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Phase III Study of Irinotecan and Cetuximab vs Irinotecan as Second-Line Treatment in Patients with Metastatic, EGFR-Positive Colorectal Cancer

This study is currently recruiting patients.

Sponsored by: ImClone Systems
Bristol-Myers Squibb
Information provided by: ImClone Systems

Purpose

The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, EGFR-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.

Condition Treatment or Intervention Phase
Colorectal Cancer
 Drug: cetuximab
Phase III

MedlinePlus related topics:  Colorectal Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 

Expected Total Enrollment:  1300

Study start: April 2003

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Exclusion Criteria


Location and Contact Information


Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States; Recruiting
Dayle Craig, RN  205-975-8080 
Andres Forero-Torres, MD,  Principal Investigator

      Comprehensive Cancer Institute, Huntsville,  Alabama,  35801,  United States; Recruiting
Kathy Cutter, RN  256-705-4248 
John Waples, MD,  Principal Investigator

      Comprehensive Cancer Institute, Huntsville,  Alabama,  35801,  United States; Recruiting
Kathy Cutter, RN  256-705-4248 
John Waples, MD,  Principal Investigator

Alaska
      Providence Alaska Medical Center, Anchorage,  Alaska,  99508,  United States; Recruiting
Kathleen Shue, RN  907-261-3109 
Latha Subramanian, MD,  Principal Investigator

      Anchorage Oncology Centre, Anchorage,  Alaska,  99508,  United States; Recruiting
Kathleen Shue, RN  907-261-3109 
Latha Subramanian, MD,  Principal Investigator

      Katmai Oncology Group, Anchorage,  Alaska,  99508,  United States; Recruiting
Kathleen Shue, RN  907-261-3109 
Latha Subramanian, MD,  Principal Investigator

Arizona
      ACRC/Arizona Clinical Research Center, Tucson,  Arizona,  85712,  United States; Recruiting
Megan Colman  520-290-2510 
Manuel Modiano, MD,  Principal Investigator

Arkansas
      Little Rock Hematology Oncology, Little Rock,  Arkansas,  72205,  United States; Recruiting
P Gray  501-907-6177  Ext. 421 
Brad Baltz, MD,  Principal Investigator

      Arkansas Cancer Center, Pine Bluff,  Arkansas,  71603,  United States; Recruiting
Kelli Bradshaw  870-535-2800 
Omar Atiq, MD,  Principal Investigator

      Little Rock Hematology Oncology Associates, Little Rock,  Arkansas,  72205,  United States; Recruiting
Priscilla Gray  501-907-6177 
Diane Wilder, MD,  Principal Investigator

California
      New Hope Cancer & Research, Inc., Pomona,  California,  91767,  United States; Recruiting
R Cruz  909-620-5502 
Vandana Agarwal, MD,  Principal Investigator

      California Cancer Care, Greenbrae,  California,  95904,  United States; Recruiting
J Chang  415-925-5001 
Peter D Eisenberg, MD,  Principal Investigator

      Compassionate Cancer Care Medical, Fountain Valley,  California,  92708,  United States; Recruiting
A Reeves  714-210-2300 
Haresh S Jhangiani, MD,  Principal Investigator

      Stockton Hematology Oncology Medical Group, Stockton,  California,  95204,  United States; Recruiting
Y Bossert  209-466-2626 
Aminder Mehdi, MD,  Principal Investigator

      South Valley Medical Plaza, Gilroy,  California,  95020,  United States; Recruiting
M Beck  408-847-6191 
Ronald Yanagihara, MD,  Principal Investigator

      Pacific Shores Medical Group, Long Beach,  California,  90813,  United States; Recruiting
Dale Gloudon  562-590-0345  Ext. 238 
Simon Tchekmedyian, MD,  Principal Investigator

      Kenmar Research Institute, Los Angeles,  California,  90057,  United States; Recruiting
Amy Spitzer  213-989-1888 
Peter Kennedy, MD,  Principal Investigator

      Cancer and Blood Institute of the Desert, Rancho Mirage,  California,  92270,  United States; Recruiting
Susan Sagle, RN  760-568-4461 
Robert Lemon, MD,  Principal Investigator

