Neoplasms, ColorectalPhase 1NCT01157052
Oxaliplatin Pharmacokinetics With and Without Ca2+/MG2+ Infusion in Colorectal Cancer Patients
A Phase 1 study testing (supplement) Calcium and Magnesium in people with Neoplasms, Colorectal and Colorectal Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The investigators hypothesize that Ca2+/MG2+ infusions will not have a significant effect on oxaliplatin pharmacokinetics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Colorectal, Colorectal Cancer, Colorectal Carcinoma
- What is being tested?
- (supplement) Calcium and Magnesium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Judith Meza-Junco, MD
About this study
The investigators hypothesize that Ca2+/MG2+ infusions will not have a significant effect on oxaliplatin pharmacokinetics.
Read the 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.
- Being tested
- (supplement) Calcium and Magnesium
- Keywords
- magnesium, calcium, adverse effects, kinetics, drug
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(supplement) Calcium and MagnesiumOther
Also called oxaliplatin= eloxatin, Capecitabine=Xeloda
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)
| Study group | Role | What they receive |
|---|---|---|
| Ca2+/Mg2+ pre & post cycle 1 | Active comparator | Arm A:Ca2+/Mg2+: Ca++gluconate 1gr \& Mg++sulfate 1g given IV pre \& post cycle 1 Receives: Other: (supplement) Calcium and Magnesium |
| Ca2+/Mg2+pre & post cycle 2 | Active comparator | Arm B:Ca2+/Mg2+: Ca++gluconate 1gr \& Mg++sulfate 1g given IV pre \& post cycle 2 Receives: Other: (supplement) Calcium and Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to determine potential pharmacokinetic interactions between oxaliplatin and calcium and magnesium.
Measured: Post cycle 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startJan 2015
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, ColorectalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Sawyer, MD, Study chair, Alberta Health services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157052
- Sponsor's protocol ID
- 25408
- Status last verified
- Sep 2014
- First submitted
- 2 Jul 2010
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxaliplatin Pharmacokinetics With and Without Ca2+/MG2+ Infusion in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT01157052
- Acronym / sponsor ID
- 25408
- Keywords
- magnesium, calcium, adverse effects, kinetics, drug
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ca2+/Mg2+ pre & post cycle 1 | Active comparator | Other: (supplement) Calcium and MagnesiumArm A:Ca2+/Mg2+: Ca++gluconate 1gr \& Mg++sulfate 1g given IV pre \& post cycle 1 |
| Ca2+/Mg2+pre & post cycle 2 | Active comparator | Other: (supplement) Calcium and MagnesiumArm B:Ca2+/Mg2+: Ca++gluconate 1gr \& Mg++sulfate 1g given IV pre \& post cycle 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (supplement) Calcium and MagnesiumAlso: oxaliplatin= eloxatin, Capecitabine=XelodaFOLFOX 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 | Ca2+/Mg2+ pre & post cycle 1, Ca2+/Mg2+pre & post cycle 2 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sawyer, MD study chair
Alberta Health services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing (supplement) Calcium and Magnesium in people with Neoplasms, Colorectal and Colorectal Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Sawyer, MD (780-432-8248, Michael.Sawyer@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.