Colorectal NeoplasmsPhase 1LithiumNCT03153280
Dose Escalation Study of Lithium With Oxaliplatin and Capecitabine in Advanced Oesophago-Gastric or Colorectal Cancer
A Phase 1 study testing Lithium, Oxaliplatin and Capecitabine in people with Colorectal Neoplasms and Stomach Neoplasm, run by Cancer Trials Ireland at 2 sites in Ireland.
Trial summary
This study is a phase Ib, open label, multi-centre trial designed to estimate the Maximum Tolerated Dose (MTD) of lithium when combined with a standard chemotherapy regimen of oxaliplatin and capecitabine in patients with advanced, unresectable, oesophago-gastric or colorectal cancer who have received no previous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Stomach Neoplasm, Esophageal Neoplasms
- What is being tested?
- Lithium, Oxaliplatin and Capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesIreland
- Study dates
- 13 Jan 2022to 7 Sep 2023
- 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
- Written informed consent must be given according to ICH/GCP and national/local regulations, and be obtained prior to any study-related procedures.
- Histologically or cytologically confirmed adenocarcinoma of the colon, rectum, stomach, gastro-oesophageal junction or lower third of the oesophagus.
- Metastatic disease not amenable to surgical resection with curative intent.
- Eastern Co-operative Oncology Group (ECOG) performance status 2 (Appendix B).
- Age ≥ to 18.
- Estimated life expectancy ≥ 3 months.
Show all 13Show fewer
- Measurable disease, defined as at least 1 uni-dimensionally measurable lesion on a CT scan as defined by RECIST criteria, Version 1.1 (Appendix F).
- Adequate haematological, hepatic, and renal function defined as:
- Renal: i. Calculated creatinine clearance (CrCl) 50ml/min (see Appendix G) b. Liver function tests: i. Total Bilirubin ≤ ULN ii. ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN with liver involvement of their cancer) iii. Alkaline Phosphatase ≤ 2.5 x ULN (≤ 5 x ULN with liver involvement of their cancer) c. Haematology: i. Haemoglobin 9.0 g/dL for females and 10.0 g/dL for males ii. Absolute neutrophil count 1.5 x 109/L iii. Platelet count 100 x109/L
- Normal thyroid function (TSH 0.4-3.5mUL).
- Able to swallow and retain oral medication.
- Women of child-bearing potential and male patients must agree to use adequate contraception for the duration of study participation and for up to 3 months following discontinuation of therapy. Adequate contraception is defined as any medically recommended (or combination of methods) as per standard of care.
- Women of child bearing potential must have pregnancy excluded by urine or serum beta-HCG testing within 7 days prior to registration.
Who cannot join
- Received prior chemotherapy for metastatic disease. (Patients who received prior adjuvant or neo-adjuvant chemotherapy or definitive radio-chemotherapy for localised disease are eligible if the chemotherapy has stopped at least 6 months before registration).
- Previous or concurrent malignancy within the past 5 years, with the exception of basal cell carcinoma of the skin or in-situ neoplasia of the uterine cervix or bladder.
- Brain or other Central Nervous System (CNS) metastases.
- Known di-hydropyrimidine dehydrogenase (DPD) deficiency.
- Screening electrocardiogram (ECG) with evidence of:
- QT prolongation (QTc > 450 ms in males and > 470 ms in females)
Show all 27Show fewer
- 2nd or 3rd degree heart block
- Other severe cardiac dysfunction (ECG must be assessed for all patients within 14 days prior to registration)
- Clinically significant cardiovascular disease including:
- Cerebrovascular accident within 6 months prior to registration
- Myocardial infarction within 6 months prior to registration
- Uncontrolled angina
- Uncontrolled hypertension
- Clinically significant valvular disease
- Congestive Heart Failure (NYHA Class 2) (See Appendix E).
- Severe chronic obstructive pulmonary disease (COPD) > Grade 2 according to NCI CTCAE v4.0.
