60 Participants Needed

Extended-duration Oxaliplatin Infusion for Gastrointestinal Cancer

Recruiting at 2 trial locations
AD
RD
OB
Overseen ByOlumide B. Gbolahan, MBBS, MSc
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Emory University
Must be taking: FOLFOX6
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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

OB

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

Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
My white blood cell count is healthy without medication.
My cancer is confirmed and measurable or can be evaluated.
See 8 more

Exclusion Criteria

I do not have any severe infections or serious liver conditions.
I do not have severe heart problems like recent heart attacks or uncontrolled heart failure.
I haven't had cancer treatment in the last 2 weeks.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oxaliplatin and leucovorin infusions, with courses repeating every 14 days

Up to 60 days
Every 14 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months
Visits at 1, 3, 6, 12, and 18 months

Treatment Details

Interventions

  • Oxaliplatin
Trial OverviewThe study is testing if giving the drug Oxaliplatin over a longer period (6 hours) reduces nerve damage compared to standard infusion times. This could help patients maintain their regular chemotherapy doses without delays due to side effects.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: 6-hour infusion groupExperimental Treatment3 Interventions
Patients receive oxaliplatin IV over 6 hours on day 1. Patients also receive leucovorin and fluorouracil as in the 2-hour infusion group. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Group II: 2-hour infusion groupActive Control3 Interventions
Patients receive oxaliplatin IV and leucovorin IV over 2 hours on day 1. Patients also receive a lower dose of fluorouracil IV over 2-4 minutes followed by a higher dose IV continuous over 4-6 hours on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:

🇪🇺
Approved in European Union as Eloxatin for:
  • Colorectal cancer
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Approved in United States as Eloxatin for:
  • Colorectal cancer
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Approved in Canada as Eloxatin for:
  • Colorectal cancer
🇯🇵
Approved in Japan as Eloxatin for:
  • Colorectal cancer
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Approved in Switzerland as Eloxatin for:
  • Colorectal cancer
🇨🇳
Approved in China as Ai Heng for:
  • Colorectal cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

University of Pittsburgh

Collaborator

Trials
1,820
Recruited
16,360,000+

Hematology/Oncology Pharmacy Association

Collaborator

Trials
1
Recruited
60+

Findings from Research

In a study involving 206 patients with advanced colorectal carcinoma who had previously failed 5-FU-based therapy, the addition of oxaliplatin to 5-FU +/- folinic acid resulted in a 25.5% objective response rate, demonstrating its efficacy as a salvage therapy.
The median overall survival for patients receiving oxaliplatin combined with 5-FU +/- FA was 9.6 months, indicating that this treatment can provide significant benefits for patients resistant to prior fluoropyrimidine therapies.
Oxaliplatin added to 5-fluorouracil-based therapy (5-FU +/- FA) in the treatment of 5-FU-pretreated patients with advanced colorectal carcinoma (ACRC): results from the European compassionate-use program.Brienza, S., Bensmaïne, MA., Soulié, P., et al.[2020]
Oxaliplatin, when combined with fluorouracil (5-FU), has shown significantly higher response rates (60% or more) in patients with untreated advanced colorectal cancer compared to lower rates when used alone (12% to 24%).
While adding oxaliplatin to 5-FU and leucovorin improves response rates and delays tumor progression, it does not appear to extend overall survival, indicating a need for further research to understand this outcome.
Efficacy of oxaliplatin in the treatment of colorectal cancer.Rothenberg, ML.[2022]
Oxaliplatin combined with 5-FU/FA significantly improves response rates and progression-free survival in patients with advanced metastatic colorectal cancer, showing a response rate of 45% compared to 31% for irinotecan/5-FU/FA in a study of 795 patients.
While oxaliplatin can cause dose-limiting neurotoxicity, its overall tolerability is manageable, making it a valuable first- or second-line treatment option for colorectal cancer, especially in patients who have failed irinotecan-based therapies.
Oxaliplatin: a review of its use in combination therapy for advanced metastatic colorectal cancer.Simpson, D., Dunn, C., Curran, M., et al.[2022]

References

Oxaliplatin added to 5-fluorouracil-based therapy (5-FU +/- FA) in the treatment of 5-FU-pretreated patients with advanced colorectal carcinoma (ACRC): results from the European compassionate-use program. [2020]
Efficacy of oxaliplatin in the treatment of colorectal cancer. [2022]
Oxaliplatin: a review of its use in combination therapy for advanced metastatic colorectal cancer. [2022]
[Oxaliplatin -- A 10-Year Trajectory]. [2018]
Characterization of nano oxaliplatin prepared by novel Fat Employing Supercritical Nano System, the FESNS®. [2018]
[Oxaliplatin tolerance in the treatment of metastatic colorectal cancers]. [2018]
The incidence rate of allergic reactions induced by oxaliplatin is higher in patients with rectal cancer compared with colon cancer. [2023]
Safety Profile of Oxaliplatin in 3,687 Patients With Cancer in China: A Post-Marketing Surveillance Study. [2022]
Safety of oxaliplatin in the treatment of colorectal cancer. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Novel combinations with oxaliplatin. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Oxaliplatin: a new therapeutic option in colorectal cancer. [2022]