PURO Panitumumab in Combination With Gemcitabine/Cisplatin in Advanced Urothelial Cancer

NCT01374789 | Terminated Phase 2 DMC

• 3 other identifiers: WiSP_AG482009-015119-42GMIHO-007/2008
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 20

Brief Summary

The primary objective of the study is to assess the efficacy of the combination consisting of gemcitabine/cisplatin and panitumumab in patients with urothelial carcinoma and wild-type HRAS (non-mutated status). The progression-free survival rate at 12 months will be compared to expectations derived from historical data, which are verified by a randomised control group without the antibody.

Conditions

Urinary Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Primary end point: Progression-free survival rate after 12 months.

  12 months

Secondary Outcomes (4)

• Determination of best response (CR, PR and SD) rates in accordance with the RECIST criteria

  up to 18 weeks

• Duration of response, progression-free and overall survival time

  2 years

• Documentation of adverse effects in accordance with the NCI CTC criteria

  up to 18 weeks

• Documentation of quality of life on the basis of the EORTC questionnaire

  up to 18 weeks

Study Arms (2)

Arm A (GemCis + Panitumumab)

EXPERIMENTAL

gemcitabine + cisplatin + panitumumab

Drug: GemCis + Panitumumab

Arm B (GemCis)

ACTIVE COMPARATOR

gemcitabine + cisplatin

Drug: GemCis

Interventions

GemCis + Panitumumab DRUG

Gemcitabine: 1250 mg/m², day 1 and 8, i.v., q3 Cisplatin: 70 mg/m², day 2, i.v., q3 Panitumumab 9 mg/kg/body weight, i.v., day 1,q3

Also known as: Vectibix (Panitumumab)

Arm A (GemCis + Panitumumab)

GemCis DRUG

Gemcitabine: 1250 mg/m², day 1 and 8, i.v., q3 Cisplatin: 70 mg/m², day 2, i.v., q3

Arm B (GemCis)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed, unresectable urothelial carcinoma of the bladder or the upper urinary tract
• Wild-type HRAS
• Male and female subjects \> 18 years of age
• General condition ECOG 0-1
• Life expectancy at least 12 weeks
• Women of child-bearing potential: negative pregnancy test and use of effective contraception(oral contraceptive, coil); men: use of adequate male contraception (condom) for up to 3 months after discontinuation of panitumumab therapy
• Locally advanced or metastatic disease (T3b,T4 and/or N+ and/or M+)
• At least one unidimensionally measurable lesion detectable in CT or MRI corresponding to the RECIST criteria
• Adequate haematological, hepatic, renal and metabolic function parameters:
• Leukocytes \> 3000/mm³, ANC ≥ 1500/mm³, platelets ≥ 100,000/mm³, hemoglobin \> 9 g/dl Creatinine clearance ≥ 50 ml/min and serum creatinine ≤ 1.5 x upper limit of normal Bilirubin ≤ 1.5 x upper limit of normal, GOT-GPT ≤ 2.5 x upper limit of normal in absence of liver metastases, or ≤ 5 x upper limit of normal in presence of liver metastases, AP ≤ 5 x upper limit of normal Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal INR and PTT \< 1.5 x the upper limit of the normal reference range

You may not qualify if:

• HRAS mutation
• Dialysis-dependence following nephrectomy
• Patients with cerebral tumours and/or cerebral metastases
• Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.
• Patients with uncontrolled hypertension; systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg despite optimal medical treatment
• History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
• Patients with thrombotic or embolic events, such as stroke or pulmonary embolism
• Patients with recent or known history of haemorrhagic diathesis
• Known significant neurological or psychiatric disorders, including dementia and epileptic seizures
• Serious inflammatory eye conditions, hearing impairment
• Pulmonary (pO2 \< 60 mmHg), haemopoietic (e.g. serious bone marrow aplasia), hepatic or renal disorders
• Patients with poorly controlled diabetes mellitus
• Serious bacterial or fungal infections (\>grade 2 NCI CTC Version 3)
• Chronic hepatitis B or C; HIV infection
• Autoimmune disease

Sponsors & Collaborators

• WiSP Wissenschaftlicher Service Pharma GmbH: lead
• Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH: collaborator

Study Sites (20)

Bundeswehrkrankenhaus Berlin

Berlin, 10115, Germany

Location

Krankenhaus am Urban

Berlin, 10967, Germany

Location

Heilig-Geist-Krankenhaus

Cologne, 50737, Germany

Location

St.-Josefs-Hospitals Dortmund

Dortmund, 44263, Germany

Location

Universitätsklinikum Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Klinikum Fulda

Fulda, 36043, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover, Urologie

Hanover, 30625, Germany

Location

Universitätskllinikum Heidelberg

Heidelberg, 69121, Germany

Location

Klinikum Kassel

Kassel, 34215, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, 67063, Germany

Location

Universitätsklinikum Mainz

Mainz, 55131, Germany

Location

Uroloische Praxis

Markkleeberg, 04416, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Johanniter Krankenhaus

Stendal, 39576, Germany

Location

Universitätsklinikum Ulm, Urologische Klinik

Ulm, 89075, Germany

Location

Klinikum Weiden

Weiden, 92637, Germany

Location

Gemeinschaftspraxis für Urologie DGU

Wuppertal, 742103, Germany

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kurt Miller, Prof. Dr.

  Universitätsmedizin Charité Berlin, Klinik für Urologie

  PRINCIPAL INVESTIGATOR

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 30, 2011
• First Posted: June 16, 2011
• Study Start: July 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

DE (20)