Ongoing Clinical Trials

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1 1999 S. Karger AG, Basel Fax karger@karger.ch Accessible online at: Clinical Trials Section Editor: S. Galandiuk, MD, Louisville This section provides information for researchers on clinical s being in progress in their field throughout the world. The list of s described herein is by no means inclusive, and the publisher is not responsible for any data given. Please use the special questionnaire at the end of this section to submit information on a new. Oncology ESPAC-1 Adjuvant therapy in operable pancreatic cancer Prof. J.P. Neoptolemos Department of Surgery, University of Liverpool, UK European multicenter (80 centers) ; Patients randomized into one of four groups (chemotherapy; radiotherapy; radiotherapy and chemotherapy; observation only) 2x2 factorial design Follow-up for 5 years Control: Surgery only Endpoint: 2-year survival resected pancreatic cancer n=561 (start 1994; end 1999) Cancer Research Campaign Mrs. J. Almond, Coordinator Liverpool, UK Tel: Fax: j.almond@liverpool.ac.uk ESPAC-3 Adjuvant chemotherapies in operable pancreatic cancer Prof. J.P. Neoptolemos Department of Surgery, University of Liverpool, UK European multicenter (80 centers) ; patients randomized into one of three groups (surgery alone; gemcitabine; 5-fluorouracil and folinic acid) Endpoint: 2-year survival resected pancreatic cancer n=990 In development (start when ESPAC-1 closes) Cancer Research Campaign Mrs. J. Almond, Coordinator Liverpool, UK Tel: Fax: j.almond@liverpool.ac.uk

2 446 Clinical Trials Clinical Trials (continued) Neoadjuvant chemoradiation in pancreatic cancer Single center, prospective, nonrandomized irresectable or uncertain resectable pancreatic cancer n=50 Additional information: Pilot project, further study planned (start 1996) Dr. S. Kastl Tel: Fax: Open label phase II study of ras oncogene peptide immunotherapy with adjuvant GM-CSF in patients with nonresectable pancreatic adenocarcinoma Prof. Dr. M.W. Büchler Inselspital Bern, Switzerland Phase II, multicenter, prospective Endpoint: 6-month survival, determination of immunological response n=50-70 (start February 1999; Merck Dr. K. Z graggen Bern, Switzerland Tel: Fax: kaspar.zgraggen@insel.ch Prospective randomized of standard versus radical pancreatoduodenectomy for patients with periampullary adenocarcinoma The Johns Hopkins University School of Medicine, Baltimore, Md., USA Single-center, prospective, singleblind Control: Standard Whipple versus radical Whipple Endpoint: Morbidity, mortality, survival resectable periampullary adenocarcinoma n >300 Published: Ann Surg 229: ,1999 Baltimore, Md., USA Tel: Fax: cyeo@jhmi.edu Quality of life in patients with pancreatic cancer Single center, prospective, nonrandomized Endpoint: Death of patient Patient population: All patients with primary pancreatic cancer treated at the University of Erlangen-Nürnberg n=200 (start September 1999; end December 2001) ELAN Fond University of Erlangen Dr. S. Kastl / Dr. S. Merkel Tel: Fax: Susanne.Merkel@chir.med.unierlangen.de 446

3 Clinical Trials 447 Clinical Trials (continued) Prospective, randomized, double-blind of prophylactic octreotide for pancreatoduodenectomy The Johns Hopkins University School of Medicine, Baltimore, Md., USA Independent, single-center, prospective, double-blind Regimen: Octreotide, 250 µg SQ, t.d.s. for 7 days Endpoint: Pancreatic fistula, morbidity, mortality Patient population: Undergoing Whipple procedure n>300 (start 1997; end 2000) Baltimore, Md., USA Tel: Fax: cyeo@jhmi.edu CAPP 2 Randomized controlled of colorectal polyp and cancer prevention using aspirin and resistant starch in carriers of hereditary nonpolyposis colon cancer (HNPCC) Prof. John Burn University of Newcastle, UK Phase II, multicenter (50 centers), prospective, double-blind Factorial design /active Regimen: Aspirin 600 mg, resistant starch 3 g for 2-4 years Endpoint: Colorectal neoplasm Patient population: Gene carriers of hereditary HNPCC n=1500 (start January 1999; end December 2003) Imperial Cancer Research Fund, Biomed 2, Bayer Prof. John Burn Newcastle upon Tyne, UK Tel: Fax: john.burn@nd.ac.uk Adjuvant versus neoadjuvant radiochemotherapy for locally advanced rectal cancer groups Regimen: 50.4 Gy (+ 5.4 Gy boost postoperatively); 5-FU 5,000 mg/m² twice preoperatively and 5- FU 2,500 mg/m² four times postoperatively for 6 months Control: Uncontrolled Endpoint: Survival, disease-free survival locally advanced rectum cancer (CS II + III) without distant metastases Additional information: Clinical staging for preoperative randomization ; patients randomized into Phase III, multicenter, prospective (start February 1995) Dr. Ch. Schick Tel: schick@stones.com 447

