A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00035035

Collaborator

(none)

115

Locations

Study Details

Study Description

Brief Summary

Definition: This study will compare the drug GEMZAR to a combination of GEMZAR plus ALIMTA for the treatment of cancer of the pancreas. Patients may be able to participate in this study if they have cancer in their pancreas that cannot be removed by surgery OR that has spread to a new site in their body.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms Metastases, Neoplasm	Drug: GEMZAR Drug: ALIMTA	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 3 Trial of ALIMTA (LY231514, Pemetrexed) Plus GEMZAR Versus GEMZAR in Patients With Unresectable or Metastatic Cancer of the Pancreas.

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:

Pancreas cancer that cannot be removed by surgery OR that has spread to a new site in your body.
You must have one tumor that can be physically measured or scanned by the doctor.
You have not had any chemotherapy, immunotherapy, biologic therapy, or hormonal therapy for pancreas cancer, including 5-FU.
You cannot have any radiation for 4 weeks before starting this study, and you cannot have radiation to the whole pelvis.

Exclusion Criteria:

Treatment with any medication or device that has not been approved by regulatory agencies, like the FDA, at the time you enter the study.
Documentation that the cancer has spread to your brain.
Pregnant or breastfeeding.
A second primary cancer.
Unable to stop aspirin or non-steroidal anti-inflammatory agents (like ibuprofen) for 5-8 days.

Contacts and Locations

Locations

	City	State	Country
1	Huntsville	Alabama	United States
2	Fountain Valley	California	United States
3	Fullerton	California	United States
4	Lancaster	California	United States
5	Los Angeles	California	United States
6	Pomona	California	United States
7	Santa Rosa	California	United States
8	Torrance	California	United States
9	Fort Collins	Colorado	United States
10	Hartford	Connecticut	United States
11	Lake Worth	Florida	United States
12	Miami	Florida	United States
13	Chicago	Illinois	United States
14	Decatur	Illinois	United States
15	Harvey	Illinois	United States
16	Indianapolis	Indiana	United States
17	Wichita	Kansas	United States
18	Crestview Hills	Kentucky	United States
19	Louisville	Kentucky	United States
20	Lafayette	Louisiana	United States
21	Shreveport	Louisiana	United States
22	Scarborough	Maine	United States
23	Burlington	Massachusetts	United States
24	Omaha	Nebraska	United States
25	Albuquerque	New Mexico	United States
26	New York	New York	United States
27	Canton	Ohio	United States
28	Cleveland	Ohio	United States
29	Drexel Hill	Pennsylvania	United States
30	Pittsburgh	Pennsylvania	United States
31	Charleston	South Carolina	United States
32	Columbia	South Carolina	United States
33	Johnson City	Tennessee	United States
34	Memphis	Tennessee	United States
35	Nashville	Tennessee	United States
36	San Antonio	Texas	United States
37	Tyler	Texas	United States
38	Tacoma	Washington	United States
39	Marshfield	Wisconsin	United States
40	Milwaukee	Wisconsin	United States
41	Capitol Federal	Buenos Aires	Argentina
42	Santa Fe	Rosario	Argentina
43	Ciudad De Buenos Aires		Argentina
44	Mendoza		Argentina
45	Bankstown	New South Wales	Australia
46	Kingswood Penrith	New South Wales	Australia
47	Wollongong	New South Wales	Australia
48	Southport	Queensland	Australia
49	Fitzroy	Victoria	Australia
50	Frankston	Victoria	Australia
51	Innsbruck		Austria
52	St. Veit Glan		Austria
53	Wien		Austria
54	Brussels		Belgium
55	Gent		Belgium
56	Leuven		Belgium
57	Cali		Colombia
58	Strasbourg	Cedex	France
59	Lille Cedex		France
60	Marseille		France
61	Paris Cedex 10		France
62	Paris Cedex 13		France
63	Rennes Cedex		France
64	Rouen Cedex		France
65	Toulouse Cedex		France
66	Bielefeld	Nordhein-Westfalen	Germany
67	Berlin		Germany
68	Bremerhaven		Germany
69	Frankfurt		Germany
70	Kaiserslautern		Germany
71	Karlsruhe		Germany
72	Magdeburg		Germany
73	Mannheim		Germany
74	Munchen		Germany
75	Neustadt/Suedharz		Germany
76	Stuttgart		Germany
77	Maroussi	Athens	Greece
78	Ioannina		Greece
79	Genova		Italy
80	Ravenna		Italy
81	Roma		Italy
82	Breda		Netherlands
83	Den Haag		Netherlands
84	Enschede		Netherlands
85	Roermond		Netherlands
86	Sittard		Netherlands
87	Chiclayo		Peru
88	Lima		Peru
89	Lisboa		Portugal
90	Porto		Portugal
91	Santa Maria Da Feira		Portugal
92	Santarem		Portugal
93	Elche	Alicante	Spain
94	Barcelona		Spain
95	Madrid		Spain
96	Santa Cruz De Tenerife		Spain
97	Zaragoza		Spain
98	Linkoping		Sweden
99	Lund		Sweden
100	Malmo		Sweden
101	Stockholm		Sweden
102	Umea		Sweden
103	Tao-Yuan	Kuei-Shan	Taiwan
104	Yungkang City	Tainan	Taiwan
105	Tainan		Taiwan
106	Taipei		Taiwan
107	Bristol	Avon	United Kingdom
108	Hull	East Yorkshire	United Kingdom
109	Acton	London	United Kingdom
110	Northwood	Middlesex	United Kingdom
111	Belfast	Northern Ireland	United Kingdom
112	Manchester		United Kingdom
113	Valencia	Edo. Aragua	Venezuela
114	Estado Aragua	Maracay	Venezuela
115	Caracas		Venezuela