Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00087802

Collaborator

(none)

383

Enrollment

Locations

Arms

5.5

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC).

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung	Drug: gemcitabine/Eloxatin (GEMOX) Drug: carboplatin/paclitaxel (CP)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

383 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) Versus Carboplatin/Paclitaxel (CP) as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stratum 1 Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease). Randomization schedules will be produced for each stratum, and treatment allocation will be carried out centrally	Drug: gemcitabine/Eloxatin (GEMOX) GEMOX [gemcitabine/Eloxatin™ (Oxaliplatin) - 21 day cycle] Gemcitabine 1000 mg/m2 will be administered over 30 minutes on Days 1 and 8 and Eloxatin™ 130 mg/m2 will be administered over 2 hours on Day 1, after gemcitabine administration, every 21 days [3-week cycle]
Active Comparator: Stratum 2 Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease).	Drug: carboplatin/paclitaxel (CP) CP [carboplatin/paclitaxel - 21 day cycle] o Paclitaxel 225 mg/m2 will be administered over 3 hours on Day 1 followed by carboplatin at a dose calculated to produce an area under the concentration-time curve (AUC) of 6.0 over 30-60 minutes on Day 1 every 21 days [3-week cycle]

Arm

Intervention/Treatment

Active Comparator: Stratum 1

Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease). Randomization schedules will be produced for each stratum, and treatment allocation will be carried out centrally

Drug: gemcitabine/Eloxatin (GEMOX)

GEMOX [gemcitabine/Eloxatin™ (Oxaliplatin) - 21 day cycle] Gemcitabine 1000 mg/m2 will be administered over 30 minutes on Days 1 and 8 and Eloxatin™ 130 mg/m2 will be administered over 2 hours on Day 1, after gemcitabine administration, every 21 days [3-week cycle]

Active Comparator: Stratum 2

Drug: carboplatin/paclitaxel (CP)

CP [carboplatin/paclitaxel - 21 day cycle] o Paclitaxel 225 mg/m2 will be administered over 3 hours on Day 1 followed by carboplatin at a dose calculated to produce an area under the concentration-time curve (AUC) of 6.0 over 30-60 minutes on Day 1 every 21 days [3-week cycle]

Outcome Measures

Primary Outcome Measures

To determine the relative efficacy, safety and clinical benefit of the GEMOX regimen compared to the standard combination regimen of CP as first-line treatment of Stage IIIB and IV NSCLC [22 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive
One (1) unidimensionally measurable lesion
ECOG Performance Status of 0 or 1, no peripheral neuropathy >Grade 1
Patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. Patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment.
Recovery in full from any previous surgical procedure
No history of an acute cardiac or CNS event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease

Exclusion Criteria:

Hypersensitivity to any of the 4 study drugs
Concurrent immunotherapy or participation in any investigational drug study within 4 weeks
Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft
History of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder)
Patient is a pregnant or lactating female

