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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

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

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. 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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Quynh-Thu X. Le, MD
  • Stephen K. Williamson, MD
  • Primo N. Lara, MD
  • Zelanna Goldberg, MD
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • cisplatin
  • etoposide
  • tirapazamine
Radiation
  • radiation therapy
Physician Researcher

Investigator Name:

  • Quynh-Thu X. Le, MD
  • Stephen K. Williamson, MD
  • Primo N. Lara, MD
  • Zelanna Goldberg, MD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 2
Trial ID: NCT00066742
Volunteers:  Not Accepting Healthy Volunteers

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