A Phase II study of lapatanib and capecitabine in the treatment of metastatic pancreatic cancer - metastatic pancreatic cancer trial
- Conditions
- Metastatic pancreatic cancerMedDRA version: 9.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastatic
- Registration Number
- EUCTR2008-006907-22-IE
- Lead Sponsor
- ICORG - the All-Ireland Cooperative Oncology Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 57
• 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 = 1
• Age > or = 18 years. Because no dosing or adverse event data are currently available on the use of lapatinib in patients <18 years of age, children are excluded from this study.
• Life expectancy of greater than 12 weeks.
• ECOG performance status 0-1
• Adequate hematologic, renal and hepatic function measured within 14 days prior to commencing study treatment as defined below:
Body System and Adequate Function Definitions:
SYSTEM LABORATORY VALUES
Hematologic:
ANC (absolute neutrophil count) > 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 < or = 1.5 x ULN (< or = 2.5 x ULN if patient has Gilbert’s syndrome)
AST and ALT < or = 3 x ULN without liver metastases (< or =5 x ULN if documented liver metastases)
Renal
Serum Creatinine< 1.5 x ULN
• Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan. Note that baseline and on treatment scans should be performed using the same modality and preferably at the same institution.
• The effects of lapatinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.
• Able to swallow and retain oral medication
• Subjects must complete all screening assessments as outlined in the protocol
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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method