Lung CancerPhase 2NCT00002656
Pyrazoloacridine in Treating Patients With Advanced Non-small Cell Lung Cancer
A Phase 2 study testing pyrazoloacridine in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- pyrazoloacridine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1995to Feb 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- pyrazoloacridine
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrazoloacridineDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Pyrazoloacridine | Experimental | Pyrazoloacridine 750 mg/m2 by 3 hour infusion, every 21 day s in the absence of progressive disease or prohibitive toxicity. Receives: Drug: pyrazoloacridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate toxicity of pyrazoloacridine.
Measured: Weekly prior to each treatment cycle.
Secondary outcomes (1)
Evaluate the response frequency of pyrazoloacridine.
Measured: After 2 treatment cycles then every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2004 (estimated)
- Study startOct 1995
- Primary completionDec 2001
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Antoinette J. Wozniak, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002656
- Sponsor's protocol ID
- CDR0000064199
- Other IDs
- P30CA022453, WSU-C-1087-93, NCI-T94-0001H
- Status last verified
- Apr 2013
- First submitted
- 1 Nov 1999
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CARCINOMA
- ClinicalTrials.gov ID
- NCT00002656
- Acronym / sponsor ID
- CDR0000064199
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 1995
- Primary completion
- Dec 2001 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 10 Jun 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrazoloacridine | Experimental | Drug: pyrazoloacridinePyrazoloacridine 750 mg/m2 by 3 hour infusion, every 21 day s in the absence of progressive disease or prohibitive toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pyrazoloacridinePyrazoloacridine 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) | Drug | Pyrazoloacridine |
Primary outcome
Evaluate toxicity of pyrazoloacridine.
Time frame: Weekly prior to each treatment cycle.
1 secondary outcome
Evaluate the response frequency of pyrazoloacridine.
Time frame: After 2 treatment cycles then every 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoinette J. Wozniak, MD study chair
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pyrazoloacridine in people with Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate toxicity of pyrazoloacridine. (time frame: Weekly prior to each treatment cycle.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2013.