Pyrazoloacridine in Treating Patients With Advanced Non-small Cell Lung Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: pyrazoloacridine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CARCINOMA |
- Evaluate toxicity of pyrazoloacridine. [ Time Frame: Weekly prior to each treatment cycle. ] [ Designated as safety issue: Yes ]
- Evaluate the response frequency of pyrazoloacridine. [ Time Frame: After 2 treatment cycles then every 2 months ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | October 1995 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | December 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Study Chair: | Antoinette J. Wozniak, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002656 History of Changes |
| Other Study ID Numbers: | CDR0000064199, P30CA022453, WSU-C-1087-93, NCI-T94-0001H |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 25, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases NSC 366140 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013