PiCCA Study (Panitumumab in Combination With Cisplatin/Gemcitabine)

NCT01320254 | Completed Phase 2 DMC

• 1 other identifier: EudraCT-Nr.: 2010-018850-11
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Cholangiocarcinomas

Keywords

Palliative treatment; Panitumumab; Cisplatin; Cisplatinum; Gemcitabine; Vectibix

Outcome Measures

Primary Outcomes (1)

• progression-free survival rate

  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.

  6 months

Secondary Outcomes (5)

• Tumor response

  48 weeks

• Progression-free survival

  3 years

• Overall survival

  3 years

• Number of Participants with Adverse Events as a Measure of Toxicity/Safety

  3 years

• Translational research

  3 years

Study Arms (2)

Cisplatin, Gemcitabine and Panitumumab

EXPERIMENTAL

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 and Gemcitabine

ACTIVE COMPARATOR

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

Interventions

Cisplatin, Gemcitabine, Panitumumab DRUG

Cisplatin 25mq/sq.m. at day 1+8 and Gemcitabine 1000mg/sq.m. at day 1 + 8 Panitumumab 9mg/kg BW at day 1

Also known as: Vectibix (Panitumumab), Gemzar (Gemcitabine), Cisplatin 0.5mg/ml solution medac (Cisplatin)

Cisplatin, Gemcitabine and Panitumumab

Cisplatin, Gemcitabine DRUG

Cisplatin 25mq/sq.m. at day 1+8 and Gemcitabine 1000mg/sq.m. at day 1 + 8

Also known as: Gemzar (Gemcitabine), Cisplatin 0.5mg/ml solution medac (Cisplatin)

Cisplatin and Gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (16)

Esslingen Hospital

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

Location

University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

National Centre for Tumor Diseases (NCT)

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

University Hospital Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Kreiskliniken Reutlingen GmbH

Reutlingen, Baden-Wurttemberg, 72764, Germany

Location

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Klinikum rechts der Isar der TU München

München, Bavaria, 81675, Germany

Location

University Hospital Regensburg

Regensburg, Bavaria, 93042, Germany

Location

Charité Berlin

Berlin, Berlin-City, 13353, Germany

Location

University Hospital Hamburg-Eppendorf

Hamburg, Free City of Hamburg, 20246, Germany

Location

University Hospital Marburg

Marburg, Hesse, 35043, Germany

Location

Medical School Hannover

Hanover, Lower Saxony, 30625, Germany

Location

University Hospital Köln

Cologne, Northrhine-Westfalia, 50924, Germany

Location

University Hospital Essen

Essen, Northrhine-Westfalia, 45122, Germany

Location

University Hospital Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Magdeburg Hospital

Magdeburg, Saxony-Anhalt, 39130, Germany

Location

Related Publications (1)

• Vogel A, Kasper S, Bitzer M, Block A, Sinn M, Schulze-Bergkamen H, Moehler M, Pfarr N, Endris V, Goeppert B, Merx K, Schnoy E, Siveke JT, Michl P, Waldschmidt D, Kuhlmann J, Geissler M, Kahl C, Evenkamp R, Schmidt T, Kuhlmann A, Weichert W, Kubicka S. PICCA study: panitumumab in combination with cisplatin/gemcitabine chemotherapy in KRAS wild-type patients with biliary cancer-a randomised biomarker-driven clinical phase II AIO study. Eur J Cancer. 2018 Mar;92:11-19. doi: 10.1016/j.ejca.2017.12.028. Epub 2018 Feb 3.

  PMID: 29413685 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Cisplatin; Gemcitabine; Panitumumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Arndt Vogel, PD Dr. MD

  Hannover Medical School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: June 1, 2011
• Primary Completion: September 12, 2016
• Study Completion: September 12, 2016
• Last Updated: October 12, 2017

Record last verified: 2017-10

Locations

DE (16)