Phase II Study for the Evaluation of the Efficacy of Gemcitabine plus Erlotinib in Rash-positive Patients with metastatic pancreatic cancer and good risk factors

Phase 1

• Conditions: metastatic pancreatic carcinoma; MedDRA version: 18.1Level: LLTClassification code 10033576Term: Pancreas carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005471-17-DE
• Lead Sponsor: Klinikum der Universität München-Großhadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-03
• Last Update Posted: 12 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- Histologically (not cytologically) confirmed metastatic adenocarcinoma of the pancreas (UICC stadium IV; any T, any N, M1 following TNM)
- At least one measurable tumor lesion (CT or MRI) according to RECIST version 1.1
- ECOG PS 0 and 1
- between 18 and 75 years of age
- bilirubin = 1.5 ULN (biliary duct stent in absence of cholangitis is no contraindication)
- availability of tumor samples (no cytological samples)
- written informed consent in collection of tumor- and blood samples for translational research according to study protocol
- a minimum of 3 month life expectancy
- written informed consent
- a negative pregnancy test result within 7 days prior start of study treatment for women of childbearing potential
- sufficient renal-, liver- and bone marrow function.
-- ANC * 1,5 x 109/l
-- haemoglobin * 8 g/dl
-- thrombocytes * 100 x 109/l
-- serum creatinine * 1,25 x ULN
-- transaminases * 2,5 x ULN
(in case of liver metastases < 5-fach ULN)
-- creatinine clearance =30 ml/min
- legally competent study participant
- ability of regular continuous long-term follow up
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 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- resectable pancreatic carcinoma
- locally advanced pancreatic carcinoma (non-resectable tumor without distant metastases)
- prior palliative chemotherapy of the metastatic or locally advanced, non-resectable pancreatic carcinoma
- prior palliative radiotherapy of the metastatic or locally advanced, non-resectable pancreatic carcinoma
- radiotherapy within four weeks prior randomization or radiation of target lesions
- adjuvant chemo- or radiochemotherapy of the pancreatic carcinoma = six month prior randomisation
- any malignant metastatic disease and any curatively treated neoplasia diagnosed within the last five years prior randomisation
- major surgical intervention within the last two weeks prior randomisation
- chronic diarrhea
- known deficiency of glucuronidation (Gilbert-Meulengracht syndrome)
- acute or subacute ileus or inflammatory bowel disease
- pre-existing polyneuropathy > grade 1 regarding NCI-CTCAE v4.0
- severe concomitant disease that compromise eligibility and safety of the patient within the study, e.g. active infections or hepatic, renal or metabolic diseases
- clinically significant cardiovascular disease within the last twelve month prior randomisation (e.g. instable A. pectoris, myocardial infarction, cardiac insufficiency NYHA = II, arrhythmias requiring treatment)
- any psychological, familial, sociological or geographic condition that do not permit adherence to the study protocol
- untreated, symptomatic brain metastases (except the patient has undergone successful local therapy of the central brain metastases and no need for treatment with corticosteroids for at least four weeks prior randomisation. Radiological investigations to exclude brain metastases are mandatory only for symptomatic, but not for asymptomatic patients)
- known DPD deficiency
- concomitant therapy with the virostatics Sorivudin or its chemical relative Brivudin
- preganant or breast feeding women; non-effective contraception in men and pre-menopausal women (an effective method of contraception has a Pearl index of < 1)
- participation in another study within the last 28 days prior randomisation and during study participation
- hypersensitivity to any substance or other components used in this study
- former or ongoing keratitis or ulcerative keratitis or existence of severe dryness of the eyes

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1-year survival rate of good risk patients who develop Rash under treatment with gemcitabine/erlotinib;Secondary Objective: - evaluation of therapeutic efficacy parameter (ORR, DCR, PFS, OS) in Rash-positive and –negative patients<br>- tolerability<br>-- assessment according NCI-CTCAE v4.0<br>-- evaluation of the cutaneous side effects including weekly photodocumentation (within the first 4 weeks) and every 4 weeks during the following treatment<br>- translational project<br>-- evaluation of EGFR-associated singnal transduction parameters<br>-- evaluation of molecular biology parameters of skin toxicity<br>-- photodocumentation of erlotinib-associated skin toxicity, central evaluation and correlation with clinical and molecular biological parameters<br>;Primary end point(s): 1-year survival rate;Timepoint(s) of evaluation of this end point: weekly/biweekly during study treatment, every 3 month during follow up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): evaluation of therapeutic efficacy parameter (ORR, DCR, PFS, OS) in Rash-positive and –negative patients<br>;Timepoint(s) of evaluation of this end point: every 8 weeks during study treatment, every 3 month during follow up