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A Phase II Study Of Tirapazamine (NSC-130181)/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

A Phase II Study Of Tirapazamine (NSC-130181)/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer


I. 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.

II. Determine the time to treatment failure and response (confirmed and unconfirmed,
complete and partial) in patients with measurable disease treated with this regimen.

III. Determine the toxicity of this regimen in these patients. IV. Correlate baseline PAI-1,
VEGF, OPN, and NDRG1 plasma markers with response and survival of patients treated with this

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

Inclusion Criteria


- 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



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2 times ULN


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


- 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


Biologic therapy

- No prior biologic therapy for SCLC

- No concurrent filgrastim (G-CSF) during radiotherapy administration


- No prior chemotherapy for SCLC

Endocrine therapy

- Not specified


- No prior thoracic or neck radiotherapy

- No concurrent intensity-modulated radiotherapy


- See Disease Characteristics

- At least 2 weeks since prior thoracic or major surgery and recovered


- No concurrent amifostine

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.

Outcome Time Frame:

Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.

Safety Issue:


Principal Investigator

Quynh-Thu X. Le, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University


United States: Federal Government

Study ID:




Start Date:

September 2003

Completion Date:

August 2009

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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