      Comprehensive Blood and Cancer Center, Bakersfield,  California,  93309,  United States; Recruiting
Pamela Checci, RN  661-332-2206 
Ravi Patel, MD,  Principal Investigator

      Medical Oncology Care Associates, Orange,  California,  92868,  United States; Recruiting
Lillian Dvorak, RN, BSN  714-541-6622 
Birbal Bhaskar, MD,  Principal Investigator

      Kaiser Permanente Medical Center, Vallejo,  California,  94589,  United States; Recruiting
Andrea Rodoni  707-651-3391 
Louis Fehrenbacher, MD,  Principal Investigator

      Oncology Care Medical Associates, Montebello,  California,  90640,  United States; Recruiting
Jody Agena  213-989-1888 
Ira Felman, MD,  Principal Investigator

      Oncology Care Medical Associates, San Grabiel,  California,  91776,  United States; Recruiting
Jody Agena  213-989-1888 
Ira Felman, MD,  Principal Investigator

      Oncology Care Medical Associates, Whittier,  California,  90602,  United States; Recruiting
Jody Agena  213-989-1888 
Ira Felman, MD,  Principal Investigator

      Kenmar Research Institute, LLC, Los Angeles,  California,  90057,  United States; Recruiting
Christine Marion  818-840-0921 
Raul Mena, MD,  Principal Investigator

      Tower Hematology/Oncology, Los Angeles,  California,  90048,  United States; Recruiting
Marilyn Chavez  310-854-9267 
Barry Rosenbloom, MD,  Principal Investigator

Colorado
      Rocky Mountain Cancer Center-Midtown, Denver,  Colorado,  80218,  United States; Recruiting
Joni Newman  303-388-4876 
Allen Cohn, MD,  Principal Investigator

Connecticut
      Bennett Cancer Center at Stamford Hospital, Stamford,  Connecticut,  06902,  United States; Recruiting
Susan Murdock  203-323-8944 
Salvatore Del Prete, MD,  Principal Investigator

      Bendheim Cancer Center, Greenwich,  Connecticut,  06830,  United States; Recruiting
Irene Piazza, RN, MSN, OCN  203-863-3942 
Monica Leon  203-863-3705 
Arthur Rosenberg, MD,  Principal Investigator

      Northwestern Connecticut Oncology/Hematology, Torrington,  Connecticut,  06790,  United States; Recruiting
Meg Toro  860-482-5384 
Debra Brandt, MD,  Principal Investigator

      Yale University School of Medicine, New Haven,  Connecticut,  06520,  United States; Recruiting
Lisa Furino  203-785-6781 
Barbara Burtness, MD,  Principal Investigator

      Eastern CT Hematology Oncology Associates, Norwich,  Connecticut,  06360,  United States; Recruiting
Ann Slam  860-886-8362 
Dinesh Kapur, MD,  Principal Investigator

Florida
      Florida Oncology Associates, Jacksonville,  Florida,  32207,  United States; Recruiting
G Quilon  904-739-7779 
Yousif Abubakr, MD,  Principal Investigator

      Pasco Hernando Oncology, North Port Richey,  Florida,  34652,  United States; Recruiting
E Crosariol  727-842-2795 
Kapisthalam S Kumar, MD,  Principal Investigator

      Hematology & Medical Oncology of Southern Palm Beach County, Inc., Boynton Beach,  Florida,  33435,  United States; Recruiting
Donna Stefinsky, RN, CCRC  561-374-5020 
Roger Brito, MD,  Principal Investigator

      Hematology-Oncology Associates, Port Sainte Lucie,  Florida,  34952,  United States; Recruiting
Christine Baker, RN  772-335-5666  Ext. 244 
Nicholas Iannotti, MD,  Principal Investigator

      University of Florida/Jacksonville, Jacksonville,  Florida,  32209,  United States; Recruiting
Joyce Willis, RN  904-244-4378 
Troy Guthrie, Jr., MD,  Principal Investigator

      Lake Heart and Cancer Medical Center, Leesburg,  Florida,  34748,  United States; Recruiting
Kathy Magurean, RN  352-753-5433 
Lourdes Mathew, MD,  Principal Investigator

