CONKO-005: Adjuvante Therapie des R0-resezierten Pankreaskarzinoms mit Gemcitabin plus Erlotinib versus Gemcitabin über 24 Wochen – eine prospektive, randomisierte, Phase III Studie - CONKO-005

• Register: EUCTR
• Last refreshed on: 28 November 2016
• Main ID: EUCTR2007-003813-15-DE
• Date of registration: 26/10/2007
• Prospective Registration: Yes
• Primary sponsor: Charité - Universitätsmedizin Berlin
• Public title: CONKO-005: Adjuvante Therapie des R0-resezierten Pankreaskarzinoms mit Gemcitabin plus Erlotinib versus Gemcitabin über 24 Wochen – eine prospektive, randomisierte, Phase III Studie - CONKO-005
• Scientific title: CONKO-005: Adjuvante Therapie des R0-resezierten Pankreaskarzinoms mit Gemcitabin plus Erlotinib versus Gemcitabin über 24 Wochen – eine prospektive, randomisierte, Phase III Studie - CONKO-005
• Date of first enrolment: 26/11/2007
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003813-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Erlotinib vs. no Erlotinib
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
R0-resection
histologically confirmed diagnosis of an adenocarcinoma of the pancreas
no previous neoadjuvant anticancer treatment
karnofsky performance status > = 60%
patient compliance
signed informed consent
sufficient blood cell count
age > = 18 years
beginning of the chemotherapy between week 2-8 post OP, wound healing must be completed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Other serious illness: uncontrolled hypertension, congestive heart failure (NYHA III-IV), symptomatically coronary heart disease, uncontrolled cardial arrythmia > grade 2, occlusive periphere arterial disease > stage IIb
other serious illness with life expectancy < 6 month
active infection > grade 2 NCI-CTCAE v3.0
impaired renal or liver function
postoperative mesurable tumorlesion
pregnant or braestfeeding patients. Woman of childbearing potential must have a negative pregnancy test performewd 7 days prior to start of the traetment
sexually active males and females with child-bearing potential unwilling to practice sufficient contraception during the study and for 3 month after end of study medication
known allergic reactions against the study drugs or the substances included therein
patients undergoing renal dialysis
interstitial pneumonia or symptomatic fibrosis of the lung
immuno-suppressive therapy (e.g. allogeneic transplantation)
severe non-healing wounds, ulcers or bone fractions
enrollment in another clinical trial
previous or ongoing narcotic drug, medication or alcohol abuse
patients which are not able to take in oral drugs, need parenteral nutrition, are known to have an insufficient gastrointestinal resorption or suffer from acute stomach ulcer
other primary malignancy in the patient's history (except for successfully treated basalioma or carcinoma in situ of the cervix uteri)





Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

pancreatic cancer adjuvant therapy after R0-resection Gemcitabine plus Erlotinib vs. Gemcitabine mono, given over 24 weeks randomised trial

Intervention(s)

Trade Name: Tarceva
Product Name: Erlotinib
Product Code: n/a L01XX34
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Erlotinib
Other descriptive name: Tarceva
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Tarceva
Product Name: Erlotinib
Product Code: n/a L01XX34
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Erlotinib
Other descriptive name: Tarceva
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Gemcitabine hydrochloride
CAS Number: 122111039
Other descriptive name: Gemzar

Primary Outcome(s)

Primary end point(s): to compare diseasde free survival in both treatment groups
relapse of the pancreatic cancer

Secondary Objective: to compare the overall survival in both treatment groups,
toxicity

Main Objective: to compare the disease free survival in both treatment groups

Secondary ID(s)

CONKO-005