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Selected Clinical Trials in Colorectal Cancer
Clinical
Trials
Selected Clinical Trials in Metastatic Colorectal Cancer Metastatic Trials Sponsor: Eli Lilly and Company ClinicalTrials.gov Identifier: NCT00437268 Study Start: March 2007 Title: A Randomized Phase 2 Study of Irinotecan plus Cetuximab with or Without Enzastaurin in Patients with Recurrent Colorectal Cancer Purpose: To evaluate enzastaurin (LY317615.HCl; a protein kinase (PKCß) that is a selective inhibitor of AKT pathway) in combination with irinotecan/ cetuximab versus irinotecan/cetuximab in patients with recurrent CRC Contact: Study Director, Eli Lilly and Company; 877-CTLILLY (877-285-4559)
or 317-615-4559 Drugs: Enzastaurin, irinotecan, and cetuximab Outcome: Primary endpoint for this study is progression-free survival (PFS) Key Eligibility: Histologic diagnosis of CRC; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; documented disease progression within 3 months after receiving FOLFOX (oxaliplatin/leucovorin [LV]/5-fluourouracil [5-FU])/bevacizumab as first-line therapy for locally advanced or metastatic disease, or within 6 months after receiving FOLFOX with or without bevacizumab in the adjuvant setting
Sponsor: Austrian Society of Surgical Oncology ClinicalTrials.gov Identifier: NCT00444041 Study Start: January 2007 Title: Pre- and Postoperative Chemotherapy Including Bevacizumab in Potentially Curable Metastatic Colorectal Cancer (mCRC). A Multicenter, Single Arm Phase I/II Academic Trial Purpose: To evaluate safety and efficacy of neoadjuvant treatment of bevacizumab in potentially unresectable patients with metastatic CRC (mCRC) Contact: Thomas Gruenberger, MD, Principal Investigator; Austrian Society of Surgical Oncology; 43-1-40400 Ext. 5621; [email protected]
Drugs: Bevacizumab Outcome: The primary objective of this study is the resectability (R0) rate after the treatment of neoadjuvant bevacizumab in potentially resectable mCRC; feasibility with regard to gastrointestinal bleeding and wound healing complications after surgery of liver metastases; overall response rate (RR); recurrence-free survival; overall survival (OS) Key Eligibility: Histologically confirmed mCRC including potentially resectable liver metastases; aged q 18 years; previous adjuvant or neoadjuvant chemotherapy/radiation therapy; ECOG PS 0/1; life expectancy > 3 months; adequate hematologic function
Sponsor: GlaxoSmithKline ClinicalTrials.gov Identifier: NCT00540943 Study Start: October 2007 Title: A Phase I, Open Label, Study of the Safety, Tolerability and Pharmacokinetics of Pazopanib in Combination with Irinotecan and Cetuximab for the Relapsed or Refractory Metastatic Colorectal Cancer Purpose: To recruit patients for the dose escalation phase in order to determine the maximum tolerated dose (MTD). Additionally, 18 patients will be
recruited once the MTD is determined for disease assessment Contact: GSK Clinical Trials, MD, Study Chair; 877-379-3718 Drugs: Pazopanib, irinotecan, and cetuximab Outcome: Safety and tolerability; dose-limiting toxicities (DLTs) to determine maximum tolerated regimen Key Eligibility: Histologic diagnosis of CRC; documented disease progression; ECOG PS of 0/1; ability to swallow and retain oral medication; adequate bone marrow (BM) and renal functions
Sponsor: Ludwig-Maximilians - University of Munich, Merck, Hoffmann-La Roche ClinicalTrials.gov Identifier: NCT00433927 Study Start: January 2007 Title: Multicenter Randomized Trial Evaluating FOLFIRI plus Cetuximab Versus Bevacizumab in First-Line Treatment of Metastatic Colorectal Cancer Purpose: This multicenter, randomized, phase II, FIRE-3 trial is investigating 5-FU, LV, and irinotecan (FOLFIRI [irinotecan/LV/5-FU])/cetuximab versus bevacizumab in first-line treatment of mCRC Contact: Volker Heinemann, MD, Principal Investigator; 49-89-70950;
