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Dose Escalation Study of Lithium With Oxaliplatin and Capecitabine in Advanced Oesophago-Gastric or Colorectal Cancer

NCT03153280 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-07-08

No results posted yet for this study

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 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.

Conditions

  • Colorectal Neoplasms
  • Stomach Neoplasm
  • Esophageal Neoplasms

Interventions

DRUG

Lithium

Dose escalation of Lithium to determine the maximum tolerated dose (MTD)

DRUG

Oxaliplatin

Dose as used in standard of care - 130 mg/m2.

DRUG

Capecitabine

Dose as used in standard of care - 800 - 1000 mg/m2

Sponsors & Collaborators

  • University College Cork

    collaborator OTHER

  • Cancer Trials Ireland

    lead NETWORK

Principal Investigators

  • Cancer Trials Ireland Dublin 11, Ireland · Cancer Trials Ireland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2023-09-07
Completion
2023-09-07

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03153280 on ClinicalTrials.gov