      Palm Beach Institute of Hematology & Oncology, Boynton Beach,  Florida,  33435,  United States; Recruiting
Renee Martin, RN, CRC  561-374-5020 
Eyal Meiri, MD,  Principal Investigator

      M.D. Anderson Cancer Center Orlando, Orlando,  Florida,  32806,  United States; Recruiting
Trudy Graves, MS, RN  321-841-5646 
Omar Kayaleh, MD,  Principal Investigator

      Space Coastal Medical Associates, Titusville,  Florida,  32796,  United States; Recruiting
Linda Turner  321-268-4200 
Richard Levine, MD,  Principal Investigator

      Ocala Oncology Center, Ocala,  Florida,  34474,  United States; Recruiting
John Bunting  352-732-4938 
Thomas Cartwright, MD,  Principal Investigator

      Watson Clinic, LLP Center for Cancer Care & Research, Lakeland,  Florida,  33805,  United States; Recruiting
Debra Lane  863-603-4724 
Luis Franco, MD,  Principal Investigator

      Jackson Memorial Hospital & Clinics, Miami,  Florida,  33136,  United States; Recruiting
Hilda Santrock  305-243-8807 
Pasquale Benedetto, MD,  Principal Investigator

      Mayo Clinic Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Bridget Strong  904-953-6824 
George Kim, MD,  Principal Investigator

      Lakeheart and Medical Center, Leesburg,  Florida,  34748,  United States; Recruiting
K. Magurean  352-753-5433 
Lourdes Matthew, MD,  Principal Investigator

      Medical Oncology Hematology, Tampa,  Florida,  33613,  United States; Recruiting
Margie Blazek  813-615-7200 
Ron Schiff, MD,  Principal Investigator

      Lakeland Regional Cancer Center, Lakeland,  Florida,  33805,  United States; Recruiting
Patricia Gowland, RN, BSN  863-904-1875 
James Jakub, MD,  Principal Investigator

Georgia
      Pasco Hernando Oncology Associates, Brooksville,  Georgia,  34613,  United States; Recruiting
C Rhinesmith  352-596-1401 
Raju Rao, MD,  Principal Investigator

      Peachtree Hematology and Oncology, Atlanta,  Georgia,  30309,  United States; Recruiting
L Hofer  678-298-3241 
Charles A Henderson, MD,  Principal Investigator

      Central Georgia Hematology and Oncology, Macon,  Georgia,  31201,  United States; Recruiting
J Kerr  478-743-7068 
Frederick Schnell, MD,  Principal Investigator

      Georgia Cancer Specialist, Tucker,  Georgia,  30342,  United States; Recruiting
Chris Moore  770-496-9427 
Mansoor Saleh, MD,  Principal Investigator

      Coastal Hematology & Oncology, Savannah,  Georgia,  31406,  United States; Recruiting
Joni Hein, RN, BSN  912-351-9500 
Brian Kim, MD,  Principal Investigator

Idaho
      St. Luke's Mountain State Tumor Institute, Boise,  Idaho,  83712,  United States; Recruiting
Jane Harris, MS, RN,  208-381-3132 
Theodore Walters, MD,  Principal Investigator

Illinois
      Joliet Oncology Hematology Associates, Joliet,  Illinois,  60435,  United States; Recruiting
Dana Lewis  815-730-3098 
Sarode Pundaleeka, MD,  Principal Investigator

      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068,  United States; Recruiting
Michelle Martin  847-723-8502 
Brian Samuels, MD,  Principal Investigator

      Edward Cancer Center, Naperville,  Illinois,  60540,  United States; Recruiting
Jeannie Sixta, RN  630-527-3787 
Alexander Hantel, MD,  Principal Investigator

Indiana
      Oncology & Hematology Associates, Inc., Indianapolis,  Indiana,  46227,  United States; Recruiting
Jayme Harvey  317-859-5500 
David Loesch, MD,  Principal Investigator

Kansas
      Kansas University Medical Center, Kansas City,  Kansas,  66160,  United States; Recruiting
Rebecca Clark-Snow, RN, BSN, OCN  913-588-4714 
Stephen Williamson, MD,  Principal Investigator

