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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00033410
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: paclitaxel Drug: tirapazamine Radiation: radiation therapy Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Primary Purpose: Treatment
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 Start Date : March 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Zubrod 0-2 OR
  • ECOG 0-2

Life expectancy:

  • Not specified


  • WBC at least 3,500/mm^3
  • Platelet count normal


  • Not specified


  • Creatinine clearance at least 60 mL/min


  • No uncontrolled congestive heart failure
  • No unstable angina
  • No unstable cardiac arrhythmias


  • FEV_1 at least 1.0 L


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


Biologic therapy:

  • Not specified


  • No prior chemotherapy for lung cancer

Endocrine therapy:

  • Not specified


  • No prior radiotherapy for lung cancer


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00033410

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
California Cancer Consortium
National Cancer Institute (NCI)
Study Chair: Derick H. Lau, MD University of California, Davis Identifier: NCT00033410     History of Changes
Other Study ID Numbers: CDR0000069281
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: September 2006

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action