cholangiocarcinoma / gall bladder carcinoma MedDRA version: 15.0 Level: LLT Classification code 10017620 Term: Gallbladder carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 15.0 Level: LLT Classification code 10008593 Term: Cholangiocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Medizinische Hochschule Hannover (MHH)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed and dated informed consent before the start of specific protocol procedures. Histologically or cytologically documented diagnosis of cholangiocarcinoma or gall bladder carcinoma Presence of at least one measurable site of disease following RECIST V. 1.1 criteria Wild-type KRAS status as assessed by standardized PCR Unresectable, locally advanced or metastatic disease Age > 18 years. ECOG Performance Status of 0 or 1 Life expectancy of at least 12 weeks. Adequate bone marrow, liver (with stenting for any obstruction, if required) and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: -Hemoglobin > 10.0 g/dl -Leukocyte count >3.000/mm3 ; absolute neutrophil count (ANC) >1.500/mm3 -Platelet count >= 100.000/mm³ -Total bilirubin 60 ml/min. -Magnesium = lower limit of normal; calcium = lower limit of normal The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations. Negative pregnancy test performed within 7 days of the start of treatment, and willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 92 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 92
Exclusion criteria
Exclusion criteria: KRAS mutation Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrolment. History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. History of HIV infection or chronic hepatitis B Active clinically serious infections (> grade 2 NCI-CTC version 3.0) Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex Symptomatic or known brain metastases. A scan to confirm the absence of brain metastases is not required. Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) History of organ allograft Patients with evidence or history of bleeding diathesis Patients undergoing renal dialysis Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study Excluded therapies and medications, previous and concomitant: No prior anti-cancer chemotherapy, radiotherapy (excluding palliative radiotherapy administered more than 4 weeks prior to study entry), endocrine or immunotherapy. Investigational drug therapy outside of this trial during or within 4 weeks of study entry Major surgery within 4 weeks of starting the study and patients must have recovered from effects of major surgery Prior anti-EGFR therapy Autologous bone marrow transplant or stem cell rescue within 4 months of study Breast-feeding patients Substance abuse, medical, psychological or social conditions that may interfere with the patient’s understanding of the informed consent procedure, participation in the study or evaluation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of panitumumab plus the cisplatin/gemcitabine combination chemotherapy in k-ras wildtype in patients with cholangiocarcinoma / gallbladder carcinoma, compared to the historical data for the same chemotherapy, which are verified by a randomised control group without the antibody.;Secondary Objective: Response rate (RR) within 48 weeks of treatment, progression-free survival (PFS), overall survival (OS), safety: explorative evaluation in relation to the findings in the reference arm with respect to efficacy and toxicity, translational research: correlation of tumor response with KRAS, PTEn and B-Raf alterations.;Primary end point(s): The primary objective of the study is to determine the efficacy of panitumumab plus cisplatin/gemcitabine (CisGem) combination chemotherapy in KRAS wild-type biliary tract cancer patients without systemic pre-treatment, compared to the historical data for standard CisGem chemotherapy, which are verified by a randomised control group without the antibody. The primary endpoint is the progression-free survival rate after 6 months, based on the ITT population.;Timepoint(s) of evaluation of this end point: 6 months after trial inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints to be analyzed in both study arms (including exploratory comparisons) are: Tumor response according to RECIST criteria within the first 48 weeks of treatment Progression-free survival (PFS) Overall survival (OS) Toxicity/safety Translational: assessment/correlation of tumor response with KRAS (mandatory), EGFR, PTEN and BRAF (all 3 optional in the scope of the translational research) alterations in cholangiocarcinomas and gallbladder cancer. ;Timepoint(s) of evaluation of this end point: Tumor response within the first 48 weeks of treatment PFS, OS on event Toxicity/safety after end of therapy Translational correlation on response evaluation | — |
Countries
Germany
Contacts
Public ContactCRO
WiSP GmbH
Outcome results
None listed