4 448 Clinical Trials Clinical Trials (continued) InTACT Interdisciplinary of adjuvant colon cancer treatment Phase III, multicenter, prospective, investigator-blind Regimen: 24-hour infusion with 5-FU (2,000 mg/m²) ; folinic acid (500 mg/m²) once weekly for 6 months (adjuvant treatment arm) Control: Adjuvant therapy versus surgery (quality controlled) alone Endpoint: Survival, disease-free survival stage III (UICC) colon cancer complete resection (R0) n=240 Additional information: Interim analysis after randomization of 120 patients (start March 1996; end 2002) Dr. Bertram Reingruber Tel: Fax: bertram.reingruber@stud.unierlangen.de Inflammatory Bowel Disease A 6- or 12-month randomized, doublemasked, placebocontrolled, three-arm study to evaluate the safety and efficacy of ISIS 2302 in steroiddependent Crohn s disease Phase II, multicenter, double-blind Endpoint: Off steroids n=10 (start May 1999; end May 2000) ISIS Anna Williford, RN Tel: Fax: Motility Two-period, doubleblind, placebo-controlled to evaluate the effects of re-treatment efficacy and safety in subjects with chronic constipation Phase III, multicenter (35 centers), double-blind Regimen: 12 weeks q.d. constipation n=18 (start June 1999; Janssen Anna Williford, RN Tel: Fax:

5 Clinical Trials 449 Clinical Trials (continued) Surgical Infection / Sepsis Multicenter, singleblind, placebocontrolled, randomized, dose-escalation study of recombinant tissue factor pathway inhibitor in severe sepsis Phase II, multicenter, prospective, double-blind Regimen: 4-day treatment period Endpoint: Mortality, cytokine levels sepsis n=280 (start January 1999; Chiron William Cheadle, MD Tel: Treatment of complicated bacterial skin and soft-tissue infections due to Gram-positive bacteria Phase III, multicenter (35 centers), investigator-blind Regimen: 7- to 21-day treatment period Control: Uncontrolled n=8 (start June 1999; Cubist Anna Williford, RN Tel: Fax: Multicenter, randomized, open-label study to compare the safety and efficacy of levofloxacin with that of imipenem/ cilastatin in the treatment of nosocomial pneumonia Phase IV, multicenter, prospective, open-label Regimen: Levofloxacin 750 mg b.d., Primaxin 1 g t.d.s. for 7-14 days Control: Active-controlled Endpoint: Pneumonia cure rates/relapse rates nosocomial pneumonia n=150 RW Johnson PRI Hiram C. Polk, Jr., MD Tel: Randomized, doubleblind, placebo-controlled to assess the safety of bactericidal/ permeability-increasing protein in patients with hemorrhage due to trauma Phase III, multicenter, prospective, double-blind Regimen: 8 mg/kg for 2 days Endpoint: Morbidity Patient population: Trauma patients who have received 72 U blood n=1800 (start March 1998; end January 2000) Xoma Mark Wilson, MD Tel:

6 450 Clinical Trials Clinical Trials (continued) Phase IIb study to evaluate the safety and efficacy of recombinant platelet-activating factor acetylhydrolase for the prevention of acute respiratory distress syndrome in patients with severe sepsis or severe traumatic injuries Phase II, multicenter, prospective, double-blind Regimen: 1 or 5 mg for 5 days Endpoint: Morbidity sepsis or trauma n=240 (start October 1998) ICOS David A. Spain, MD Tel: Predictive values of HLA-DR and of stimulated TNF-α production in SICU patients Priv. Doz. Dr. W. Haupt Single center, prospective Control: Immuno-competence versus immuno-paralysis Endpoint: Mortality severe sepsis / SIRS n=60 (start March 1999; end March 2000) Priv. Doz. Dr. W. Haupt Tel: Fax: werner.haupt@chir.med.unierlangen.de Regulatory mechanisms of the production of cytokines and chemokines by the human peritoneum Priv. Doz. Dr. W. Haupt Single center, prospective Control: Noninfected versus peritonitis Endpoint: Cytokine and chemokine production Patient population: Patients undergoing major abdominal surgery n=200 Additional information: Immune regulation; basic immunology; therapeutic options (Start 1997; end 2002) BMBF Priv. Doz. Dr. W. Haupt Tel: Fax: werner.haupt@chir.med.unierlangen.de Early enteral versus parenteral nutrition in severe sepsis Gerardo Mangiante, MD University of Verona, Italy Multicenter, prospective, investigator-blind Control: Early enteral nutrition versus parenteral nutrition Endpoint: Infection of pancreatic necrosis, mortality, length of hospital stay n=200 (start Juli 1999; end July 2001) Gerardo Mangiante, MD Claudio Bassi, MD Verona, Italy Tel: / Fax: gerardo@borgorome.univv.it / bifo@borgorome.univv.it 450

7 Clinical Trials 451 Clinical Trials (continued) Miscellaneous Tensiometry for risk assessment of incisional hernia formation after open abdominal surgery Prof. Dr. P. Klein Independent (investigatorinitiated), single center, prospective, investigator-blind Endpoint: Absence versus presence of incisional hernia 1 year postoperatively Patient population: Patients undergoing open abdominal surgery n=100 (start September 1999; end September 2000) Prof. Dr. Peter Klein Tel: peter.klein@chir.med.unierlangen.de Mesh plug versus Lichtenstein, prospective and randomized study Dr. A. Wildisen Universität Basel, Switzerland Phase III, multicenter, prospective, single-blind study Endpoint: Hernia recurrence n=900 (start March 1999) Dr. A. Wildisen Basel, Switzerland Tel: