A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
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|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Recruitment Status : Withdrawn (Financing and re-organization)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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|