- Known history or family history of Brugada Syndrome.
- Symptoms or signs of peripheral neuropathy.
- Ongoing infection > Grade 2 according to NCI CTCAE v4.0.
- Seizure disorder requiring medication.
- Dehydration Grade 1 according to NCI CTCAE v4.0; patients on Low sodium diet; Addison's disease.
- Known hypersensitivity to lithium, oxaliplatin or fluoropyrimidines.
- Pregnant or nursing women.
- Concurrent treatment with any other investigational agents within 30 days prior to registration.
- Any psychological, physical, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; (those conditions should be discussed with the patient before registration in the trial).
- Unable or unwilling to discontinue (and substitute if necessary) use of prohibited medications for at least 30 days prior to and for the duration of study treatment (see section 7.5 for a description of prohibited medications).
- Patients weighing less than 50kg.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase Ib, Dose Escalation Study of Lithium When Added to Standard Chemotherapy of Oxaliplatin and Capecitabine in Patients With Advanced Oesophago-Gastric or Colorectal Cancer
This study is a phase Ib, open label, multi-centre trial designed to estimate the Maximum Tolerated Dose (MTD) of lithium when combined with a standard chemotherapy regimen of oxaliplatin and capecitabine in patients with advanced, unresectable, oesophago-gastric or colorectal cancer who have received no previous treatment for advanced disease (previous adjuvant or neo-adjuvant treatment is acceptable if completed at least 6 months prior to registration).
The study follows a modified Fibonacci, 3+3, dose escalation design. Patients are enrolled in cohorts of 3. All three patients in each cohort must complete at least two cycles of treatment to be evaluable for toxicity. If a patient cannot complete 2 cycles, another patient will be enrolled.
Read the detailed description
This study is a Phase Ib, open label, multi-centre, dose escalation trial to assess the dose of lithium that can be safely combined with standard treatment oxaliplatin and capecitabine chemotherapy.
Registered patients will be treated with lithium combined with a standard chemotherapy regimen of oxaliplatin and capecitabine until a maximum of 6 x 21 day cycles (18 weeks), tumour progression, unacceptable toxicity, pregnancy, withdrawal of consent or withdrawal at the discretion of the investigator, whichever occurs first.
After discontinuation of study treatment, all patients will be followed for safety for at least 30 days.
Patients who discontinue treatment for reasons other than disease progression will continue to be followed every 9 weeks in accordance with standard of care for efficacy (i.e. tumour assessment) until disease progression, death, withdrawal of consent, loss to follow up or until the start of a new anti-neoplastic treatment, whichever occurs first.
Once the patient has documented disease progression, they will be followed up every three months (±1 month) for survival status.
The trial will be a traditional 3+3 design: cohorts of 3 patients will be treated with lithium combined with standard treatment oxaliplatin and capecitabine chemotherapy.
The doses of oxaliplatin and capecitabine have been established in prior phase II and III studies and will not be escalated. Lithium target serum concentrations are assigned at registration according to a defined dose escalation scheme. Study lithium dose escalation will follow a modified Fibonacci 3+3 sequence.
A -1 dose level (0.4mmol/L) is included in case dose de-escalation is needed.
The levels of lithium achieved in each patient will be established by regular assessment of steady state serum concentrations.
Lithium will start at a low level and dose escalations will be performed in cohorts of 3 patients according to a standard 3+3 algorithm.
Dose escalation and determination of MTD will be based on the occurrence of Dose Limiting Toxicities (DLT) as defined below.
The first cohort of 3 patients will commence at dose level 1. All patients in each cohort will be observed for two cycles on the specified dose:
- If none of 3 patients at a given dose level experiences a DLT, accrual will continue to the next dose level according to the protocol.
- If 1 of 3 patients experiences a DLT at a given dose level, 3 additional patients will be treated at the same dose. If no additional patient has a DLT in this cohort, accrual will continue to the next dose level according to the protocol.
