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Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas Clinical research trials and Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas. Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas clinical trial. Subjects typically recieve the finest healthcare available for their Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.

Home > "G" Clinical Trials Conditions > Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas

Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas



Gemcitabine With or Without Cetuximab as First-Line Therapy in Treating Patients With Locally Advanced Unresectable or Metastatic Adenocarcinoma of the Pancreas

For Condition: stage 4A pancreatic cancer,stage 4B pancreatic cancer,adenocarcinoma of the pancreas,stage 3 pancreatic cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as cetuximab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether gemcitabine is more effective with or without cetuximab in treating pancreatic cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of gemcitabine with or without cetuximab as first-line therapy in treating patients who have locally advancedunresectable or metastaticadenocarcinoma of the pancreas.
Details: OBJECTIVES: - Compare the overall survival of patients with locally advanced unresectable or metastatic adenocarcinoma of the pancreas treated with gemcitabine and cetuximab vs gemcitabine alone. - Compare the time to treatment failure in patients treated with these regimens. - Estimate the percentage of patients with epidermal growth factor receptor (EGFR) tumor expression in patients treated with these regimens. - Compare the overall survival of patients in the EGFR-positive subset treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the total response rate (confirmed and unconfirmed complete and partial response) in patients with measurable disease treated with these regimens. - Compare the patient report of pain and quality of life of patients treated with these regimens. OUTLINE: This is an open-label, randomized, multicenter study. Patients are stratified according to disease status (locally advanced unresectable vs metastatic), Zubrod performance status (0 or 1 vs 2), and prior pancreatectomy (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22 and gemcitabine IV over 30 minutes on days 1, 8, 15, and 22 for course 1 and days 1, 8, and 15 for all subsequent courses. - Arm II: Patients receive gemcitabine as in arm I. In both arms, courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before each course, and at the end of study therapy. Patients are followed every 6 months for 2 years and then annually for 1 year. PROJECTED ACCRUAL: A total of 704 patients (352 per treatment arm) will be accrued for this study within 5 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed pancreatic adenocarcinoma meeting 1 of the following criteria: - Locally advanced unresectable disease - Distant metastatic disease - Measurable or nonmeasurable disease by x-ray, scan, or physical examination - Tumor tissue must be submitted for evaluation of epidermal growth factor receptor expression before study entry - No endocrine tumors or lymphoma of the pancreas - No known brain metastases PATIENT CHARACTERISTICS: Age - Not specified Performance status - Zubrod 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 2.0 times upper limit of normal (ULN) - SGOT or SGPT no greater than 2.5 times ULN Renal - Creatinine no greater than 2.0 mg/dL Cardiovascular - No significant history of cardiac disease - No uncontrolled hypertension - No unstable angina - No congestive heart failure Other - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - 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 adequately treated stage I or II cancer that is currently in remission PRIOR CONCURRENT THERAPY: Biologic therapy - No prior immunotherapy for advanced pancreatic cancer - No prior cetuximab or other therapy that targets the epidermal growth factor pathway - No prior chimerized or murine monoclonal antibody therapy - No other concurrent anticancer immunotherapy Chemotherapy - No prior chemotherapy or chemoradiotherapy for advanced pancreatic cancer - At least 6 months since prior adjuvant chemotherapy - No other concurrent anticancer chemotherapy Endocrine therapy - No prior hormonal therapy for advanced pancreatic cancer - No concurrent anticancer hormonal therapy Radiotherapy - See Chemotherapy - At least 28 days since prior radiotherapy and recovered - Prior palliative radiotherapy to metastatic sites allowed - No concurrent anticancer radiotherapy, including whole brain radiotherapy for progressive disease (i.e., CNS metastasis) Surgery - At least 14 days since prior pancreatic cancer surgery and recovered Other - No other concurrent anticancer therapy
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PhilipPhilip,  ,  Barbara Ann Karmanos Cancer Institute

Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Geoffrey  Weiss 210-617-5120

Veterans Affairs Medical Center - Temple *Recruiting*
Temple,  Texas,  76504
United States
Recruiting Phalguni  Mukhopadhyay 254-778-4811 ext. 4809

CCOP - Greenville *Recruiting*
Greenville,  South Carolina,  29615
United States
Recruiting Jeffrey  Giguere 864-241-6251

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62526
United States
Recruiting James  Wade 217-876-6617

Cancer Institute at Oregon Health and Science University *Recruiting*
Portland,  Oregon,  97201-3098
United States
Recruiting Craig  Nichols 503-494-6346

Veterans Affairs Medical Center - Little Rock (McClellan) *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Bart  Barlogie 501-526-2873

Tripler Army Medical Center *Recruiting*
Honolulu,  Hawaii,  96859-5000
United States
Recruiting Brian  Issell 808-433-4089

CCOP - Northwest *Recruiting*
Tacoma,  Washington,  98405-0986
United States
Recruiting Lauren  Colman 253-403-1461

Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita,  Kansas,  67218
United States
Recruiting Shaker  Dakhil 316-685-2221

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting William  Robinson 806-355-9703

Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit,  Michigan,  48201-1379
United States
Recruiting Lawrence  Flaherty 313-745-9155

Veterans Affairs Medical Center - Houston *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Gauri  Varadhachary 713-791-1414 ext. 5340

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

David Grant Medical Center *Recruiting*
Travis Air Force Base,  California,  94535
United States
Recruiting David  Gandara 707-423-7300

James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Richard  Fisher 585-275-0842

Veterans Affairs Medical Center - Shreveport *Recruiting*
Shreveport,  Louisiana,  71130
United States
Recruiting Glenn  Mills 318-221-8411

CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield,  Missouri,  65807
United States
Recruiting John  Goodwin 417-269-4520

Veterans Affairs Medical Center - Dayton *Recruiting*
Dayton,  Ohio,  45428-1002
United States
Recruiting Howard  Gross 937-268-6511

University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor,  Michigan,  48109-0912
United States
Recruiting Laurence  Baker 734-936-3983

Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson,  Arizona,  85724
United States
Recruiting Thomas  Miller 520-626-2667

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange,  California,  92868
United States
Recruiting Randall  Holcombe 714-456-5153

Mayo Clinic *Recruiting*
Jacksonville,  Florida,  32224
United States
Recruiting Edith  Perez 904-953-0118

Veterans Affairs Medical Center - Albany *Recruiting*
Albany,  New York,  12208
United States
Recruiting James  Holland 518-462-3311 ext. 2328

Veterans Affairs Medical Center - Memphis *Recruiting*
Memphis,  Tennessee,  38104
United States
Recruiting Mohammad  Jahanzeb 901-523-8990

Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Thomas  Lad 312-996-2046

CCOP - St. Louis-Cape Girardeau *Recruiting*
St. Louis,  Missouri,  63141
United States
Recruiting Patrick  Henry 314-569-6573

Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Robert  Chapman 313-916-1850

CCOP - Dayton *Recruiting*
Dayton,  Ohio,  45429
United States
Recruiting Howard  Gross 937-395-8678

Cancer Research Center of Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

Veterans Affairs Medical Center - Oklahoma City *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-270-0501

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) *Recruiting*
Phoenix,  Arizona,  85012
United States
Recruiting Thomas  Kummet 602-277-5551

Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque,  New Mexico,  87108-5138
United States
Recruiting Douglas  Clark 505-243-4039

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

University of Arkansas for Medical Sciences *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Laura  Hutchins 501-686-8511

Veterans Affairs Medical Center - Tucson *Recruiting*
Tucson,  Arizona,  85723
United States
Recruiting Thomas  Miller 520-792-1450 ext. 16631

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

Veterans Affairs Medical Center - Portland *Recruiting*
Portland,  Oregon,  97207
United States
Recruiting Craig  Nichols 503-220-8262

Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport,  Louisiana,  71130-3932
United States
Recruiting Glenn  Mills 318-675-7639

Veterans Affairs Medical Center - New Orleans *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Alan  Miller 504-589-5250

Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City,  Kansas,  66160-7390
United States
Recruiting James  Thrasher 913-588-6152

Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield,  Michigan,  48075
United States
Recruiting Anibal  Drelichman 313-552-0620

Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor,  Michigan,  48105
United States
Recruiting Laurence  Baker 734-769-7100

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4095
United States
Recruiting Scott  Lippman 713-745-3672

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-1781
United States
Recruiting John  Barstis 310-825-5268

Veterans Affairs Medical Center - Kansas City *Recruiting*
Kansas City,  Missouri,  64128
United States
Recruiting Sarah  Taylor 816-861-4700 ext. 491

Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Daniel  Petrylak 212-305-1731

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus *Recruiting*
Seattle,  Washington,  98104
United States
Recruiting Saul  Rivkin 206-386-2929

University of Mississippi Medical Center *Recruiting*
Jackson,  Mississippi,  39216-4505
United States
Recruiting James  Thigpen 601-984-5590

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0501
United States
Recruiting Abdul-Rahman  Jazieh 513-584-3830

University of Texas Medical Branch *Recruiting*
Galveston,  Texas,  77555-0565
United States
Recruiting Robert  Whitehead 409-772-1164

Veterans Affairs Medical Center - Detroit *Recruiting*
Detroit,  Michigan,  48201-1932
United States
Recruiting Lawrence  Flaherty 313-576-1000

CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa,  California,  95403
United States
Recruiting Ian  Anderson 707-521-3859

Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood,  Illinois,  60153-5500
United States
Recruiting Patrick  Stiff 708-327-3148

Madigan Army Medical Center *Recruiting*
Tacoma,  Washington,  98431-5000
United States
Recruiting Patrick  Williams 253-968-2505

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875

City of Hope Comprehensive Cancer Center *Recruiting*
Duarte,  California,  91010-0269
United States
Recruiting Kim  Margolin 626-359-8111

USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles,  California,  90033
United States
Recruiting Heinz-Josef  Lenz 323-865-3955

CCOP - Upstate Carolina *Recruiting*
Spartanburg,  South Carolina,  29303
United States
Recruiting James  Bearden 864-560-7050

Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland,  Ohio,  44195-9001
United States
Recruiting George  Budd 216-444-6480

Tulane University School of Medicine *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Alan  Miller 504-587-7566

University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora,  Colorado,  80010
United States
Recruiting Anthony  Elias 720-848-1622

Veterans Affairs Medical Center - Lexington *Recruiting*
Lexington,  Kentucky,  40502-2236
United States
Recruiting Michael  Doukas 859-281-4956

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Kathleen  Yost 616-391-1230

MBCCOP - Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

St. Louis University Hospital Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Paul  Petruska 314-577-8854

Cancer Research Center at Boston Medical Center *Recruiting*
Boston,  Massachusetts,  02118
United States
Recruiting Douglas  Faller 617-638-8000

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio,  Texas,  78229-3900
United States
Recruiting Geoffrey  Weiss 210-617-5120

Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston,  South Carolina,  29401-5799
United States
Recruiting Carolyn  Reed 843-789-7865

Veterans Affairs Medical Center - Salt Lake City *Recruiting*
Salt Lake City,  Utah,  84148
United States
Recruiting Wolfram  Samlowski 801-582-1565

CCOP - Columbus *Recruiting*
Columbus,  Ohio,  43206
United States
Recruiting J.  Kuebler 614-488-2118

Harrington Cancer Center *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting James  Clarkson 806-359-4673

CCOP - Beaumont *Recruiting*
Royal Oak,  Michigan,  48073-6769
United States
Recruiting David  Decker 248-551-7695

CCOP - Bay Area Tumor Institute *Recruiting*
Oakland,  California,  94609-3305
United States
Recruiting Joseph  Szumowski 510-465-8570

MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C.,  District of Columbia,  20060
United States
Recruiting Lucile  Adams-Campbell 202-806-7697

MBCCOP - Gulf Coast *Recruiting*
Mobile,  Alabama,  36607
United States
Recruiting Paul  Schwarzenberger 251-544-1013

Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati,  Ohio,  45220-2288
United States
Recruiting Abdul-Rahman  Jazieh 513-861-3100 ext. 6537

Brooke Army Medical Center *Recruiting*
Fort Sam Houston,  Texas,  78234-6200
United States
Recruiting Mitchell  Garrison 210-916-0504

CCOP - Virginia Mason Research Center *Recruiting*
Seattle,  Washington,  98101
United States
Recruiting Andrew  Jacobs 206-341-0446

CCOP - Atlanta Regional *Recruiting*
Atlanta,  Georgia,  30342-1701
United States
Recruiting Thomas  Seay 404-851-2340

MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque,  New Mexico,  87131
United States
Recruiting Cheryl  Willman 505-272-5837

Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi,  Mississippi,  39531-2410
United States
Recruiting Robert  Veith 504-568-5151

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-271-4022

Huntsman Cancer Institute *Recruiting*
Salt Lake City,  Utah,  84112-5550
United States
Recruiting Wolfram  Samlowski 801-585-0255

Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle,  Washington,  98108
United States
Recruiting William  Schubach 206-764-2265

Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez,  California,  94553
United States
Recruiting David  Gandara 925-372-2064

MBCCOP - Massey Cancer Center *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting John  Roberts 804-828-0450

University of Tennessee Cancer Institute *Recruiting*
Memphis,  Tennessee,  38103
United States
Recruiting Mohammad  Jahanzeb 901-722-0532

CCOP - Wichita *Recruiting*
Wichita,  Kansas,  67214-3882
United States
Recruiting Shaker  Dakhil 316-268-5784

MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Jill  Gilbert 504-568-5136

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) *Recruiting*
Hines,  Illinois,  60141
United States
Recruiting Nirmala  Bhoopalam 708-202-2782

Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston,  South Carolina,  29425
United States
Recruiting Carolyn  Reed 843-792-3362

CCOP - Montana Cancer Consortium *Recruiting*
Billings,  Montana,  59101
United States
Recruiting Patrick  Cobb 406-259-2245

Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington,  Kentucky,  40536-0084
United States
Recruiting Michael  Doukas 859-257-4500

Veterans Affairs Medical Center - Jackson *Recruiting*
Jackson,  Mississippi,  39216
United States
Recruiting James  Thigpen 601-362-4471


Additional Information:
Study ID Numbers:
  CDR0000347414;  SWOG-S0205
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075686

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2. UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer

3. BBR 3464 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer That Cannot be Treated With Surgery

4. Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

5. Chemotherapy, Interferon alfa, and Radiation Therapy in Treating Patients Who Have Undergone Surgery For Pancreatic Cancer

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