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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
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 .)
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.
Rambam Medical Center
Haifa, Israel
Kaplan MC
Rehovot, Israel
Sourasky Medical Center
Tel Aviv, Israel
Sheba MC
Tel Litwinsky, Israel
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.
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.
Time frame: When 17 evaluable patients will complete the study
To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen.
Assess safety of regimen and also patient reported outcomes using a Quality of Life (QoL) instrument.
Time frame: Throughout the study and when 17 evaluable patients will when complete the study
Explore progression-free survival (PFS) and survival
To explore time to tumor progression, duration of response and and survival at 6 and 12 months after the first dose of study drug.
Time frame: When at least 17 evaluable patients complete the study
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