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama	United States	35235
2	Birmingham Hematology and Oncology Associates	Birmingham	Alabama	United States	35235
3	Hematology Oncology Associates	Phoenix	Arizona	United States	85012
4	Northern Arizona Hematology & Oncology Associates	Sedona	Arizona	United States	86336
5	Arizona Oncology Associates - Hematology Oncology Physicians	Tucson	Arizona	United States	85704
6	Rocky Mountain Cancer Centers	Denver	Colorado	United States	80218
7	Florida Cancer Institute	New Port Richey	Florida	United States	34652
8	Ocala Oncology Center	Ocala	Florida	United States	34474
9	Cancer Centers of Florida, P.A.	Ocoee	Florida	United States	34761
10	South Florida Oncology & Hematology Consultants	Plantation	Florida	United States	33324
11	Hematology Oncology Associates of Illinois	Chicago	Illinois	United States	60611
12	Northwest Medical Specialists, PC	Niles	Illinois	United States	60714
13	Hematology Oncology Associates of Illinois	Skokie	Illinois	United States	60077
14	Central Indiana Cancer Centers	Indianapolis	Indiana	United States	46227
15	Oncology Associates of Cedar Rapids	Cedar Rapids	Iowa	United States	52403
16	Kansas City Oncology and Hematology Group	Overland Park	Kansas	United States	66210
17	Maryland Oncology Hematology, P.A.	Columbia	Maryland	United States	21044
18	Berkshire Hematology Oncology, PC	Pittsfield	Massachusetts	United States	01201
19	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota	United States	55404
20	Minnesota Oncology Hematology	Minneapolis	Minnesota	United States	55404
21	Missouri Cancer Associates	Columbia	Missouri	United States	65201
22	Arch Medical Services, Inc.	St. Louis	Missouri	United States	63141
23	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada	United States	89109
24	New Mexico Cancer Care Associates	Santa Fe	New Mexico	United States	87505
25	New York Oncology Hematology, P.C.	Albany	New York	United States	12208
26	New York Oncology Hematology	Latham	New York	United States	12110
27	New York Oncology Hematology, P.C.	Rexford	New York	United States	12148
28	Interlakes Oncology & Hematology, P.C.	Rochester	New York	United States	14623
29	Raleigh Hematology Oncology Clinic	Cary	North Carolina	United States	27511
30	Piedmont Hematology Oncology Associates, PLLC.	Winston-Salem	North Carolina	United States	27103
31	Dayton Oncology & Hematology, P.A.	Kettering	Ohio	United States	45409
32	Cancer Care Associates	Oklahoma City	Oklahoma	United States	73120
33	Cancer Care Associates	Tulsa	Oklahoma	United States	74136-1902
34	Willamette Valley Cancer Center	Eugene	Oregon	United States	97401
35	Cancer Centers of the Carolinas	Seneca	South Carolina	United States	29672
36	Texas Cancer Center - Abilene	Abilene	Texas	United States	79606
37	Texas Oncology, P.A.	Arlington	Texas	United States	76012
38	Texas Oncology Cancer Center	Austin	Texas	United States	78731
39	Mamie McFaddin Ward Cancer Center	Beaumont	Texas	United States	77702-1449
40	Texas Oncology, P.A.	Bedford	Texas	United States	76022
41	Texas Cancer Center at Medical City	Dallas	Texas	United States	75230-2510
42	Texas Oncology, P.A.	Dallas	Texas	United States	75231
43	The Texas Cancer Center	Dallas	Texas	United States	75237
44	Texas Oncology, P.A.	Dallas	Texas	United States	75246
45	Texas Cancer Center - Denton	Denton	Texas	United States	76210
46	El Paso Cancer Treatment Ctr-East	El Paso	Texas	United States	79915
47	Texas Oncology, P.A.	Fort Worth	Texas	United States	76104
48	San Antonio Tumor and Blood Clinic	Fredericksburg	Texas	United States	78624
49	Texas Oncology, P.A.	Garland	Texas	United States	75042-5788
50	Texas Oncology, P.A.	Houston	Texas	United States	77024
51	Texas Oncology, P.A.	Irving	Texas	United States	75061-2244
52	Lake Vista Cancer Center	Lewisville	Texas	United States	75067
53	Longview Cancer Center	Longview	Texas	United States	75601
54	South Texas Cancer Center - McAllen	McAllen	Texas	United States	78503-1298
55	Texas Cancer Center of Mesquite	Mesquite	Texas	United States	75150
56	Allison Cancer Center	Midland	Texas	United States	79701-5946
57	West Texas Cancer Center	Odessa	Texas	United States	79761
58	Paris Regional Cancer Center	Paris	Texas	United States	75460
59	Hematology Oncology Associates of South Texas	San Antonio	Texas	United States	78229
60	Texas Cancer Center - Sherman	Sherman	Texas	United States	75090-0504
61	Tyler Cancer Center	Tyler	Texas	United States	75702
62	Waco Cancer Care and Research Center	Waco	Texas	United States	76712
63	Deke Slayton Cancer Center	Webster	Texas	United States	77598
64	Fairfax Northern Virginia Hematology Oncology, PC	Fairfax	Virginia	United States	22031
65	Virginia Oncology Associates	Norfolk	Virginia	United States	23502
66	Oncology & Hematology Associates of Southwest Virginia, Inc.	Salem	Virginia	United States	24153
67	Puget Sound Cancer Centers	Edmonds	Washington	United States	98026
68	Puget Sound Cancer Centers	Seattle	Washington	United States	98133
69	Cancer Care Northwest	Spokane	Washington	United States	99218
70	Northwest Cancer Specialists, P.C.	Vancouver	Washington	United States	98684