Pyrazoloacridine in Treating Patients With Advanced Non-small Cell Lung Cancer

April 25, 2013 updated by: Barbara Ann Karmanos Cancer Institute

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy with pyrazoloacridine in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

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
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute

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 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

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: Pyrazoloacridine
Pyrazoloacridine 750 mg/m2 by 3 hour infusion, every 21 day s in the absence of progressive disease or prohibitive toxicity.
Drug: pyrazoloacridine

Pyrazoloacridine 750 mg/m2 by 3 hour infusion, every 21 day s in the absence of progressive disease or prohibitive toxicity.

Depending on the prior cycle toxicity the dose should be escalated, maintained or reduced, utilizing levels: -1, 0 (initial dose level), 1 - Level +1 (820mg/m2); Level 0 (750mg/m2); Level -1 (600mg/m2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate toxicity of pyrazoloacridine.
Time Frame: Weekly prior to each treatment cycle.
Weekly prior to each treatment cycle.

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the response frequency of pyrazoloacridine.
Time Frame: After 2 treatment cycles then every 2 months
After 2 treatment cycles then every 2 months

Collaborators and Investigators

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

Sponsor

Barbara Ann Karmanos Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Antoinette J. Wozniak, MD, Barbara Ann Karmanos Cancer Institute

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

October 1, 1995

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

June 9, 2004

First Posted (Estimate)

June 10, 2004

Study Record Updates

Last Update Posted (Estimate)

April 29, 2013

Last Update Submitted That Met QC Criteria

April 25, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000064199
  • P30CA022453 (U.S. NIH Grant/Contract)
  • WSU-C-1087-93
  • NCI-T94-0001H

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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