[email protected] Drugs: 5-FU, LV, irinotecan, cetuximab, and bevacizumab Outcome: Objective RR; median PFS; median OS; secondary resection rate with curative intent; safety and toxicity (according to National Cancer Institute-Common Terminology Criteria for Adverse Events) Key Eligibility: Histologic confirmed adenocarcinoma of the colon or rectum; stage IV disease; ECOG PS of 0-2; aged 18-75 years; estimated life expectancy > 3 months; measurable index lesion; evaluation of tumor manifestations a 2 weeks before treatment start; adequate hematologic functions
Sponsor: Swiss Group for Clinical Cancer Research ClinicalTrials.gov Identifier: NCT00544700 Study Start: October 2007 Title: Bevacizumab Maintenance versus No Maintenance After Stop of First-Line Chemotherapy in Patients with Metastatic Colorectal Cancer. A Randomized Multicenter Phase III Non-Inferiority Trial Purpose: This randomized phase III trial is evaluating bevacizumab in patients who have undergone first-line therapy for mCRC Contact: Dieter Koeberle, MD, Study Chair; 41-71-494-1111;
[email protected] Drugs: Bevacizumab Outcome: Time to progression (TTP); OS; PFS; adverse events; long-term bevacizumab treatment costs Key Eligibility: Histologic confirmed mCRC; received previous first-line chemotherapy with oral or intravenous (I.V.) fluoropyrimidine alone or in combination with irinotecan or oxaliplatin; stable disease (SD), partial response, or complete response after completion of first-line treatment; no clinical symptoms or history of central nervous system metastases allowed
Electronic forwarding or copying is a violation of US and International Copyright Laws. Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by CIG Media Group, LP, ISSN #1533-0028, provided the appropriate fee is paid directly to Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923 USA 978-750-8400.
Clinical Colorectal Cancer November 2007
• 731
Trials
Selected Clinical Trials in Metastatic Colorectal Cancer Metastatic Trials Sponsor: Eli Lilly and Company ClinicalTrials.gov Identifier: NCT00437268 Study Start: March 2007 Title: A Randomized Phase 2 Study of Irinotecan plus Cetuximab with or Without Enzastaurin in Patients with Recurrent Colorectal Cancer Purpose: To evaluate enzastaurin (LY317615.HCl; a protein kinase (PKCß) that is a selective inhibitor of AKT pathway) in combination with irinotecan/ cetuximab versus irinotecan/cetuximab in patients with recurrent CRC Contact: Study Director, Eli Lilly and Company; 877-CTLILLY (877-285-4559)
or 317-615-4559 Drugs: Enzastaurin, irinotecan, and cetuximab Outcome: Primary endpoint for this study is progression-free survival (PFS) Key Eligibility: Histologic diagnosis of CRC; Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2; documented disease progression within 3 months after receiving FOLFOX (oxaliplatin/leucovorin [LV]/5-fluourouracil [5-FU])/bevacizumab as first-line therapy for locally advanced or metastatic disease, or within 6 months after receiving FOLFOX with or without bevacizumab in the adjuvant setting
Sponsor: Austrian Society of Surgical Oncology ClinicalTrials.gov Identifier: NCT00444041 Study Start: January 2007 Title: Pre- and Postoperative Chemotherapy Including Bevacizumab in Potentially Curable Metastatic Colorectal Cancer (mCRC). A Multicenter, Single Arm Phase I/II Academic Trial Purpose: To evaluate safety and efficacy of neoadjuvant treatment of bevacizumab in potentially unresectable patients with metastatic CRC (mCRC) Contact: Thomas Gruenberger, MD, Principal Investigator; Austrian Society of Surgical Oncology; 43-1-40400 Ext. 5621; [email protected]
