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

Sponsor:	Southwest Oncology Group
Collaborator:	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 Radiation: radiation therapy	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Tirapazamine Etoposide Etoposide phosphate

U.S. FDA Resources

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
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

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

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

Additional Information:

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

Publications:

Le QT, Moon J, Redman M, Williamson SK, Lara PN Jr, Goldberg Z, Gaspar LE, Crowley JJ, Moore DF Jr, Gandara DR. Phase II Study of Tirapazamine, Cisplatin, and Etoposide and Concurrent Thoracic Radiotherapy for Limited-Stage Small-Cell Lung Cancer: SWOG 0222. J Clin Oncol. 2009 Apr 13; [Epub ahead of print]

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
Study First Received:	August 6, 2003
Last Updated:	April 18, 2009
ClinicalTrials.gov Identifier:	NCT00066742 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

limited stage small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Etoposide phosphate
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Tirapazamine
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009