Oxaliplatin Pharmacokinetics With and Without Ca2+/MG2+ Infusion in Colorectal Cancer Patients
1 other identifier
interventional
15
1 country
1
Brief Summary
The investigators hypothesize that Ca2+/MG2+ infusions will not have a significant effect on oxaliplatin pharmacokinetics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2015
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2010
CompletedFirst Posted
Study publicly available on registry
July 5, 2010
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 1, 2014
September 1, 2014
8 months
July 2, 2010
September 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective of this study is to determine potential pharmacokinetic interactions between oxaliplatin and calcium and magnesium.
Post cycle 2 and 3
Study Arms (2)
Ca2+/Mg2+ pre & post cycle 1
ACTIVE COMPARATORArm A:Ca2+/Mg2+: Ca++gluconate 1gr \& Mg++sulfate 1g given IV pre \& post cycle 1
Ca2+/Mg2+pre & post cycle 2
ACTIVE COMPARATORArm B:Ca2+/Mg2+: Ca++gluconate 1gr \& Mg++sulfate 1g given IV pre \& post cycle 2
Interventions
FOLFOX 6: Oxaliplatin (Eloxatin®): 100mg/m2 x 2hrs IV with 250ml of dextrose 5%; leucovorin 200mg/m2 with oxaliplatin; then IV bolus of 5FU 400mg/m2 and 5FU 2400mg/m2 in a 46 hr continuous IV. Each cycle is 14 days, approximately 8-12 cycles planned. XELOX: Oxaliplatin 130mg/m2 x 2hrs IV in 250ml of dextrose 5% on day 1; plus oral capecitabine 1000mg/m2 bid on days 1-15 3 wk cycles. Ca2+/Mg2: Ca++gluconate 1gr \& Mg++sulfate 1g given IV pre \& post cycle 1 (Arm A) or cycle 2 (Arm B)
Eligibility Criteria
You may qualify if:
- Patients must have Metastatic Colorectal Cancer (stage IV)
- Patients who were treated with 5FU and leucovorin in the adjuvant setting or with 5FU and leucovorin (LV)or/and FOLFIRI regimen for metastatic setting may be eligible for this trial.
- Patients must be ≥ 18 years
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients must have adequate renal function of creatinine \< 1.5mg/dl and a creatinine clearance \> 45ml/min. Patients must have adequate hepatic function with a bilirubin \> 1.5 mg/dl and AST (normal range 0-14/L) and ALT (normal range 0-49 U/L) in the absence of liver metastasis or \</= 5X the upper limit of normal of AST and ALT in the presence of liver metastasis.
- Patients must have adequate bone marrow function with absolute neutrophil count(ANC)≥ 1,500/цl and platelets ≥ 100,000/цl and a hemoglobin ≥ 10g/d.
- Patients must be willing and able to comply with the study protocol for the study duration and patients must give written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Also,women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. The investigator is requested to advise the patient how to achieve an adequate contraception.
- Life expectancy longer that 6 months
You may not qualify if:
- Patients who have received oxaliplatin previously
- Patients with known peripheral neuropathy ≥ grade 2 according to the WHO scale
- Patients who have tested positive for HIV
- Patients with other significant medical, psychiatric disorders tha, in the opinion of the investigator, will exclude the patient from the study for compliance of safety reasons.
- Patients who cannot swallow
- History of known allergy to oxaliplatin or other platinum compounds,to 5-FU, to LV, or to any ingredients in the formulations or the containers
- Participation in another clinical trial with any investigational drug within 30 days prior to study screening
- Pernicious anemia or other megaloblastic anemia with vitamin B12 deficiency
- Patient with concomitant treatment with drugs/ingredients reported to have a potential activity to prevent peripheral sensory neuropathy (PSN)
- Patients who haven't successfully completed local therapy for previously treated CNS metastases \& who haven't been discontinued with corticosteroid for \>4kws before starting chemotherapy. Patients with asymptomatic brain mets who have no evidence of midline shift on CT/MRI may be enrolled without initiation of local therapy for the CNS mets. Repeat scan must be performed \< 4wks to ensure no progression.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Michael Sawyer, MD
Alberta Health services
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2010
First Posted
July 5, 2010
Study Start
January 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 1, 2014
Record last verified: 2014-09