Drugs: Bevacizumab Outcome: The primary objective of this study is the resectability (R0) rate after the treatment of neoadjuvant bevacizumab in potentially resectable mCRC; feasibility with regard to gastrointestinal bleeding and wound healing complications after surgery of liver metastases; overall response rate (RR); recurrence-free survival; overall survival (OS) Key Eligibility: Histologically confirmed mCRC including potentially resectable liver metastases; aged q 18 years; previous adjuvant or neoadjuvant chemotherapy/radiation therapy; ECOG PS 0/1; life expectancy > 3 months; adequate hematologic function
Sponsor: GlaxoSmithKline ClinicalTrials.gov Identifier: NCT00540943 Study Start: October 2007 Title: A Phase I, Open Label, Study of the Safety, Tolerability and Pharmacokinetics of Pazopanib in Combination with Irinotecan and Cetuximab for the Relapsed or Refractory Metastatic Colorectal Cancer Purpose: To recruit patients for the dose escalation phase in order to determine the maximum tolerated dose (MTD). Additionally, 18 patients will be
recruited once the MTD is determined for disease assessment Contact: GSK Clinical Trials, MD, Study Chair; 877-379-3718 Drugs: Pazopanib, irinotecan, and cetuximab Outcome: Safety and tolerability; dose-limiting toxicities (DLTs) to determine maximum tolerated regimen Key Eligibility: Histologic diagnosis of CRC; documented disease progression; ECOG PS of 0/1; ability to swallow and retain oral medication; adequate bone marrow (BM) and renal functions
Sponsor: Ludwig-Maximilians - University of Munich, Merck, Hoffmann-La Roche ClinicalTrials.gov Identifier: NCT00433927 Study Start: January 2007 Title: Multicenter Randomized Trial Evaluating FOLFIRI plus Cetuximab Versus Bevacizumab in First-Line Treatment of Metastatic Colorectal Cancer Purpose: This multicenter, randomized, phase II, FIRE-3 trial is investigating 5-FU, LV, and irinotecan (FOLFIRI [irinotecan/LV/5-FU])/cetuximab versus bevacizumab in first-line treatment of mCRC Contact: Volker Heinemann, MD, Principal Investigator; 49-89-70950;
[email protected] Drugs: 5-FU, LV, irinotecan, cetuximab, and bevacizumab Outcome: Objective RR; median PFS; median OS; secondary resection rate with curative intent; safety and toxicity (according to National Cancer Institute-Common Terminology Criteria for Adverse Events) Key Eligibility: Histologic confirmed adenocarcinoma of the colon or rectum; stage IV disease; ECOG PS of 0-2; aged 18-75 years; estimated life expectancy > 3 months; measurable index lesion; evaluation of tumor manifestations a 2 weeks before treatment start; adequate hematologic functions
Sponsor: Swiss Group for Clinical Cancer Research ClinicalTrials.gov Identifier: NCT00544700 Study Start: October 2007 Title: Bevacizumab Maintenance versus No Maintenance After Stop of First-Line Chemotherapy in Patients with Metastatic Colorectal Cancer. A Randomized Multicenter Phase III Non-Inferiority Trial Purpose: This randomized phase III trial is evaluating bevacizumab in patients who have undergone first-line therapy for mCRC Contact: Dieter Koeberle, MD, Study Chair; 41-71-494-1111;
[email protected] Drugs: Bevacizumab Outcome: Time to progression (TTP); OS; PFS; adverse events; long-term bevacizumab treatment costs Key Eligibility: Histologic confirmed mCRC; received previous first-line chemotherapy with oral or intravenous (I.V.) fluoropyrimidine alone or in combination with irinotecan or oxaliplatin; stable disease (SD), partial response, or complete response after completion of first-line treatment; no clinical symptoms or history of central nervous system metastases allowed
Electronic forwarding or copying is a violation of US and International Copyright Laws. Authorization to photocopy items for internal or personal use, or the internal or personal use of specific clients, is granted by CIG Media Group, LP, ISSN #1533-0028, provided the appropriate fee is paid directly to Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923 USA 978-750-8400.
Clinical Colorectal Cancer November 2007
• 731