EUCTR2008-003972-23-NLActive, not recruitingNot Applicable
Hepatocellular carcinoma: vascular abnormalities prior to, during and following systemic anti-cancer treatment - everolimus and capecitabine for HCC
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- MC
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Cytological or histological confirmed HCC who failed the standard therapies or who are not suitable for the standard therapies, i.e. metastectomy or liver transplantation.
- •- Age > 18 years.
- •- ECOG Performance Status of 0-2.
- •- Life expectancy of at least 12 weeks.
- •- Subjects with at least one uni-dimensional measurable lesion. Lesions must be measured by CT-scan or MRI.
- •- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •- Child-Pugh score of 7-9 points, i.e. Child-Pugh class B.
- •- Total bilirubin < 4 times the upper limit of normal.
- •- ALT and AST < 5 x upper limit of normal.
- •- INR < 2.2 x upper limit of normal (patients who are being therapeutically anticoagulated with coumarin derivatives will be allowed to participate provided that no evidence of prior abnormality in these parameters exists).
- •- Hemoglobin > 6 mmol/L.
- •- Absolute neutrophil count (ANC) >1,500/mm3.
- •- Platelet count ? 100,000/µl.
- •- Serum creatinine < 2 x upper limit of normal.
- •- Signed informed consent.
- •- Sexually active patients, in conjunction with their partner, must practice birth control during and for 2 months after therapy.
- •- Female patients at child-bearing age must have negative pregnancy test.
- •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
- •- History of cardiac disease: congestive heart failure >NYHA class 2; active coronary arterial disease (MI more than 6 mo prior to study entry is allowed); instable cardiac arrythmias; uncontrolled hypertension.
- •- History of HIV infection.
- •- Active clinically serious infections (> grade 2 NCI-CTC version 3.0) Hepatitis B carriers must be on lamivudine during and for 6 months after completion of study treatment.
- •- Symptomatic metastatic brain or meningeal tumors
- •- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
- •- Patients undergoing renal dialysis.
- •- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
- •- Anticancer chemotherapy, immunotherapy, hormonal therapy, or radiotherapy during the study or within 4 weeks of study entry. Major surgery within 4 weeks of start of study.
- •- Autologous bone marrow transplant or stem cell rescue within 4 months of study.
- •- Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted for a required dose reduction]. Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study or during the study.
- •- Investigational drug therapy outside of this trial during or within 4 weeks of study entry.
- •- Prior exposure to the study drug.
- •- Medical, psychological, or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
- •- Patients unstable to swallow oral medications.
Investigators
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