      Kansas City Oncology & Hematology Group, Lenexa,  Kansas,  66214,  United States; Recruiting
Vickie Thomas  913-541-4641 
Robert Belt, MD,  Principal Investigator

      Kansas City Cancer Centers, Overland Park,  Kansas,  66214,  United States; Recruiting
Vickie Thomas  913-541-4641 
Marcus Neubauer, MD,  Principal Investigator

Louisiana
      Hematology/Oncology Clinic, Baton Rouge,  Louisiana,  70808,  United States; Recruiting
Evita Key  225-381-6451 
Gerald Miletello, MD,  Principal Investigator

      Oncology and Hematology, Metairie,  Louisiana,  70006,  United States; Recruiting
Jeannette Vicknair, RN  504-885-0577 
Jane Gurtler, MD,  Principal Investigator

Maryland
      Greater Baltimore Medical Center, Baltimore,  Maryland,  21204,  United States; Recruiting
Justin Pyrke-Fairchild  443-849-3122 
Marshall Levine, MD,  Principal Investigator

Michigan
      Cook Research Institute at Spectrum Health, Grand Rapids,  Michigan,  49503,  United States; Recruiting
Debbie Ritz-Holland  616-391-9363 
Lawrence Pawl, MD,  Principal Investigator

      St. Joseph Mercy Hospital Cancer Care Center, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Linda Beekman  734-712-5947 
Philip Stella, MD,  Principal Investigator

      West Michigan Cancer Center, Kalamazoo,  Michigan,  490007,  United States; Recruiting
Joan Westerndorp  269-373-7458 
Raymond Lord, III, MD,  Principal Investigator

      Providence Cancer Center, Southfield,  Michigan,  48075,  United States; Recruiting
Carol Muzyk  248-849-8234 
Anibal Drelichman, MD,  Principal Investigator

Minnesota
      Hubert H. Humphrey Cancer Center, Robbinsdale,  Minnesota,  55422,  United States; Recruiting
Nancy Sundeen, RN  763-520-5847 
Ross Siemers, MD,  Principal Investigator

Mississippi
      North Mississippi Hematology & Oncology Associates, Ltd., Tupelo,  Mississippi,  38801,  United States; Recruiting
Marthe Thomas, RN, BSN  662-844-9166 
Christopher Croot, MD,  Principal Investigator

      Jackson Oncology Associates, Jackson,  Mississippi,  39202,  United States; Recruiting
Anne Berthold, NP  601-974-5534 
Grace Shumaker, MD,  Principal Investigator

Missouri
      Bond Clinic, Rolla,  Missouri,  65401,  United States; Recruiting
R Drewel  573-364-8823 
Joseph C Bond, MD,  Principal Investigator

      Capital Comprehensive Cancer Care Clinic, Jefferson City,  Missouri,  65109,  United States; Recruiting
J Chambers  573-893-6404 
Ali Khojasteh, MD,  Principal Investigator

      Washington University Medical Center, St. Louis,  Missouri,  63110,  United States; Recruiting
Dawn Arrington  314-362-4636 
Joel Picus, MD,  Principal Investigator

New York
      Hemoncare, Brooklyn,  New York,  11235,  United States; Recruiting
L Helgesen  718-616-0801 
Fakhuiddin Ahmed, MD,  Principal Investigator

      New York Oncology Hematology, Latham,  New York,  12148,  United States; Recruiting
A Cicchinelli  518-786-7721  Ext. 260 
Siddique Tai, MD,  Principal Investigator

      New York Oncology Hematology, Latham,  New York,  12110,  United States; Recruiting
K Dissito  518-786-7721 
Charles Weissman, MD,  Principal Investigator

      New York Oncology Hematology, Albany,  New York,  12208,  United States; Recruiting
K Fredericks  518-489-0444 
Lawrence E Garbo, MD,  Principal Investigator

      Our Lady of Mercy Medical Center, Bronx,  New York,  10466,  United States; Recruiting
Linda Sacris  718-920-9057 
Sandeep Malik, MD,  Principal Investigator

