A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
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.
Drug: 5-Fluorouracil, Leukovorin, bevacizumab
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label, Phase 2 Study of GM-CT-01 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|
- Primary Outcomes: Assess the efficacy and safety of GM-CT-01 administered with 5-FU, LV, and Avastin® in the first-line treatment of unresectable, locally advanced, and/or metastatic CRC. [ Time Frame: When 17 evaluable patients will complete the study ] [ Designated as safety issue: Yes ]To assess the clinical benefit of a regimen of GM-CT-01/5-FU, LV plus Avastin® when administered intravenously as a first-line treatment to patients with Stage III or IV ,advanced or metastatic CRC. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete response [CR]) plus partial response [PR]). Tumor response will be assessed following Response Evaluation by RECIST guidelines.
- To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen. [ Time Frame: Throughout the study and when 17 evaluable patients will when complete the study ] [ Designated as safety issue: Yes ]Assess safety of regimen and also patient reported outcomes using a Quality of Life (QoL) instrument.
- Explore progression-free survival (PFS) and survival [ Time Frame: When at least 17 evaluable patients complete the study ] [ Designated as safety issue: No ]To explore time to tumor progression, duration of response and and survival at 6 and 12 months after the first dose of study drug.
|Study Start Date:||October 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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.
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Tel Hashomer, Israel, 52621|
|Sourasky Medical Center|
|Tel-Aviv, Israel, 64239|