Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00006484
• Collaborator: National Cancer Institute (NCI) (NIH)
• Locations: 93
• Duration (Months): 65

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin; Drug: paclitaxel; Drug: tirapazamine	Phase 3

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2000
• Actual Study Completion Date: Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36688
2	CCOP - Greater Phoenix	Phoenix	Arizona	United States	85006-2726
3	Veterans Affairs Medical Center - Phoenix (Hayden)	Phoenix	Arizona	United States	85012
4	Veterans Affairs Medical Center - Tucson	Tucson	Arizona	United States	85723
5	Arizona Cancer Center	Tucson	Arizona	United States	85724
6	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
7	Veterans Affairs Medical Center - Little Rock (McClellan)	Little Rock	Arkansas	United States	72205
8	Cancer Center and Beckman Research Institute, City of Hope	Duarte	California	United States	91010-3000
9	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90033-0804
10	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California	United States	90095-1781
11	Veterans Affairs Outpatient Clinic - Martinez	Martinez	California	United States	94553
12	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609-3305
13	Chao Family Comprehensive Cancer Center	Orange	California	United States	92868
14	University of California Davis Cancer Center	Sacramento	California	United States	95817
15	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94143-0128
16	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California	United States	95403
17	David Grant Medical Center	Travis Air Force Base	California	United States	94535
18	University of Colorado Cancer Center	Denver	Colorado	United States	80010
19	Veterans Affairs Medical Center - Denver	Denver	Colorado	United States	80220
20	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342-1701
21	Dwight David Eisenhower Army Medical Center	Fort Gordon	Georgia	United States	30905-5650
22	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
23	MBCCOP - University of Illinois at Chicago	Chicago	Illinois	United States	60612-7323
24	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
25	CCOP - Central Illinois	Decatur	Illinois	United States	62526
26	Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)	Hines	Illinois	United States	60141
27	Loyola University Medical Center	Maywood	Illinois	United States	60153
28	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa	United States	52722
29	University of Kansas Medical Center	Kansas City	Kansas	United States	66160-7357
30	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
31	Veterans Affairs Medical Center - Wichita	Wichita	Kansas	United States	67218
32	Veterans Affairs Medical Center - Lexington	Lexington	Kentucky	United States	40511-1093
33	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky	United States	40536-0084
34	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
35	Tulane University School of Medicine	New Orleans	Louisiana	United States	70112
36	Louisiana State University Health Sciences Center - Shreveport	Shreveport	Louisiana	United States	71130-3932
37	Veterans Affairs Medical Center - Shreveport	Shreveport	Louisiana	United States	71130
38	Boston Medical Center	Boston	Massachusetts	United States	02118
39	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts	United States	02130
40	Veterans Affairs Medical Center - Ann Arbor	Ann Arbor	Michigan	United States	48105
41	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
42	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0752
43	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	United States	48201-1379
44	Veterans Affairs Medical Center - Detroit	Detroit	Michigan	United States	48201-1932
45	Henry Ford Hospital	Detroit	Michigan	United States	48202
46	Providence Hospital - Southfield	Southfield	Michigan	United States	48075-9975
47	CCOP - Duluth	Duluth	Minnesota	United States	55805
48	Veterans Affairs Medical Center - Biloxi	Biloxi	Mississippi	United States	39531-2410
49	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
50	Veterans Affairs Medical Center - Jackson	Jackson	Mississippi	United States	39216
51	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi	United States	39534-2576
52	Veterans Affairs Medical Center - Kansas City	Kansas City	Missouri	United States	64128
53	CCOP - Kansas City	Kansas City	Missouri	United States	64131
54	St. Louis University Health Sciences Center	Saint Louis	Missouri	United States	63110-0250
55	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
56	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65807
57	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
58	Veterans Affairs Medical Center - Albuquerque	Albuquerque	New Mexico	United States	87108-5138
59	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
60	Veterans Affairs Medical Center - Albany	Albany	New York	United States	12208
61	Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
62	University of Rochester Medical Center	Rochester	New York	United States	14642
63	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
64	Veterans Affairs Medical Center - Cincinnati	Cincinnati	Ohio	United States	45220-2288
65	Barrett Cancer Center, The University Hospital	Cincinnati	Ohio	United States	45267-0502
66	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
67	CCOP - Columbus	Columbus	Ohio	United States	43206
68	Veterans Affairs Medical Center - Dayton	Dayton	Ohio	United States	45428
69	CCOP - Dayton	Kettering	Ohio	United States	45429
70	CCOP - Toledo Community Hospital Oncology Program	Toledo	Ohio	United States	43623-3456
71	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma	United States	73104
72	Veterans Affairs Medical Center - Oklahoma City	Oklahoma City	Oklahoma	United States	73104
73	Oregon Cancer Center	Portland	Oregon	United States	97201-3098
74	Veterans Affairs Medical Center - Portland	Portland	Oregon	United States	97207
75	CCOP - Columbia River Program	Portland	Oregon	United States	97213
76	Veterans Affairs Medical Center - Charleston	Charleston	South Carolina	United States	29401-5799
77	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0721
78	CCOP - Greenville	Greenville	South Carolina	United States	29615
79	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
80	Brooke Army Medical Center	Fort Sam Houston	Texas	United States	78234
81	University of Texas Medical Branch	Galveston	Texas	United States	77555-0209
82	Veterans Affairs Medical Center - Houston	Houston	Texas	United States	77030
83	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7811
84	Veterans Affairs Medical Center - San Antonio (Murphy)	San Antonio	Texas	United States	78284
85	Veterans Affairs Medical Center - Temple	Temple	Texas	United States	76504
86	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
87	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
88	Veterans Affairs Medical Center - Salt Lake City	Salt Lake City	Utah	United States	84148
89	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
90	Swedish Cancer Institute	Seattle	Washington	United States	98104
91	Veterans Affairs Medical Center - Seattle	Seattle	Washington	United States	98108
92	CCOP - Northwest	Tacoma	Washington	United States	98405-0986
93	Madigan Army Medical Center	Tacoma	Washington	United States	98431-5000

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Stephen K. Williamson, MD, University of Kansas

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gandara DR, Kawaguchi T, Crowley J, Moon J, Furuse K, Kawahara M, Teramukai S, Ohe Y, Kubota K, Williamson SK, Gautschi O, Lenz HJ, McLeod HL, Lara PN Jr, Coltman CA Jr, Fukuoka M, Saijo N, Fukushima M, Mack PC. Japanese-US common-arm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a model for assessing population-related pharmacogenomics. J Clin Oncol. 2009 Jul 20;27(21):3540-6. doi: 10.1200/JCO.2008.20.8793. Epub 2009 May 26.
• 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. doi: 10.1200/JCO.2007.13.0344.
• 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.

• ClinicalTrials.gov Identifier: NCT00006484
• Other Study ID Numbers: CDR0000068315; SWOG-S0003
• First Posted: Jun 2, 2003
• Last Update Posted: Jun 24, 2013
• Last Verified: Jan 1, 2002

• Keywords provided by , ,: 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
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Paclitaxel; Carboplatin; Tirapazamine

Study Results

No Results Posted as of Jun 24, 2013