Metastatic pancreatic cancer MedDRA version: 9.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic
Conditions
Interventions
Trade Name: Tyverb
Product Name: Lapatinib
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lapatinib
CAS Number: 388082-78-8
Current Sponsor code: lapatinib
Concentration unit: mg millig
Sponsors
ICORG - the All-Ireland Cooperative Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients must have histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. • Patients may have measurable or non measurable disease. - Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > or = 20 mm with conventional techniques or as > or = 10 mm with spiral CT scan. • Patients may have received prior radiation therapy or surgery however toxicities must have resolved to NCI CTCAE or = 18 years. Because no dosing or adverse event data are currently available on the use of lapatinib in patients or = 1.5 x 10^9/L Haemoglobin > or = 9 g/dL Platelets > or = 100 x 10^9/L Hepatic Albumin > or = 2.5 g/dL Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients may not have received chemotherapy for locally advanced or metastatic pancreatic cancer. Patients may have received prior chemotherapy in the adjuvant setting. This therapy may have included treatment with 5-fluorouracil as a radiation sensitiser only. Patients must have a minimum treatment free interval of 3 months. • Patients who have had prior treatment with EGFR or ErbB2 targeting therapies. • Patients who have had prior treatment with Capecitabine are not permitted to enter the study. • Patients 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). • Patients with a known dihyropyrimidine dehydrogenase (DPD) deficiency. • Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded. • Patients with known brain metastases or leptomeningeal disease are excluded from this clinical trial • History of other malignancy. Subjects who have been disease-free for 5 years or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. • Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib or excipients of lapatinib • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to capecitabine, fluorouracil or any excipients • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. • Pregnant women are excluded from this study because lapatinib is member of the 4-anilinoquinazoline class of kinase inhibitors with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lapatinib, breastfeeding should be discontinued if the mother is treated with lapatinib. • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib. • Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn’s, ulcerative colitis). • Patients with concomitant requirement for medication classified as CYP3A4 inducers or inhibitors • Patients with active cardiac disease within the last six months, defined as: - Uncontrolled angina - Clinically significant arrhythmia, with the exception of asymptomatic atrial fibrillation requiring anticoagulation - Myocardial infarction < 6 months from study entry - Uncontrolled or symptomatic congestive heart failure - Ejection fraction below the institutional normal limit - Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Capecitabine in combination with Lapatinib, in terms of overall survival, in the first line treatment of patients with metastatic Pancreatic cancer. ;Secondary Objective: To evaluate: • Progression-free survival • Overall response rate (complete and partial responses) • Clinical benefit (complete response, partial response or stable disease for at least 6 months) • the qualitative and quantitative toxicity associated with Lapatinib administered with Capecitabine to patients with metastatic pancreatic cancer. • For patients where sufficient tumour samples are available for translational studies To characterize the patient population by determination of intra-tumoural expression of ErbB1 (EGFR) and ErbB2 (Her2/neu). ;Primary end point(s): The primary outcome measure is the overall survival (OS), measured as the number of weeks or fraction of a week between a patient’s enrolment and his or her date of death. Patients who are still living six months after the last patient has been enrolled will be censored for the analyses, using the number of days between enrolment and the date of their last follow-up as their overall survival measurement. | — |
Countries
Ireland
Outcome results
None listed