeks since prior radiotherapy Surgery: At least 2 weeks since prior major surgery
Other: No other concurrent anticancer agents No other concurrent investigational therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Axel R. Hanauske, MD, PhD, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

Haemato-Onkologische Praxis und Tagesklinik

Authority:

United States: Federal Government

Study ID:

EORTC-16991N

NCT ID:

NCT00004151

Start Date:

September 1999

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

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