A study of lapatinib in combination with oxaliplatin and capecitabine in oesophageal and gastric cancers

Phase 4

Completed

• Conditions: pper Gastro-Intestinal Cancer; Oesophagus, Stomach; Cancer; Malignant neoplasm of oesophagus and stomach

• Registration Number: ISRCTN49623344
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26484410 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-27
• Study Completion: 2015-07-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Histologically confirmed gastric or oesophageal adenocarcinoma
2. Human Epidermal growth factor Receptor 2 (HER-2) 3+ on IHC OR HER-2 2+ on IHC but shown to have HER-2 amplification by (Fluorescent In-Situ Hybridization) FISH
3. Decision to treat with curative intent
4. Deemed to require chemotherapy prior to surgery using standard management algorithms
5. Ability to swallow oral medication
6. Baseline 18FDG PET/CT scan showing no evidence of distant metastases
7. Adequate haematological parameters: ANC = 1.0 x 109/L; WBC = 3.0 x 109/L; Plt = 100 x 109/L; haemoglobin (Hb) = 9g/dL (can be post-transfusion)
8. Adequate renal function (Measured or calculated creatinine clearance = 60 ml/min- if calculated the Cockcroft-Gault equation (Appendix A) to be used
9. Adequate liver function: serum Bilirubin = 1.5 x ULN; ALT/AST = 1.5 x ULN; ALP = 2.5 x ULN
10. Age >18 years
11. Women of child bearing potential using medically approved contraception (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential)
12. Male patients using barrier contraceptives during the trial and for 6 months after the completion of the trial
13. Target gender: male & female
14. Lower age limit 18 years

Exclusion Criteria

1. Advanced disease not amenable to surgery
2. Previous diagnosis of malignancy (excluding adequately treated Cervical carcinoma in situ or Basal cell carcinoma of the skin)
3. Abnormal Cardiac function (LVEF below normal as measured by echocardiogram or MUGA scan)
4. History of clinically significant cardiac disease e.g. symptomatic coronary artery disease, uncontrolled cardiac dysrhythmia or myocardial infarction within the last 12 months)
5. History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan
6. Known peripheral neuropathy >Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
7. Inability to give informed consent
8. Hypersensitivity to lapatinib or oxaliplatin or capecitabine
9. Prior treatment with chemotherapy or lapatinib or other specific anticancer therapy
10. Squamous cell carcinomas, unclear differentiation type, sarcomas, carcinoid or GIST
11. Known positive tests for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
12. Pregnancy/breastfeeding
13. 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)
14. Treatment with another investigational agent within 30 days of commencing study treatment
15. Known or suspected dihydropyrimidine dehydrogenase deficiency (DPD)
16. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Study & Design

• Study Type: Interventional
• Study Design: Not specified