ZPACT: Non-small Cell Lung Cancer Study US75 (Z-PACT)

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00086268

Collaborator

(none)

250

Enrollment

Locations

Arms

Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Carcinoma	Drug: zoledronic acid Drug: Taxotere Drug: Carboplatin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Zometa® 4mg monthly for 12 months from date of first chemotherapy dose	Drug: zoledronic acid Drug: Taxotere Drug: Carboplatin
No Intervention: no further treatment Control arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose

Arm

Intervention/Treatment

Experimental: Zometa®

4mg monthly for 12 months from date of first chemotherapy dose

Drug: zoledronic acid

Drug: Taxotere

Drug: Carboplatin

No Intervention: no further treatment

Control arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or Female patients at least of 18 years old
Patients with diagnosed non-small cell lung cancer that cannot be treated by surgery
Women must not be pregnant or attempting to become pregnant
Able and willing to sign informed consent

Exclusion Criteria:

Patients with cancer that has spread to the bone
Patients with cancer that has spread to the brain who are receiving treatment
Patients with kidney disease
Patients treated with other investigational drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Consultants	Hoover	Alabama	United States	35216
2	Arizona Oncology Assoc.	Tucson	Arizona	United States	85715
3	NEA Clinic	Jonesboro	Arkansas	United States	72401
4	Highlands Oncology Group	Springdale	Arkansas	United States	72764
5	NorthBay Cancer Center	Fairfield	California	United States	94533
6	UCLA	Los Angeles	California	United States	91401
7	Clinical Trials and Research Associates, Inc.	Montebello	California	United States	90640
8	Med. Oncology Care Associates	Orange	California	United States	92868
9	Cancer Center of Santa Barbara	Santa Barbara	California	United States	93105
10	Cancer Center of Colorado Springs	Colorado Springs	Colorado	United States	80907
11	Northern Hematology-Oncology	Thornton	Colorado	United States	80260
12	Lynn Regional Cancer Center	Boca Raton	Florida	United States	33428
13	New Hope Cancer Centers	Hudson	Florida	United States	34667
14	Oceola Cancer Center	Kissimmee	Florida	United States	34741
15	Innovative Medical Research of South Florida, Inc.	Miami Shores	Florida	United States	33138
16	VA Medical Center	Miami	Florida	United States	33125
17	NCH Healthcare System Oncology Research	Naples	Florida	United States	34102
18	Metcare Oncology	Ormond Beach	Florida	United States	32174
19	Hematology-Oncology Associates	Pensacola	Florida	United States	32501
20	AMIT SHAH Medical Group	Sebring	Florida	United States	33872
21	Peachtree Hematology & Oncology	Atlanta	Georgia	United States	30309
22	Emory University	Atlanta	Georgia	United States	30322
23	Straub Clinic & Hospital	Honolulu	Hawaii	United States	96813
24	Kaiser Foundation Hospital	Honolulu	Hawaii	United States	96819
25	Advocate Illinois Masonic Medical Center Creticos Cancer Center	Chicago	Illinois	United States	60657
26	OSF Center for Cancer Care	Rockford	Illinois	United States	61108
27	Springfield Clinic, LLP	Springfield	Illinois	United States	62703
28	Central Indiana Cancer Centers	Indianapolis	Indiana	United States	46219
29	Oncology Institute of Greater Lafayette	Lafayette	Indiana	United States	47904
30	Community Hospital, Cancer Research Dept.	Munster	Indiana	United States	46321
31	Northern Indiana Oncology Associates	South Bend	Indiana	United States	46617
32	Cedar Valley Medical Specialists	Waterloo	Iowa	United States	50702
33	Kansas City Cancer Ctr. South	Lenexa	Kansas	United States	66214
34	Hematology/Oncology Clinic	Baton Rouge	Louisiana	United States	70808
35	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana	United States	70809
36	LSU Health Sciences Center	Shreveport	Louisiana	United States	71103
37	Maine Center for Cancer Medicine	Scarborough	Maine	United States	04074
38	Oncology Care Associates	Bethesda	Maryland	United States	20817
39	Berkshire Hematology Oncology PC	Pittsfield	Massachusetts	United States	01201
40	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
41	Kalamazoo Hematology & Oncology	Kalamazoo	Michigan	United States	49048
42	Mitchell Folbe, MD, PC	Troy	Michigan	United States	48085
43	Park Nicollett Institute	Saint Louis Park	Minnesota	United States	55416
44	St. Louis Cancer Care	Chesterfield	Missouri	United States	63017
45	Southeast Nebraska Cancer Center	Lincoln	Nebraska	United States	68510
46	Odyssey Research	Scottsbluff	Nebraska	United States	69361
47	Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
48	Nevada Cancer Center	Las Vegas	Nevada	United States	89109
49	East Orange VA Medical System	East Orange	New Jersey	United States	07018
50	Howell Office Plaza	Howell	New Jersey	United States	07731
51	Atlantic Hem Onc Associates, LLC	Manasquan	New Jersey	United States	08736
52	Hematology/Oncology Assoc. of South Jersey	Mount Holly	New Jersey	United States	08060
53	Cancer Institute of New Jersey at Cooper University Hospital	Voorhees	New Jersey	United States	08043
54	New Mexico Oncology Hematology Consultants, Ltd.	Albuquerque	New Mexico	United States	87109
55	San Juan Regional Cancer Ctr.	Farmington	New Mexico	United States	87401
56	New Mexico Cancer Care Associates	Santa Fe	New Mexico	United States	87505
57	Engracio Cortes, MD	Bayside	New York	United States	11361
58	Arena Oncology Assoc.	Great Neck	New York	United States	11021
59	James P. Wilmot Cancer Center	Rochester	New York	United States	16642
60	SUNY Upstate Medical University	Syracuse	New York	United States	13210
61	Syracuse VA Medical Center	Syracuse	New York	United States	13210
62	Presbyterian Hospital	Charlotte	North Carolina	United States	28204
63	Southern Oncology Research	Grifton	North Carolina	United States	28530
64	Barberton Citizens Hospital-Cancer Center	Barberton	Ohio	United States	44203
65	Dayton Clinical Oncology Program	Dayton	Ohio	United States	45429
66	Forum Health Cancer CareCenter	Youngstown	Ohio	United States	44501
67	Cancer Specialists of Oklahoma	Oklahoma City	Oklahoma	United States	73112
68	Hematology Oncology Associates	Medford	Oregon	United States	97504
69	Charleston Hematology Oncology	Charleston	South Carolina	United States	29403
70	Charleston Cancer Center	Charleston	South Carolina	United States	29406
71	Liberty Hematology-Oncology	Columbia	South Carolina	United States	29203
72	Santee Hematology/Oncology	Sumter	South Carolina	United States	29150
73	The Jones Clinic	Germantown	Tennessee	United States	38138
74	Knoxville Cancer Center	Knoxville	Tennessee	United States	27909
75	Cancer Specialists of South Texas	Corpus Christi	Texas	United States	78412
76	Blood and Cancer Center of East Texas	Tyler	Texas	United States	75701
77	Tyler Hematology Oncology, PA	Tyler	Texas	United States	75701
78	Odyssey Research	Belle Haven	Virginia	United States	23306
79	Masoom Kandahari, MD	Woodbridge	Virginia	United States	22191
80	West Virginia University	Morgantown	West Virginia	United States	26506