- If 2 or more patients in 3 or 6 patients treated at a given dose experience a DLT, the next lowest dose level will define the MTD.
A Dose Limiting Toxicity (DLT) is defined as any of the following adverse events occurring during the two first cycles (within 42 days from first dose) of treatment and possibly, probably or definitely related to the combination of lithium, oxaliplatin and capecitabine:
- Grade 3 or 4 non-haematological toxicity other than nausea, vomiting or fatigue.
- Grade 3 or 4 thrombocytopenia: grade 4 thrombocytopenia (platelet count < 25 x 109/L) or grade 3/4 thrombocytopenia (grade 3 platelet count: 25 x 109/L to < 50 x 109/L) associated with bleeding.
- Complicated grade 4 neutropenia (< 0.5 x 109/L): fever, sepsis > 5 days of duration.
- Any significant* grade 2 and higher toxicity other than nausea, vomiting, rash, alopecia or anaemia that persists longer than 35 days after the start of cycle 1.
*"Significant" defined as affecting quality of life or patient safety as determined by investigator.
Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity of study therapy. Safety assessments will be performed every 3 weeks for the 18 weeks. Efficacy assessments (Radiological examination) will be performed on all patients every 9 weeks (+/- 1 week).
An End of Treatment visit will be performed for patients within 30 days (+/- 1 week) post last dose or disease progression.
- Conditions
- Colorectal Neoplasms, Stomach Neoplasm, Esophageal Neoplasms
- Being tested
- Lithium, Oxaliplatin, Capecitabine
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
Dose escalation of Lithium to determine the maximum tolerated dose (MTD)
OxaliplatinDrug
Dose as used in standard of care - 130 mg/m2.
CapecitabineDrug
Dose as used in standard of care - 800 - 1000 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Lithium, Oxaliplatin & Capecitabine | Experimental | Target serum concentrations of escalating doses of lithium (0.6, 0.9, 1.26 or 1.4 mmol/L) in combination standard chemotherapy - oxaliplatin and capecitabine. Receives: Drug: Lithium; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT) within the two first cycles at each dose level.
The MTD will be based on the incidence of DLT within the two first cycles of lithium in combination with standard chemotherapy of oxaliplatin and capecitabine at each dose level.
Measured: 26 months
Secondary outcomes (3)
Progression Free Survival (PFS) as defined by RECIST Criteria Version 1.1.
PFS will be defined as the time from the start of treatment until disease progression or death as a result of any cause.
Measured: 3 years
Objective Response Rate (ORR) as defined by RECIST Criteria Version 1.1.
ORR is defined as the proportion of patients who receive a Complete Response or a Partial Response (CR + PR).
Measured: 3 years
Incidence of adverse events reported as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. (Safety and Tolerability).
Safety will be assessed by standard clinical and laboratory tests.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start13 Jan 2022
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Why it stopped: Poor accrual and the field has moved on.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Lithium: starting dose: 2x 400mg p.o. per day. Initial target blood concentration (Level 1 = 0.6mmol/L). Oxaliplatin: 130 mg/m2 in 500 ml normal saline (NS) over 120 minutes on Day 1 of each 3 week cycle. Capecitabine: 1000 mg/m2 b.i.d po on Days 1 to 14 of each 3 week cycle.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Collaborators
- University College Cork
- Responsible party
- Sponsor
- Investigators
- Cancer Trials Ireland Dublin 11, Ireland, Study director, Cancer Trials Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153280
- Sponsor's protocol ID
- CTRIAL-IE (ICORG) 11-32
- Other IDs
- 2014-000186-47, 2014
- Acronym
- Lithium
- Status last verified
- Jul 2025
- First submitted
- 10 May 2017
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Dose Escalation Study of Lithium When Added to Standard Chemotherapy of Oxaliplatin and Capecitabine in Patients With Advanced Oesophago-Gastric or Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03153280
- Acronym / sponsor ID
- Lithium / CTRIAL-IE (ICORG) 11-32
- Conditions
- Colorectal Neoplasms, Stomach Neoplasm, Esophageal Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual and the field has moved on.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Collaborators
- University College Cork
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 15 May 2017 (actual)
- 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.
