Colorectal Cancer
Conditions
Keywords
Colorectal cancer, DAVANAT, colon cancer, 5-FU
Brief summary
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.
Detailed description
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.
Interventions
DRUGGM-CT-01
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 .)
DRUG5-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.
Sponsors
Galectin Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older. * Histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage III and IV), not amenable to curative surgery or radiotherapy. * Intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the Investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan, * Presence of at least 1 measurable lesion, * Have a life expectancy of at least 4 months. * Women of childbearing potential, have a negative serum pregnancy test at screening and Day 1 treatment and agree to practice abstinence or use an effective method of contraception.
Exclusion criteria
* Central nervous system metastasis. * Bony metastasis as the sole metastasis. * Received any prior first-line chemotherapy for colorectal cancer. * Previously exposed to DAVANAT® or Avastin®. * Known or clinically suspected infection with HIV. * Participated within 30 days or will participate concurrently in another investigational drug or vaccine study. * History of drug or alcohol dependence in the past 3 years. * Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the Investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen. | 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 | 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. |
Countries
Israel
Outcome results
None listed