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Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
carboplatin
paclitaxel
tirapazamine
radiation therapy
Sponsored by
California Cancer Consortium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • University of California Davis Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 9, 2002
Last Updated
February 6, 2009
Sponsor
California Cancer Consortium
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00033410
Brief Title
Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
California Cancer Consortium
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tirapazamine may make the tumor cells more sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and tirapazamine may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with tirapazamine and radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
tirapazamine
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derick H. Lau, MD
Organizational Affiliation
University of California, Davis
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

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Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

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