Oxaliplatin Infusions for Gastrointestinal Cancers

2 Versus 6 Hour Oxaliplatin Infusions in Patients With Gastrointestinal Cancers

Recruiting Phase 2 Interventional Study
Malignant Digestive System Neoplasm
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Emory University · Other
Who this trial is looking for

This trial is looking for patients with gastrointestinal cancers to test a longer way of giving oxaliplatin, a chemotherapy drug. Participants may benefit from reduced nerve damage and keep up with their cancer treatment. They will receive oxaliplatin over 6 hours instead of the regular time.

Are You a Good Fit for This Trial?
Rules you out Severe neuropathySevere heart diseaseSevere infectionSevere liver disease

You may be able to join if

  • I have a confirmed diagnosis of a gastrointestinal cancer.
  • I can complete 4 or more cycles of FOLFOX6 chemotherapy.
  • I have measurable disease that can be evaluated.
  • I have a performance status of 0-2.
  • My absolute neutrophil count is at least 1,500/µL.
  • My platelets are at least 75,000/µL.
  • My hemoglobin is at least 8 g/dL.
  • I can give signed informed consent.

You may not be able to join if

  • I have preexisting severe nerve damage.
  • I have received any cancer treatment in the past 14 days.
  • I am allergic to any part of FOLFOX6 chemotherapy.
  • I have uncontrolled severe medical conditions.
  • I have a history of serious bleeding requiring 4 or more blood transfusions.
  • I have been non-compliant in past medical treatments.
  • I am pregnant or nursing.
  • I cannot use effective birth control during the trial.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About 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 dos…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Confirmed diagnosis of a gastrointestinal cancer * Plan for 4 or more cycles of FOLFOX6 (fluorouracil \[with leucovorin\] and oxaliplatin) containing chemotherapy * Histologically confirmed, measurable or evalu…
Contacts

Olumide B. Gbolahan, MBBS, MSc

404-778-0032

ogbolah@emory.edu

CONTACT

Amber Draper, PharmD

amber.draper@emoryhealthcare.org

CONTACT