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Tirapazamine Combined With Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066742
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in 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 chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy with tirapazamine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Drug: tirapazamine
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Etoposide    Cisplatin    Etoposide phosphate    Tirapazamine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study Of Tirapazamine (NSC-130181)/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Measurability of lesions [ Designated as safety issue: No ]
  • Objective response [ Designated as safety issue: No ]
  • Best response [ Designated as safety issue: No ]
  • Performance status [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment:   85
Study Start Date:   September 2003

Detailed Description:

OBJECTIVES:

  • Determine the overall survival of patients with limited stage small cell lung cancer treated with tirapazamine, cisplatin, and etoposide with concurrent thoracic radiotherapy followed by consolidation cisplatin and etoposide.
  • Determine the time to treatment failure and response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Correlate baseline PAI-1, VEGF, OPN, and NDRG1 plasma markers with response and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Chemoradiotherapy: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks.
  • Consolidation chemotherapy: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 30-85 patients will be accrued for this study within 17 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed limited stage small cell lung cancer (SCLC)

    • Diagnosis by sputum cytology is allowed provided there is pathologic confirmation of disease
    • No positron-emission tomography scans for tumor staging
  • Measurable or non-measurable disease by CT scan, MRI, or x-ray

    • Disease must be present outside the area of any prior surgical resection
  • No metastatic disease, including brain metastases
  • No malignant pericardial or pleural effusion*, defined as 1 of the following:

    • Cytologically positive effusion
    • Exudative effusion not attributable to other etiologies NOTE: *Patients with effusions too small to tap are eligible
  • Patients must be offered participation in SWOG-S9925

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2 times ULN

Renal

  • Creatinine clearance at least 50 mL/min* NOTE: *If calculated creatinine clearance is used, creatinine must be < 1.5 mg/dL

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Patients with significant clinical hearing loss must be willing to accept the potential for worsening of symptoms
  • No grade 1 or greater symptomatic sensory neuropathy
  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for SCLC
  • No concurrent filgrastim (G-CSF) during radiotherapy administration

Chemotherapy

  • No prior chemotherapy for SCLC

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior thoracic or neck radiotherapy
  • No concurrent intensity-modulated radiotherapy

Surgery

  • See Disease Characteristics
  • At least 2 weeks since prior thoracic or major surgery and recovered

Other

  • No concurrent amifostine
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066742

Show 134 study locations  Show 134 Study Locations

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Quynh-Thu X. Le, MD     Stanford University    
Investigator:     Stephen K. Williamson, MD     University of Kansas    
Investigator:     Primo N. Lara, MD     University of California, Davis    
Investigator:     Zelanna Goldberg, MD     University of California, Davis    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Le Q, Moon J, Redman M, et al.: SWOG 0222: A phase II study of tirapazamine (NSC-130181, TPZ)/cisplatin/etoposide (PE) and concurrent thoracic radiotherapy (TRT) for limited stage small-cell lung cancer (LSCLC). [Abstract] J Clin Oncol 26 (Suppl 15): A-7523, 2008.
 

Study ID Numbers:   CDR0000318805, SWOG-S0222
First Received:   August 6, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00066742
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
limited stage small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Tirapazamine
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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