Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.
2. Determine, preliminarily, the response rate and survival of patients treated with this regimen.
3. Determine the toxicity of this regimen in these patients.

Entry 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

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

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/mm³
• 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:

• FEV₁ at least 1.0 L

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No clinically significant hearing loss

Expected Enrollment

Approximately 3-30 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

California Cancer Consortium

Derick Lau, MD, Protocol chair		Ph: 916-734-3772

Registry Information
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
Trial Start Date		2002-03-29
Registered in ClinicalTrials.gov		NCT00033410
Date Submitted to PDQ		2002-02-08
Information Last Verified		2006-09-17
NCI Grant/Contract Number		CA33572, CA62505

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