Study on Fruquintinib Plus FOLFIRI as Second-Line Treatment for Metastatic Colorectal Cancer
Sponsor: SCRI Development Innovations, LLC
ClinicalTrials ID:NCT07011576
This clinical trial is testing a combination of the drug Fruquintinib with a chemotherapy regimen called FOLFIRI to see if it is effective and safe for patients with metastatic colorectal cancer who have already received initial treatment.
Patient Parameters
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Program Overview
This study is exploring a new treatment option for patients with metastatic colorectal cancer (mCRC) who have already been treated with a first-line therapy. The treatment combines Fruquintinib, a drug that blocks the growth of new blood vessels that feed tumors, with a chemotherapy regimen known as FOLFIRI. The main goals are to see how well this combination works in shrinking tumors and to assess its safety for patients.
Description
Fruquintinib is a medication approved by the FDA that targets specific proteins involved in the formation of new blood vessels, which are crucial for tumor growth. By inhibiting these proteins, Fruquintinib helps prevent tumors from getting the nutrients and oxygen they need to grow. This study is a Phase II trial, meaning it focuses on evaluating the effectiveness and safety of the treatment. Participants in the study will receive Fruquintinib along with FOLFIRI, a combination of chemotherapy drugs, as a second-line treatment after their initial therapy with FOLFOX and Bevacizumab. Up to 60 participants will be involved in this study, receiving the treatment according to standard guidelines for metastatic colorectal cancer.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of metastatic colorectal cancer (mCRC) with adenocarcinoma of the colon or rectum and at least one measurable tumor.
- Have genetic changes in the cancer, except for specific types known as MSI-H and BRAF V600.
- Have previously received FOLFOX and Bevacizumab as first-line treatment for mCRC.
- Be at least 18 years old.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
Exclusion Criteria
- Currently receiving other cancer treatments within 21 days before starting the study treatment.
- Have had major surgery within 4 weeks before starting the study treatment.
- Have received more than one prior treatment for mCRC before joining the study.
- Have uncontrolled or symptomatic brain metastases.
- Have uncontrolled or symptomatic gastrointestinal disease.
- Have uncontrolled high blood pressure.
- Women who are pregnant, nursing, or planning to become pregnant during the study and for at least 6 months after the last treatment.
- Men planning to father a child during the study and for at least 6 months after the last treatment.
- Have significant abnormalities in heart function tests.
- Have other active invasive cancers within the last 5 years.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Rocky Mountain Cancer Center - Primary | 80218 | Denver | Colorado |
| Maryland Oncology Hematology | 21044 | Columbia | Maryland |
| Minnesota Oncology Hematology - Primary | 55369 | Maple Grove | Minnesota |
| Oncology Associates of Oregon - Primary | 97401 | Eugene | Oregon |
| Northwest Cancer Specialists - Compass | 97213 | Portland | Oregon |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| Texas Oncology - Central/South Texas | 78705 | Austin | Texas |
| Texas Oncology - Gulf Coast | 77702 | Beaumont | Texas |
| Texas Oncology - Northeast Texas | 75702 | Tyler | Texas |
| Virginia Oncology Associates | 23502 | Norfolk | Virginia |
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