A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00388700|
Recruitment Status : Withdrawn (Financing and re-organization)
First Posted : October 17, 2006
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: GM-CT-01 Drug: 5-Fluorouracil, Leukovorin, bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
On Day 1 and 2 of each cycle, GM-CT-01 280 mg/m2 administered IV over 30 minutes with 5-FU (400 mg/m2), followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) with 5-FU (600 mg/m2 .)
Other Name: DAVANAT
Drug: 5-Fluorouracil, Leukovorin, bevacizumab
On Day 1 and 2 of each cycle, LV (200 mg/m2) will be administered IV over 2 hours, followed by 5-FU 400 mg/m2 in solution with GM-CT-01 280 mg/m2 administered over 30 minutes, followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) and 5-FU (600 mg/m2 ). on Day 3 Avastin® (5 mg/kg)will be given IV over 30 to 90 minutes per the package insert.
Other Name: 5-FU, LV, Avastin®
- 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 ]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 ]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 ]To explore time to tumor progression, duration of response and and survival at 6 and 12 months after the first dose of study drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388700
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Tel Hashomer, Israel, 52621|
|Sourasky Medical Center|
|Tel-Aviv, Israel, 64239|