A study of lapatinib in combination with oxaliplatin and capecitabine in early HER-2 overexpressing oesophageal and gastric cancers - LEO (Lapatinib in Early Oesophago-gastric Cancer)

Phase 1

• Conditions: Oesophagogastric adenocarcinoma; MedDRA version: 8.1 Level: LLT Classification code 10017758 Term: Gastric cancer; MedDRA version: 9.1 Level: LLT Classification code 10001173 Term: Adenocarcinoma of the oesophagus

• Registration Number: EUCTR2010-019602-16-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-29
• Study Completion: 2015-03-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Histologically confirmed gastric or oesophageal adenocarcinoma

HER-2 3+ on IHC OR HER-2 2+ on IHC but shown to have HER-2 amplification by FISH

Decision to treat with curative intent

Deemed to require chemotherapy prior to surgery using standard management algorithms

Ability to swallow oral medication

Baseline 18FDG PET/CT scan showing no evidence of distant metastases

Adequate haematological, renal and hepatic function (Hb = 9.0 g/dL, WBC =3.0 x 109/L, Neutrophils = 1.0 x 109/L, Plt = 100 x 109/L; Measured or calculated creatinine clearance =60 ml/min; ALP = 2.5 x ULN, ALT = 1.5 x ULN and Bilirubin = 1.5 x ULN

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Advanced disease not amenable to surgery

Previous diagnosis of malignancy (excluding adequately treated Cervical carcinoma in situ or Basal cell carcinoma of the skin)

Abnormal Cardiac function (LVEF below normal as measured by echocardiogram or MUGA scan)

Inability to give informed consent

Hypersensitivity to lapatinib

Prior treatment with chemotherapy or lapatinib or other specific anticancer therapy
Squamous cell carcinomas, unclear differentiation type, sarcomas, carcinoid or GIST

Pregnancy/breastfeeding

Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified