PiCCA Study (Panitumumab in Combination With Cisplatin/Gemcitabine)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Hannover Medical School
Sponsor:
Collaborator:
Hannover Clinical Trial Center GmbH
Information provided by (Responsible Party):
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT01320254
First received: March 21, 2011
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

The purpose of this 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 and to the randomised control group without the antibody, which verifies the historically based assumption.


Condition Intervention Phase
Cholangiocarcinomas
Drug: Cisplatin, Gemcitabine, Panitumumab
Drug: Cisplatin, Gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Panitumumab in Combination With Cisplatin/Gemcitabine Chemotherapy in Patients With Cholangiocarcinomas - a Randomized Clinical Phase II Study

Resource links provided by NLM:


Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • progression-free survival rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The progression-free survival rate at six months (primary endpoint) is defined as the number of patients recorded to be free of progression (according to RECIST) at this time point, divided by the number of patients randomized to the respective arm.


Secondary Outcome Measures:
  • Tumor response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Tumor response according to RECIST criteria within the first 48 weeks of treatment

  • Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) will be defined as the time from randomisation to the time of disease progression or relapse (according to RECIST) or death, or to the date of last assessment without any such event (censored observation).

  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The duration of overall survival (OS) will be determined by measuring the time interval from randomisastion to the date of death or last observation (censored).

  • Number of Participants with Adverse Events as a Measure of Toxicity/Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Translational research [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    assessment/ correlation of tumor response with KRAS (mandatory)

    alterations in cholangiocarcinomas and gallbladder cancer (EGFR, PTEN, BRAF)through optional translational research



Estimated Enrollment: 92
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin, Gemcitabine and Panitumumab
Experimental Arm with cisplatin 25mg/sq.m. at day 1 + 8, gemcitabine 1000mg/ sq.m.at day 1 + 8 and panitumumab 9mg/kg BW at day 1. Cycle will be repeated every 3 weeks.
Drug: Cisplatin, Gemcitabine, Panitumumab
Cisplatin 25mq/sq.m. at day 1+8 and Gemcitabine 1000mg/sq.m. at day 1 + 8 Panitumumab 9mg/kg BW at day 1
Other Names:
  • Vectibix (Panitumumab)
  • Gemzar (Gemcitabine)
  • Cisplatin 0.5mg/ml solution medac (Cisplatin)
Active Comparator: Cisplatin and Gemcitabine
Cisplatin 25mg/sq.m. at day 1 + 8 and Gemcitabine 1000 mg/sq.m. at day 1 + 8. Cycle will be repeated every 3 weeks.
Drug: Cisplatin, Gemcitabine
Cisplatin 25mq/sq.m. at day 1+8 and Gemcitabine 1000mg/sq.m. at day 1 + 8
Other Names:
  • Gemzar (Gemcitabine)
  • Cisplatin 0.5mg/ml solution medac (Cisplatin)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed,dated informed consent before start of specific protocol procedures
  • Histologically/cytologically documented diagnosis of cholangiocarcinoma or gall bladder carcinoma
  • 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 old
  • ECOG Performance Status 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, liver (with stenting for any obstruction, if required) and renal function (lab. assessment 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 prior to 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)

Exclusion Criteria:

  • KRAS mutation
  • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
  • 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 (patellar 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
  • 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 4weeks 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320254

Contacts
Contact: Arndt Vogel, PD Dr. MD +49 511 532 6766 vogel.arndt@mh-hannover.de

Locations
Germany
Esslingen Hospital Recruiting
Esslingen, Baden-Wuerttemberg, Germany, 73730
University Hospital Freiburg Not yet recruiting
Freiburg, Baden-Wuerttemberg, Germany, 79106
National Centre for Tumor Diseases (NCT) Recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69120
University Hospital Mannheim Recruiting
Mannheim, Baden-Wuerttemberg, Germany, 68167
Kreiskliniken Reutlingen GmbH Recruiting
Reutlingen, Baden-Wuerttemberg, Germany, 72764
University Hospital Tuebingen Recruiting
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Klinikum rechts der Isar der TU München Recruiting
München, Bavaria, Germany, 81675
University Hospital Regensburg Recruiting
Regensburg, Bavaria, Germany, 93042
Charité Berlin Recruiting
Berlin, Berlin-City, Germany, 13353
University Hospital Hamburg-Eppendorf Recruiting
Hamburg, Free City of Hamburg, Germany, 20246
University Hospital Marburg Recruiting
Marburg, Hesse, Germany, 35043
Medical School Hannover Recruiting
Hannover, Lower Saxony, Germany, 30625
University Hospital Essen Recruiting
Essen, Northrhine-Westfalia, Germany, 45122
University Hospital Köln Recruiting
Köln, Northrhine-Westfalia, Germany, 50924
University Hospital Mainz Recruiting
Mainz, Rhineland-Palatinate, Germany, 55131
Magdeburg Hospital Recruiting
Magdeburg, Saxony-Anhalt, Germany, 39130
Sponsors and Collaborators
Hannover Medical School
Hannover Clinical Trial Center GmbH
Investigators
Study Chair: Arndt Vogel, PD Dr. MD Hannover Medical School
  More Information

No publications provided

Responsible Party: Hannover Medical School, MD
ClinicalTrials.gov Identifier: NCT01320254     History of Changes
Other Study ID Numbers: EudraCT-Nr.: 2010-018850-11
Study First Received: March 21, 2011
Last Updated: October 10, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Hannover Medical School:
Palliative treatment
Panitumumab
Cisplatin
Cisplatinum
Gemcitabine
Vectibix

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Cisplatin
Antibodies, Monoclonal
Pharmaceutical Solutions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014