Extended-duration Oxaliplatin Infusion for Gastrointestinal Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well giving oxaliplatin over 6 hours works in treating nerve damage in patients with gastrointestinal cancers. Oxaliplatin can cause side effects such as nerve damage that may delay or reduce the dose of oxaliplatin. Giving oxaliplatin over a longer period of time (6 hours) may prevent or delay the development of nerve damage, which may keep patients on standard doses of chemotherapy longer, without having to delay treatment.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently receiving anticancer therapies or have received any within 14 days of starting the trial.
What data supports the effectiveness of the drug Oxaliplatin (Eloxatin) for gastrointestinal cancer?
Oxaliplatin has shown effectiveness in treating advanced colorectal cancer, a type of gastrointestinal cancer, especially when combined with other drugs like 5-fluorouracil (5-FU). Studies have shown that this combination can increase response rates and delay tumor progression compared to using 5-FU alone.12345
Is extended-duration Oxaliplatin infusion safe for humans?
Oxaliplatin is generally well tolerated in humans, with common but manageable side effects like gastrointestinal issues and increased risk of certain blood-related side effects. The most significant concern is neurological side effects, which can be acute and reversible or longer-lasting with higher doses, but these usually improve after stopping treatment.16789
How is the drug oxaliplatin used in the treatment of gastrointestinal cancer different from other treatments?
The extended-duration infusion of oxaliplatin for gastrointestinal cancer is unique because it involves a longer infusion time, which may enhance its effectiveness compared to standard shorter infusions. Oxaliplatin is a platinum-based drug that works by blocking DNA replication in cancer cells, and it is often used in combination with other drugs like 5-fluorouracil to improve treatment outcomes.1251011
Research Team
Olumide B. Gbolahan, MBBS, MSc
Principal Investigator
Emory University
Eligibility Criteria
This trial is for adults with gastrointestinal cancers planning to undergo at least 4 cycles of FOLFOX6 chemotherapy. They must have a confirmed diagnosis, measurable disease, and be in good enough health to participate (ECOG status 0-2). Participants need normal blood counts and organ function, and women who can become pregnant must use effective birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oxaliplatin and leucovorin infusions, with courses repeating every 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Oxaliplatin
Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
- Colorectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
University of Pittsburgh
Collaborator
Hematology/Oncology Pharmacy Association
Collaborator