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PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CARCINOMA


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

Thank you

Trial Information

PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CARCINOMA


OBJECTIVES: I. Evaluate the antitumor activity of pyrazoloacridine (PZA) administered by
3-hour infusion to patients with advanced non small cell lung cancer (NSCLC). II. Determine
the qualitative and quantitative toxicities of PZA administered on this schedule. III.
Determine the response and survival durations of NSCLC patients treated with PZA.

OUTLINE: Single-Agent Chemotherapy. Pyrazoloacridine, PZA, NSC-366140.

PROJECTED ACCRUAL: If 2 or 3 responses are observed in the first 18 evaluable patients, 12
additional patients will be entered. Accrual is expected to take 5-12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed non small cell lung cancer ineligible
for higher priority protocols Sputum cytology acceptable Stage IIIB/IV Must have
measurable or evaluable disease Lesion outside prior radiotherapy fields Cytology-positive
pleural effusion and ascites are neither measurable nor evaluable No brain metastases on
CT

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute granulocyte count greater than 2,000/mm3 Platelet
count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine
less than 1.5 mg/dL Other: No pregnant or nursing women Negative pregnancy test required
of fertile women Effective contraception required of fertile patients Blood/body fluid
analyses within 7 days prior to registration Imaging/exams for tumor measurement within 28
days prior to registration

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One prior adjuvant
or neoadjuvant chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: At
least 4 weeks since radiotherapy and recovered AND Progressive disease outside of
radiation port Surgery: Recovered from any prior surgery

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate toxicity of pyrazoloacridine.

Outcome Time Frame:

Weekly prior to each treatment cycle.

Safety Issue:

Yes

Principal Investigator

Antoinette J. Wozniak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000064199

NCT ID:

NCT00002656

Start Date:

October 1995

Completion Date:

February 2008

Related Keywords:

  • Lung Cancer
  • recurrent 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

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201