Panitumumab in combination with cisplatin/gemcitabine chemotherapy in patients with bile duct cancer - a randomized clinical phase II study - PiCCA Study

• Conditions: cholangiocarcinoma / gall bladder carcinoma; MedDRA version: 15.0Level: LLTClassification code 10017620Term: Gallbladder carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 15.0Level: LLTClassification code 10008593Term: CholangiocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-018850-11-DE
• Lead Sponsor: Medizinische Hochschule Hannover (MHH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-22
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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 < 5,0 times the upper limit of normal
-ALT and AST < 3 x upper limit of normal
-Alkaline phosphatase < 5 x ULN
-PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.]
-Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified