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

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI SWOG-S0222 S0222, NCT00066742

Objectives

1. 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.
2. Determine the time to treatment failure and response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with this regimen.
3. Determine the toxicity of this regimen in these patients.
4. Correlate baseline PAI-1, VEGF, OPN, and NDRG1 plasma markers with response and survival of patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

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

Outcomes

Measurability of lesions
Objective response
Best response
Performance status
Time to treatment failure
Survival

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.

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Quynh-Thu Le, MD, Protocol chair		Ph: 650-498-5032
Stephen Williamson, MD, Protocol co-chair		Ph: 913-588-6029 Email: swilliam@kumc.edu
Primo Lara, MD, Protocol co-chair		Ph: 916-734-3771
Zelanna Goldberg, MD, Protocol co-chair		Ph: 916-734-8172

Registry Information
Official Title		A Phase II Study Of Tirapazamine (NSC-130181)/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer
Trial Start Date		2003-09-01
Registered in ClinicalTrials.gov		NCT00066742
Date Submitted to PDQ		2003-07-01
Information Last Verified		2006-08-01
NCI Grant/Contract Number		CA32102

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