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 outSevere 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.
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…
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.
Trial Locations
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City
State
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Status
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…
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 evaluable disease. Patients with advanced or metastatic disease should have at least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients in the adjuvant treatment setting planned to have \> 4 cycles of FOLFOX-containing chemotherapy are eligible and will be followed per standard of care
* Absolute neutrophil count (ANC) ≥ 1,500/µL (no white blood cell growth factors allowed to meet requirement)
* Platelets ≥ 75,000/µL (may be transfused up to 72 hours prior to day 1 to meet requirement)
* Hemoglobin ≥ 8 g/dL (may be transfused up to 72 hours prior to day 1 to meet requirement)
* Creatinine clearance \> 30 mL/min by Cockcroft-Gault, to preserve similar dosing (85 mg/m²) for analysis
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Signed informed consent
* Adequate birth control when appropriate
Exclusion Criteria:
* Any preexisting grade 2 or higher peripheral neuropathy
* Patients currently receiving anticancer therapies or who have received any focal or systemic anticancer therapy within 14days of the start of FOLFOX6
* Known intolerance or hypersensitivity to any agent in FOLFOX6 or concurrent agents
* Patients who have any known severe and/or uncontrolled medical conditions such as:
* Unstable angina pectoris, symptomatic heart failure; (New York Heart Association class III or IV), myocardial infarction ≤ 6 months prior, serious uncontrolled cardiac arrhythmia, or any other clinically significant cardiac disease
* Active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, or decompensated liver disease
* Patients with any history of severe hemorrhage requiring ≥ 4 units of packed red blood cells (RBCs) in a 48-hour period
* Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
* Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 14days prior to dosing
* Pregnant or nursing (lactating) women
* Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after. Highly effective contraception methods include combination of any two of the following:
* Use of oral, injected or implanted hormonal methods of contraception or;
* Placement of an intrauterine device (IUD) or intrauterine system (IUS);
* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository;
* Total abstinence or;
* Male/female sterilization Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential
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