A randomized, placebo-controlled, double-blind phase II study evaluating if Glucophage can avoid Liver injury due to Chemotherapy Associated Steatosis.

A randomized, placebo-controlled, double-blind multicenter phase II study to investigate the protectivity and efficacy of Metformin against steatosis in combination with FOLFIRI and Cetuximab in subjects with first-line palliative treated, KRAS-Wild-Type, metastatic colorectal cancer - G-LUCAS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001010-34-AT

Enrollment

132

Registered

2011-05-16

Start date

2011-11-08

Completion date

Unknown

Last updated

2014-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

first-line palliative treated, KRAS-Wild-Type, metastatic colorectal cancer

Interventions

Trade Name: Glucophage Pharmaceutical Form: Film-coated tablet INN or Proposed INN: METFORMIN HYDROCHLORIDE CAS Number: 1115-70-4 Concentration unit: mg milligram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Signed written informed consent • Male or female >= 18 years of age • Diagnosis of histologically confirmed, KRAS “wild-type” adenocarcinoma of the colon or rectum • Non-resectable metastatic colorectal carcinoma • Either presence of at least one liver lesion measurable unidimensionally by CT scan or MRI or at least one resectable liver metastasis with non-resectable extrahepatic disease (as assessed within 3 weeks prior to randomisation) • Subjects scheduled to receive cetuximab and FOLFIRI • ECOG performance status of 0 - 1 at study entry • Leukocytes >= 3.0 x 10^9/L and neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, and hemoglobin >= 8 g/dL • Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 132

Exclusion criteria

Exclusion criteria: • Brain metastasis (if suspected, brain scan indicated) • Previous chemotherapy for the currently existing metastatic disease • Known or newly diagnosed diabetes • Patients with ACS within the last three months • Stage 3 or 4 heart failure defined according to the NYHA criteria • Uncontrolled angina • Contraindications to metformin (renal impairment [eGFR = 5 years will be allowed to enter the trial) • Pregnancy or lactation • Inadequate contraception (male or female patients) if of childbearing or procreative potential • Known drug abuse/ alcohol abuse • Legal incapacity or limited contractual capacity Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: Reduction in chemo-therapy associated steatosis in subjects with first-line palliative treatment of metastatic colorectal cancer;Secondary Objective: - To evaluate the safety and tolerability of metformin in combination with FOLFIRI and cetuximab as first line therapy for KRAS wild-type mCRC by recording the adverse events and abnormal laboratory values associated with the study treatments. - To assess the efficacy of of metformin in combination with FOLFIRI and cetuximab as first line therapy for KRAS wild-type mCRC with respect to tumour response rate, progression free survival and overall survival. - Reduction in chemo-therapy associated steatohepatitis in subjects with first-line palliative treatment of mCRC ;Primary end point(s): Reduction in the chemotherapy-associated steatosis, as assessed by the steatosis subcore of NAFLD activity score (NAS);Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after the last treatment visit	—

Measure

Time frame

Main Objective: Reduction in chemo-therapy associated steatosis in subjects with first-line palliative treatment of metastatic colorectal cancer;Secondary Objective: - To evaluate the safety and tolerability of metformin in combination with FOLFIRI and cetuximab as first line therapy for KRAS wild-type mCRC by recording the adverse events and abnormal laboratory values associated with the study treatments. - To assess the efficacy of of metformin in combination with FOLFIRI and cetuximab as first line therapy for KRAS wild-type mCRC with respect to tumour response rate, progression free survival and overall survival. - Reduction in chemo-therapy associated steatohepatitis in subjects with first-line palliative treatment of mCRC ;Primary end point(s): Reduction in the chemotherapy-associated steatosis, as assessed by the steatosis subcore of NAFLD activity score (NAS);Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after the last treatment visit

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Secondary

Measure	Time frame
Secondary end point(s): • Progression free survival (PFS) • Overall survivial (OS) • Safety / Adverse events (all subjects received at least one dose of IMP) • Objective response rate (CR/PR), as assessed by RECIST criteria, version 1.1 • Reduction in chemo-therapy associated steatohepatitis (CASH) as assessed by NAS;Timepoint(s) of evaluation of this end point: • PFS and OS will be evaluated after final study visits. Subjects who terminate the study before their scheduled final study visits will be censored. • Safety outcomes will be evaluated after the last treatment visit, adverse events will be evaluated after the final study visit. Additional safety analyses of reported AEs will be performed after the evaluation of 20 and 54 patients (between the 2 treatment groups) at the time of interim analysis. • The objective response rate and the reduction in NAS will be evaluated after the last treatment visit.	—

Measure

Time frame

Secondary end point(s): • Progression free survival (PFS) • Overall survivial (OS) • Safety / Adverse events (all subjects received at least one dose of IMP) • Objective response rate (CR/PR), as assessed by RECIST criteria, version 1.1 • Reduction in chemo-therapy associated steatohepatitis (CASH) as assessed by NAS;Timepoint(s) of evaluation of this end point: • PFS and OS will be evaluated after final study visits. Subjects who terminate the study before their scheduled final study visits will be censored. • Safety outcomes will be evaluated after the last treatment visit, adverse events will be evaluated after the final study visit. Additional safety analyses of reported AEs will be performed after the evaluation of 20 and 54 patients (between the 2 treatment groups) at the time of interim analysis. • The objective response rate and the reduction in NAS will be evaluated after the last treatment visit.

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Countries

Austria

Contacts

Public ContactStudienzentrale (Trial Office)

ABCSG (Austrian Breast & Colorectal Cancer Study Group)

info@abcsg.at+4314089230

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026