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Oxaliplatin Pharmacokinetics With and Without Ca2+/MG2+ Infusion in Colorectal Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157052
Recruitment Status : Unknown
Verified September 2014 by AHS Cancer Control Alberta.
Recruitment status was:  Not yet recruiting
First Posted : July 5, 2010
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Tracking Information
First Submitted Date  ICMJE July 2, 2010
First Posted Date  ICMJE July 5, 2010
Last Update Posted Date October 1, 2014
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2010)
The primary objective of this study is to determine potential pharmacokinetic interactions between oxaliplatin and calcium and magnesium. [ Time Frame: Post cycle 2 and 3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01157052 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Oxaliplatin Pharmacokinetics With and Without Ca2+/MG2+ Infusion in Colorectal Cancer Patients
Official Title  ICMJE Oxaliplatin Pharmacokinetics With and Without Ca2+/MG2+ Infusion in Colorectal Cancer Patients
Brief Summary The investigators hypothesize that Ca2+/MG2+ infusions will not have a significant effect on oxaliplatin pharmacokinetics.
Detailed Description This is a clinical pharmacology prospective non-randomized trial to determine oxaliplatin pharmacokinetics in the presence and absence of calcium and magnesium supplementation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Neoplasms, Colorectal
  • Colorectal Cancer
  • Colorectal Carcinoma
Intervention  ICMJE Other: (supplement) Calcium and Magnesium

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)

Other Name: oxaliplatin= eloxatin, Capecitabine=Xeloda
Study Arms  ICMJE
  • Active Comparator: Ca2+/Mg2+ pre & post cycle 1
    Arm A:Ca2+/Mg2+: Ca++gluconate 1gr & Mg++sulfate 1g given IV pre & post cycle 1
    Intervention: Other: (supplement) Calcium and Magnesium
  • Active Comparator: Ca2+/Mg2+pre & post cycle 2
    Arm B:Ca2+/Mg2+: Ca++gluconate 1gr & Mg++sulfate 1g given IV pre & post cycle 2
    Intervention: Other: (supplement) Calcium and Magnesium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 2, 2010)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01157052
Other Study ID Numbers  ICMJE 25408
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AHS Cancer Control Alberta
Study Sponsor  ICMJE AHS Cancer Control Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Michael Sawyer, MD Alberta Health Services
PRS Account AHS Cancer Control Alberta
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP