RECRUITING

2 Versus 6 Hour Oxaliplatin Infusions in Patients with Gastrointestinal Cancers

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase II Evaluation of the Effect of 2 Versus 6 Hour Oxaliplatin Infusions on Neuropathy and Pharmacokinetics in Patients with Gastrointestinal Cancers

Quick Facts

Study Start:2019-03-14

Study Completion:2026-09-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03800693

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Olumide B. Gbolahan, MBBS, MSc

CONTACT

404-778-0032

ogbolah@emory.edu

Amber Draper, PharmD

CONTACT

amber.draper@emoryhealthcare.org

Principal Investigator

Olumide B. Gbolahan, MBBS, MSc

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

United States

Collaborators and Investigators

Sponsor: Emory University

Olumide B. Gbolahan, MBBS, MSc, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-14

Study Completion Date2026-09-17

Study Record Updates

Study Start Date2019-03-14

Study Completion Date2026-09-17

Terms related to this study

Additional Relevant MeSH Terms

Malignant Digestive System Neoplasm