This study is a phase Ib, open label, multi-centre trial designed to estimate the Maximum Tolerated Dose (MTD) of lithium when combined with a standard chemotherapy regimen of oxaliplatin and capecitabine in patients with advanced, unresectable, oesophago-gastric or colorectal cancer who have received no previous treatment for advanced disease (previous adjuvant or neo-adjuvant treatment is acceptable if completed at least 6 months prior to registration).
The study follows a modified Fibonacci, 3+3, dose escalation design. Patients are enrolled in cohorts of 3. All three patients in each cohort must complete at least two cycles of treatment to be evaluable for toxicity. If a patient cannot complete 2 cycles, another patient will be enrolled.
Detailed description
This study is a Phase Ib, open label, multi-centre, dose escalation trial to assess the dose of lithium that can be safely combined with standard treatment oxaliplatin and capecitabine chemotherapy.
Registered patients will be treated with lithium combined with a standard chemotherapy regimen of oxaliplatin and capecitabine until a maximum of 6 x 21 day cycles (18 weeks), tumour progression, unacceptable toxicity, pregnancy, withdrawal of consent or withdrawal at the discretion of the investigator, whichever occurs first.
After discontinuation of study treatment, all patients will be followed for safety for at least 30 days.
Patients who discontinue treatment for reasons other than disease progression will continue to be followed every 9 weeks in accordance with standard of care for efficacy (i.e. tumour assessment) until disease progression, death, withdrawal of consent, loss to follow up or until the start of a new anti-neoplastic treatment, whichever occurs first.
Once the patient has documented disease progression, they will be followed up every three months (±1 month) for survival status.
The trial will be a traditional 3+3 design: cohorts of 3 patients will be treated with lithium combined with standard treatment oxaliplatin and capecitabine chemotherapy.
The doses of oxaliplatin and capecitabine have been established in prior phase II and III studies and will not be escalated. Lithium target serum concentrations are assigned at registration according to a defined dose escalation scheme. Study lithium dose escalation will follow a modified Fibonacci 3+3 sequence.
A -1 dose level (0.4mmol/L) is included in case dose de-escalation is needed.
The levels of lithium achieved in each patient will be established by regular assessment of steady state serum concentrations.
Lithium will start at a low level and dose escalations will be performed in cohorts of 3 patients according to a standard 3+3 algorithm.
Dose escalation and determination of MTD will be based on the occurrence of Dose Limiting Toxicities (DLT) as defined below.
The first cohort of 3 patients will commence at dose level 1. All patients in each cohort will be observed for two cycles on the specified dose:
- If none of 3 patients at a given dose level experiences a DLT, accrual will continue to the next dose level according to the protocol.
- If 1 of 3 patients experiences a DLT at a given dose level, 3 additional patients will be treated at the same dose. If no additional patient has a DLT in this cohort, accrual will continue to the next dose level according to the protocol.
- If 2 or more patients in 3 or 6 patients treated at a given dose experience a DLT, the next lowest dose level will define the MTD.
A Dose Limiting Toxicity (DLT) is defined as any of the following adverse events occurring during the two first cycles (within 42 days from first dose) of treatment and possibly, probably or definitely related to the combination of lithium, oxaliplatin and capecitabine:
- Grade 3 or 4 non-haematological toxicity other than nausea, vomiting or fatigue.
- Grade 3 or 4 thrombocytopenia: grade 4 thrombocytopenia (platelet count < 25 x 109/L) or grade 3/4 thrombocytopenia (grade 3 platelet count: 25 x 109/L to < 50 x 109/L) associated with bleeding.
- Complicated grade 4 neutropenia (< 0.5 x 109/L): fever, sepsis > 5 days of duration.
