A Phase I Study Of Tirapazamine (NSC 130181) Paclitaxel And Carboplatin With Concurrent Radiation Followed By Tirapazamine/Paclitaxel/Carboplatin Consolidation For Stage III Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Phase I Study Of Tirapazamine (NSC 130181) Paclitaxel And Carboplatin With Concurrent Radiation Followed By Tirapazamine/Paclitaxel/Carboplatin Consolidation For Stage III Non-Small Cell Lung Cancer
OBJECTIVES:
- Determine the maximum tolerated dose of tirapazamine when administered with paclitaxel,
carboplatin, and concurrent radiotherapy in patients with stage IIB-IIIB non-small cell
lung cancer.
- Determine, preliminarily, the response rate and survival of patients treated with this
regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of tirapazamine.
Patients receive induction chemotherapy comprising tirapazamine IV over 2 hours and
carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1
hour on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, and 39. Beginning on day 1, patients
undergo radiotherapy once daily 5 days a week for 6.5 weeks. Beginning 4-5 weeks after
completion of radiotherapy, patients with stable or responding disease receive consolidation
chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on
days 1 and 22.
Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed primary bronchogenic non-small cell lung
cancer
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Stage IIIA or IIIB disease (T1-4, N2-3)
- Mediastinal lymph nodes at least 2 cm in diameter by radiography sufficient to
stage N2-3 (must be node positive [cytologically or histologically confirmed] if
largest mediastinal node is less than 2 cm in diameter) OR
- Selected stage IIB disease (T3, N0 or T3, N1 with a medical condition that precludes
surgery)
- No malignant pleural effusion
- Measurable or evaluable disease by chest x-ray or CT scan
- No metastatic disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Zubrod 0-2 OR
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,500/mm^3
- Platelet count normal
Hepatic:
- Not specified
Renal:
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No uncontrolled congestive heart failure
- No unstable angina
- No unstable cardiac arrhythmias
Pulmonary:
- FEV_1 at least 1.0 L
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No clinically significant hearing loss
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for lung cancer
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for lung cancer
Surgery:
- See Disease Characteristics
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Derick H. Lau, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of California, Davis
Authority:
United States: Federal Government
Study ID:
CDR0000069281
NCT ID:
NCT00033410
Start Date:
March 2002
Completion Date:
Related Keywords:
- Lung Cancer
- stage II non-small cell lung cancer
- squamous cell lung cancer
- large cell lung cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- adenocarcinoma of the lung
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| University of California Davis Cancer Center | Sacramento, California 95817 |
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