      Stony Brook University Hospital, Stony Brook,  New York,  11794,  United States; Recruiting
June Giardelli, RN  631-444-7931 
Stefan Madejewicz, MD,  Principal Investigator

      School of Medicine, New York University, New York,  New York,  10016,  United States; Recruiting
Mindy Everett  212-652-1965 
Howard Hochster, MD,  Principal Investigator

      New York Medical College/Westchester, Valhalla,  New York,  10595,  United States; Recruiting
Amir Iqbal  914-594-4400 
Hoo Chun, MD,  Principal Investigator

      North Shore Hematology/Oncology Associates, P.C., East Setauket,  New York,  11733,  United States; Recruiting
Sharon Goldberg  631-751-3000 
Brian Samuels, MD,  Principal Investigator

      Winthrop University Hospital, Mineola,  New York,  11501,  United States; Recruiting
Hoda Wali, MD  516-663-9569 
Harry Staszewski, MD,  Principal Investigator

      North Shore Hematology/Oncology, East Setauket,  New York,  11733,  United States; Recruiting
Sharon Goldberg  631-751-3000 
Edward Samuel, MD,  Principal Investigator

North Carolina
      Raleigh Hematology Oncology Associates, Raleigh,  North Carolina,  27609,  United States; Recruiting
R Butler  919-431-9201 
Margaret Deutsch, MD,  Principal Investigator

      Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157,  United States; Recruiting
Karen Craver, MT, MHA  336-713-4394 
Coty Ho, MD,  Principal Investigator

North Dakota
      St. Alexius Medical Center, Mid Dakota, Bismark,  North Dakota,  58501,  United States; Recruiting
D Sanders  701-530-6900 
Bipinkumar Amin, MD,  Principal Investigator

Ohio
      Hematology Oncology Consultants, Columbus,  Ohio,  43235,  United States; Recruiting
J Wilson  614-846-0044 
Leslie R Laufman, MD,  Principal Investigator

      Hematology Oncology Consultants Inc, Newark,  Ohio,  43055,  United States; Recruiting
B Glaub  614-846-0044 
Charalampos Spirdonidis, MD,  Principal Investigator

      Dayton Clinical Oncology Program, Dayton,  Ohio,  45429,  United States; Recruiting
Katherine Peyton, RN  937-279-5847 
Howard Gross, MD,  Principal Investigator

      Alliance Cancer Center, Dayton,  Ohio,  45459,  United States; Recruiting
Krista Bensman, RN  937-298-3399  Ext. 57556 
Stuart Merl, MD,  Principal Investigator

      Barrett Cancer Center University of Cincinnati, Cincinnati,  Ohio,  45267,  United States; Recruiting
Marsha Zartman, RN  513-584-1021 
Abdul Jazieh, MD,  Principal Investigator

Pennsylvania
      Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States; Recruiting
Cynthia Campbell, RN  717-531-8796 
Alan Lipton, MD,  Principal Investigator

      Pennsylvania Oncology/Hematology Associates, Philadelphia,  Pennsylvania,  19106,  United States; Recruiting
Millie Cappa  215-829-6712 
Bernard Mason, MD,  Principal Investigator

      Central Pennsylvania Hematology & Medical Oncology Associates, P.C., Lemoyne,  Pennsylvania,  17043,  United States; Recruiting
Nancy Cribari  717-737-3704 
John Conroy, MD,  Principal Investigator

South Carolina
      Charleston Cancer Center, Charleston,  South Carolina,  29406,  United States; Recruiting
M Martin  843-572-9211 
William Schmidt, MD,  Principal Investigator

Tennessee
      Thompson Cancer Survival Center, Knoxville,  Tennessee,  37916,  United States; Recruiting
Paula Hux, RN  865-541-4967 
Samuel McCachren, Jr., MD,  Principal Investigator

      The West Clinic, P.C., Memphis,  Tennessee,  38120,  United States; Recruiting
Sherry Hodges  901-683-0055  Ext. 1049 
Lee Schwartzberg, MD,  Principal Investigator

