CONKO-005:Adjuvant Therapy in R0-resected Pancreatic Cancer Patients with Gemcitabine plus Erlotinib vs. Gemcitabine over 24 Weeks - a Prospective, Randomized Phase III Study

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00000247
• Date of registration: 04/03/2010
• Prospective Registration: No
• Primary sponsor: Charité-Universitätsmedizin Berlin
• Public title: CONKO-005:Adjuvant Therapy in R0-resected Pancreatic Cancer Patients with Gemcitabine plus Erlotinib vs. Gemcitabine over 24 Weeks - a Prospective, Randomized Phase III Study
• Scientific title: CONKO-005:Adjuvant Therapy in R0-resected Pancreatic Cancer Patients with Gemcitabine plus Erlotinib vs. Gemcitabine over 24 Weeks - a Prospective, Randomized Phase III Study - CONKO-005
• Date of first enrolment: 15/04/2008
• Target sample size: 450
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00000247
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: 3

Countries of recruitment

Germany

Contacts

• Name: Marianne Sinn
• Affiliation: Charité - Universitätsmedizin Berlin CharitéCentrum für Tumormedizin Medizinische Klinik mit Schwerpunkt Hämatologie/ Onkologie

• Name: Marianne Sinn
• Affiliation: Studiensekretariat Charité - Universitätsmedizin Berlin CharitéCentrum für Tumormedizin Medizinische Klinik m. S. Hämatologie und Onkologie

Key inclusion & exclusion criteria

Inclusion criteria: Histological confirmed diagnosis of an adenocarcinoma of the pancreas, Standardised surgery for tumor resection, e. g. partial pancreatoduodenectomy (Kausch-Whipple), pylorus-sparing partial pancreatoduodenectomy (PPPD), pancreas leftresection.
Result of resection: R0, No previous neoadjuvant therapy (chemotherapy or radiation), Performance-Status according to Karnofsky-Scale > 60 %, Patient compliance and geographical situation allowing an adequate follow up, especially the willingness to visit the same center regulary for at least 2 years after surgery, Sufficient bone marrow capacity: WBC > 3.5 × 109 /l, platelets
> 100 x 109/l, haemoglobin > 8 g/dl, Written informed consent of the patient prioral any precedure in connection with the study, Male and female patients with an age of at least 18 years, Initiation of the adjuvant therapy as soon as possible postoperative.
Soonest 2 weeks after resection but not before completion of
the wound healing at latest in between 8 weeks after resection.
Exclusion criteria: Seriouses systemic disease (with life expectance < 6 months) according to estimation of the investigator, active infection > Grad 2 NCI-CTCAE v3.0, Known HIV infection, Serious systemic disease: Uncontrolled hypertension, ingestive heart failure NYHA III - IV, symptomatic coronary heart disease, uncontrolled
cardial arrhythmia > grade II, peripher arterial disease > stage IIb, International Normalized Ratio (INR) > 1.5, prolongation of the activated partial prothrombin time (aPTT) > 1.5 x UNL (upper normal limit),
transaminases > 3x UNL, Postoperative measurable tumorlesion, Pregnant or breast-feeding women. Women of child-bearing potential must have an negative pregnancy test performed 7 days prior to start
of the treatment, Sexually active males or females with child-bearing potential unwilling to practice sufficient contraception during the study and for 3 months
after end of the study medication., Known allergical reactions against the study drugs or the substances included therein, Patients undergoing dialysis, Interstitial pneumonia or symptomatic fibrosis of the lung, Need of immunosuppressive therapy (e. g. transplantation), Severe non-healing wounds, ulcers or bone fracturs, Participation in another experimental clinical trial within 4 weeks prior to entry into the study, 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 stomac ulcer, Other primary malignancy in the patient's history (except for successfully treated basalioma or carcinoma in situ of the cervix uteri)

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

C25

Malignant neoplasm of pancreas

Intervention(s)

Group 1: Arm A:
Erlotinib 100 mg p.o. daily plus Gemcitabin 1000 mg/m² i.v. day 1, 8, 15. repetition day 29
Duration: 6 cycles (24 weeks)
Group 2: Arm B:
Gemcitabin 1000 mg/m² i.v. day 1, 8, 15. repetition day 29

Primary Outcome(s)

Relaps-free survival (RFS)

Secondary Outcome(s)

Overall survival, Toxicity

Secondary ID(s)

2007-003813-15

4033532

U1111-1114-0833

Source(s) of Monetary Support

Roche Pharma

Ethics review

Status: Approved
Approval date: 17/12/2007
Contact:

[e-mail]

Ethik-Kommission des Landes Berlin

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00000247#studyResults