A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GM-CT-01
|
Drug: GM-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 .)
Other Names:
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 Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years or older.
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Histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage III and IV), not amenable to curative surgery or radiotherapy.
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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,
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Presence of at least 1 measurable lesion,
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Have a life expectancy of at least 4 months.
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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:
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Central nervous system metastasis.
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Bony metastasis as the sole metastasis.
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Received any prior first-line chemotherapy for colorectal cancer.
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Previously exposed to DAVANAT® or Avastin®.
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Known or clinically suspected infection with HIV.
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Participated within 30 days or will participate concurrently in another investigational drug or vaccine study.
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History of drug or alcohol dependence in the past 3 years.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rambam Medical Center | Haifa | Israel | 31096 | |
| 2 | Kaplan MC | Rechovot | Israel | ||
| 3 | Sheba MC | Tel Hashomer | Israel | 52621 | |
| 4 | Sourasky Medical Center | Tel-Aviv | Israel | 64239 |
Sponsors and Collaborators
- Galectin Therapeutics Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DAVFU006