Texas
      Center for Oncology Research and Treatment, Dallas,  Texas,  75230,  United States; Recruiting
C Teel  972-566-8153 
Barry Mirtsching, MD,  Principal Investigator

      Lone Star Oncology Consultants, Austin,  Texas,  78759,  United States; Recruiting
T Bell  512-343-2103 
John Costanzi, MD,  Principal Investigator

      Scott & White Memorial Hospital, Temple,  Texas,  76508,  United States; Recruiting
Melissa Ainslie  254-724-1372 
Lucas Wong, MD,  Principal Investigator

      North Texas Regional Cancer Center, Plano,  Texas,  75075,  United States; Recruiting
Cindi Bedell  972-867-3577 
Charles Connor, MD,  Principal Investigator

      Southwest Regional Cancer Center, Austin,  Texas,  78705,  United States; Recruiting
Heidi Herndon, RN, BSN, OCN  512-421-4163 
Robert Kerr, MD,  Principal Investigator

      Texas Oncology, PA-Medical City, Dallas,  Texas,  75230,  United States; Recruiting
Rhonda Waldrop  972-566-4291 
Michael Savin, MD,  Principal Investigator

      UT M.D. Anderson Cancer Center, Houston,  Texas,  77030,  United States; Recruiting
Karla Bogaard, RN  713-792-2232 
Cathy Eng, MD,  Principal Investigator

Utah
      Northern Utah Hematology and Oncology, Ogden,  Utah,  84403,  United States; Recruiting
M Hansen  801-387-7150 
Vincent Hansen, MD,  Principal Investigator

Virginia
      Danville Hematology and Oncology, Danville,  Virginia,  24541,  United States; Recruiting
C Daniel  434-793-0044 
Timothy W Brotherton, MD PhD,  Principal Investigator

      Arlington-Fairfax Hematology Oncology, Arlington,  Virginia,  22205,  United States; Recruiting
M Garcia  703-528-7303 
Robert Meister, MD,  Principal Investigator

      Virginia Oncology Associates, Newport News,  Virginia,  23606,  United States; Recruiting
Ora Mae Jackon  757-873-9400 
Joseph Schulz, MD,  Principal Investigator

      Virginia Oncology Associates, Norfolk,  Virginia,  23502,  United States; Recruiting
Anita Hailey  757-466-8683 
Paul Conkling, MD,  Principal Investigator

Washington
      Cancer Care Northwest-North, Spokane,  Washington,  99218,  United States; Recruiting
Rosalee Miller  509-464-5100 
Stephen Anthony, MD,  Principal Investigator

      Southwest Washington Medical Center, Vancouver,  Washington,  98664,  United States; Recruiting
Beth Getman, RN  360-514-2016 
Rakesh Gaur, MD,  Principal Investigator

      Medical Oncology Associates, Spokane,  Washington,  99208,  United States; Recruiting
Vicki Townsend, RN  509-252-6313 
Arvind Chaudhry, MD,  Principal Investigator

      St. Mary Medical Center St. Mary Regional Cancer Center, Walla Walla,  Washington,  99362,  United States; Recruiting
Cathy McCauley  509-522-5993 
Robert Quackenbush, MD,  Principal Investigator

Wisconsin
      UW Cancer Center Wausau Hospital, Wausau,  Wisconsin,  54401,  United States; Recruiting
Beth Knetter, RN  715-847-2353 
Harish Ahuja, MD,  Principal Investigator

      St. Vincent Hospital, Green Bay,  Wisconsin,  54301,  United States; Recruiting
Jolene Cheslock  920-431-3194 
James McGovern, MD,  Principal Investigator

      Froedtert Memorial Lutheran Hospital/Clinic, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
Rachel Bostetter  414-805-4628 
Paul Ritch, MD,  Principal Investigator

      University of Wisconsin Hospital and Clinics, Madison,  Wisconsin,  53792,  United States; Recruiting
Torie Dzelak  608-265-1181 
Daniel Mulkerin, MD,  Principal Investigator

More Information

Study ID Numbers:  CA225006
Record last reviewed:  March 2004
Record first received:  June 20, 2003
ClinicalTrials.gov Identifier:  NCT00063141
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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