A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
- Conditions
- Colorectal Cancer
- Interventions
- Drug: 5-Fluorouracil, Leukovorin, bevacizumab
- Registration Number
- NCT00388700
- Lead Sponsor
- Galectin Therapeutics Inc.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GM-CT-01 GM-CT-01 - GM-CT-01 5-Fluorouracil, Leukovorin, bevacizumab -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (4)
Rambam Medical Center
🇮🇱Haifa, Israel
Kaplan MC
🇮🇱Rechovot, Israel
Sheba MC
🇮🇱Tel Hashomer, Israel
Sourasky Medical Center
🇮🇱Tel-Aviv, Israel