Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006484

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus paclitaxel with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: paclitaxel Drug: tirapazamine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Randomized Phase III Trial Of Carboplatin And Paclitaxel Plus Tirapazamine Versus Carboplatin And Paclitaxel In Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Tirapazamine Paclitaxel Carboplatin

U.S. FDA Resources

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

Study Start Date:

November 2000

Detailed Description:

OBJECTIVES:

Compare the effects of paclitaxel and carboplatin with or without tirapazamine on progression-free survival and overall survival in patients with stage IV and selected stage IIIB non-small cell lung cancer.
Compare response rates in patients treated with these regimens.
Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to weight loss (less than 5% vs 5% or more), stage of disease (IIIB vs IV), and lactate dehydrogenase level (normal vs abnormal). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive tirapazamine IV over 2 hours followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment continues every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for one year, and then every 6 months for 2 years, or until death.

PROJECTED ACCRUAL: Approximately 500 patients (250 per arm) will be accrued for this study within 20 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 proven newly diagnosed advanced primary non-small cell lung cancer (NSCLC), including the following cellular types:
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
- Unspecified carcinoma OR
Recurrent disease after prior surgery and/or radiotherapy
Stage IIIB disease
- T4 lesion due to malignant pleural effusion OR
Stage IV disease
- Any T, any N, M1 (distant metastasis, including lesions in multiple lobes of the ipsilateral lung)
Measurable or evaluable disease
- Pleural effusions, ascites, and laboratory parameters not considered as only evidence of disease
- Must be outside prior radiated field or area of prior surgical resection or new lesion must be present
No known brain metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Zubrod 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 9 g/dL

Hepatic:

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

Renal:

Creatinine no greater than ULN
Creatinine clearance at least 50 mL/min

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No peripheral neuropathy (motor or sensory) of grade 2 or greater
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I/II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior biologic therapy for NSCLC

Chemotherapy:

No prior systemic chemotherapy for NSCLC

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
At least 3 weeks since prior radiotherapy and recovered
No concurrent radiotherapy

Surgery:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006484

Show 93 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Stephen K. Williamson, MD

University of Kansas

More Information

Additional Information:

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

Publications:

Mack PC, Redman MW, Chansky K, Williamson SK, Farneth NC, Lara PN Jr, Franklin WA, Le QT, Crowley JJ, Gandara DR. Lower Osteopontin Plasma Levels Are Associated With Superior Outcomes in Advanced Non-Small-Cell Lung Cancer Patients Receiving Platinum-Based Chemotherapy: SWOG Study S0003. J Clin Oncol. 2008 Sep 8; [Epub ahead of print]

Mack PC, Redman MW, Chansky K, et al.: Elevated osteopontin (OPN) plasma levels are highly prognostic in advanced non-small cell lung cancer (NSCLC): analysis of SWOG S0003. [Abstract] J Clin Oncol 24 (Suppl 18): A-7198, 413s, 2006.

Williamson SK, Crowley JJ, Lara PN Jr, McCoy J, Lau DH, Tucker RW, Mills GM, Gandara DR; Southwest Oncology Group Trial S0003. Phase III trial of paclitaxel plus carboplatin with or without tirapazamine in advanced non-small-cell lung cancer: Southwest Oncology Group Trial S0003. J Clin Oncol. 2005 Dec 20;23(36):9097-104.

Kimura T, Holland WS, Kawaguchi T, Williamson SK, Chansky K, Crowley JJ, Doroshow JH, Lenz HJ, Gandara DR, Gumerlock PH. Mutant DNA in plasma of lung cancer patients: potential for monitoring response to therapy. Ann N Y Acad Sci. 2004 Jun;1022:55-60.

Williamson SK, Crowley JJ, Lara PN, et al.: S0003: paclitaxel/carboplatin (PC) versus PC + tirapazamine (PCT) in advanced non-small cell lung cancer (NSCLC). A phase III Southwest Oncology Group (SWOG) trial. [Abstract] Lung Cancer 41 (Suppl 2): A-O-89, S29, 2003.

Lara PN Jr, Redman MW, Kelly K, Edelman MJ, Williamson SK, Crowley JJ, Gandara DR; Southwest Oncology Group. Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: results from Southwest Oncology Group randomized trials. J Clin Oncol. 2008 Jan 20;26(3):463-7.

Gandara DR, Kawaguchi T, Crowley JJ, et al.: Pharmacogenomic (PG) analysis of Japan-SWOG common arm study in advanced stage non-small cell lung cancer (NSCLC): a model for testing population-related pharmacogenomics. [Abstract] J Clin Oncol 25 (Suppl 18): A-7500, 2007.

Lara PN Jr, Redman MW, Kelly K, et al.: Alternative measures predicting clinical benefit in advanced non-small cell lung cancer (NSCLC) from Southwest Oncology Group (SWOG) randomized trials: implications for clinical trial design. [Abstract] J Clin Oncol 24 (Suppl 18): A-7006, 365s, 2006.

Study ID Numbers:	CDR0000068315, SWOG-S0003
Study First Received:	November 6, 2000
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00006484 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer

stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung

Study placed in the following topic categories:

Thoracic Neoplasms
Antimitotic Agents
Carboplatin
Recurrence
Carcinoma
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel

Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Tirapazamine
Adenocarcinoma of Lung
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Tirapazamine
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009