- Any significant* grade 2 and higher toxicity other than nausea, vomiting, rash, alopecia or anaemia that persists longer than 35 days after the start of cycle 1.
*"Significant" defined as affecting quality of life or patient safety as determined by investigator.
Clinical and laboratory parameters will be assessed to evaluate disease response and toxicity of study therapy. Safety assessments will be performed every 3 weeks for the 18 weeks. Efficacy assessments (Radiological examination) will be performed on all patients every 9 weeks (+/- 1 week).
An End of Treatment visit will be performed for patients within 30 days (+/- 1 week) post last dose or disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lithium: starting dose: 2x 400mg p.o. per day. Initial target blood concentration (Level 1 = 0.6mmol/L). Oxaliplatin: 130 mg/m2 in 500 ml normal saline (NS) over 120 minutes on Day 1 of each 3 week cycle. Capecitabine: 1000 mg/m2 b.i.d po on Days 1 to 14 of each 3 week cycle.
| Arm | Type | Receives |
|---|---|---|
| Lithium, Oxaliplatin & Capecitabine | Experimental | Drug: Lithium, Drug: Oxaliplatin, Drug: CapecitabineTarget serum concentrations of escalating doses of lithium (0.6, 0.9, 1.26 or 1.4 mmol/L) in combination standard chemotherapy - oxaliplatin and capecitabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent must be given according to ICH/GCP and national/local regulations, and be obtained prior to any study-related procedures.
- Histologically or cytologically confirmed adenocarcinoma of the colon, rectum, stomach, gastro-oesophageal junction or lower third of the oesophagus.
- Metastatic disease not amenable to surgical resection with curative intent.
- Eastern Co-operative Oncology Group (ECOG) performance status 2 (Appendix B).
- Age ≥ to 18.
Key exclusion criteria (27 listed)
- Received prior chemotherapy for metastatic disease. (Patients who received prior adjuvant or neo-adjuvant chemotherapy or definitive radio-chemotherapy for localised disease are eligible if the chemotherapy has stopped at least 6 months before registration).
- Previous or concurrent malignancy within the past 5 years, with the exception of basal cell carcinoma of the skin or in-situ neoplasia of the uterine cervix or bladder.
- Brain or other Central Nervous System (CNS) metastases.
- Known di-hydropyrimidine dehydrogenase (DPD) deficiency.
- Screening electrocardiogram (ECG) with evidence of:
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 |
|---|---|---|
| LithiumDose escalation of Lithium to determine the maximum tolerated dose (MTD) | Drug | Lithium, Oxaliplatin & Capecitabine |
| OxaliplatinDose as used in standard of care - 130 mg/m2. | Drug | Lithium, Oxaliplatin & Capecitabine |
| CapecitabineDose as used in standard of care - 800 - 1000 mg/m2 | Drug | Lithium, Oxaliplatin & Capecitabine |
Primary outcome
Incidence of dose limiting toxicity (DLT) within the two first cycles at each dose level.
Time frame: 26 months
The MTD will be based on the incidence of DLT within the two first cycles of lithium in combination with standard chemotherapy of oxaliplatin and capecitabine at each dose level.
3 secondary outcomes
Progression Free Survival (PFS) as defined by RECIST Criteria Version 1.1.
Time frame: 3 years
Objective Response Rate (ORR) as defined by RECIST Criteria Version 1.1.
Time frame: 3 years
Incidence of adverse events reported as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. (Safety and Tolerability).
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Poor accrual and the field has moved on.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Cancer Trials Ireland Dublin 11, Ireland study director
Cancer Trials Ireland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lithium, Oxaliplatin and Capecitabine in people with Colorectal Neoplasms and Stomach Neoplasm, run by Cancer Trials Ireland at 2 sites in Ireland.
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 13 inclusion and 27 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: stopped early, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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?
The study was stopped early (reason given: Poor accrual and the field has moved on.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLT) within the two first cycles at each dose level. (time frame: 26 months). 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 8 Jul 2025.