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Sponsored by: |
Pro-Pharmaceuticals |
Information provided by: | Pro-Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00388700 |
The purpose of this clinical trial is to determine whether the combination of 5-fluorouracil (5-FU) plus a DAVANAT (carbohydrate polymer) along with Avastin and Leucovorin (LV) is beneficial in treating colorectal cancer in patients unable to tolerate intensive chemotherapy.
Condition | Intervention | Phase |
Colorectal Cancer |
Drug: DAVANAT |
Phase II |
MedlinePlus related topics: | Cancer Colorectal Cancer |
ChemIDplus related topics: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Bevacizumab Fluorouracil |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label, Phase 2 Study of DAVANAT When Added to a Regimen of Leucovorin, 5-FU, and Avastin as First Line Treatment for Locally Advanced, Unresectable or Metastatic Colorectal Cancer in Subjects Unable to Tolerate Intensive Chemotherapy |
Estimated Enrollment: | 50 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | June 2009 |
This is a Phase II, multi-center study of DAVANAT which has been shown to increase the anti-tumor activity of 5-FU in mice. 5-FU is a chemotherapy drug commonly used to treat tumors. A Phase I study of 40 patients showed that DAVANAT in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hana Chen-Walden, MD | 33 6 07 86 46 21 | hana.chen-walden@euclinreg.com |
Israel | |||||
Sheba MC | Recruiting | ||||
Tel Hashomer, Israel, 52621 | |||||
Contact: Saya Ben-Arieh 03-530-4437 Sayeh.ben-Arieh@Sheba.health.gov.il | |||||
Contact 054-460-0404 | |||||
Principal Investigator: Dan Aderka, M.D. | |||||
Kaplan MC | Recruiting | ||||
Rechovot, Israel | |||||
Contact: Zahava Tabachnik 08-944-1007 zehava_t@clalit.org.il | |||||
Contact 08-944-1088 | |||||
Principal Investigator: Efraim Idilevich, M.D. | |||||
Rambam Medical Center | Recruiting | ||||
Haifa, Israel, 31096 | |||||
Contact: Anat Ronai 04-854-1814 a_ronay@rambam.health.gov.il | |||||
Contact 04-854-3152 | |||||
Principal Investigator: Alex Beny, MD | |||||
Sourasky Medical Center | Recruiting | ||||
Tel-Aviv, Israel, 64239 | |||||
Contact: Karen Nalbandyan, M.D 03-697-4815 sarahb@tasmc.health.gov.il | |||||
Contact: Michal Caspi 03-697-3082 afiger@tasmc.health.gov.il | |||||
Principal Investigator: Einat Shacham-Shmueli, MD |
Pro-Pharmaceuticals |
Responsible Party: | ( Eliezer Zomer ) |
Study ID Numbers: | DAVFU006 |
First Received: | October 13, 2006 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00388700 |
Health Authority: | United States: Food and Drug Administration |
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