Gemcitabine Plus Erlotinib in RASH-positive Patients With Metastatic Pancreatic Cancer

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In the current study it is examined whether patients with good risk factors (age <75 years, total serum bilirubin < 1,5xULN, no history of cardiovascular diseases) treated with gemcitabine and erlotinib who developed skin rash of any grade during the first 4 weeks of treatment have a comparable outcome as patients who receive FOLFIRINOX.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig-Maximilians - University of Munich
• Collaborator: Roche Pharma AG
• Treatments: Erlotinib Hydrochloride; Folic Acid; Gemcitabine; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically (not cytologically) confirmed metastatic pancreatic adenocarcinoma (stage IV according to UICC, each T, each N, M1 according to TNM)

• At least one measurable index lesion (CT or MRI) according to RECIST criteria (V 1.1)

• ECOG PS 0 and 1

• Age 18-75 years

• Serum bilirubin ≤1,5x ULN (a placed biliary tract stent without concurrent cholangitis is not considered a contraindication)

• Availability of tumour samples (no cytologic samples)

• Written informed consent by the patient for collecting blood- and tumour-samples for translational research according to study protocol

• Live expectancy of at least three months

• Written informed consent

• Negative pregnancy test in women with childbearing potential (to be performed within 7 days prior to treatment start)

• Adequate kidney-, liver- and bone-marrow function: neutrophils >= 1500/µl, platelets >= 100.000/µ, and hemoglobin >= 8g/dl, liver transaminases<= 2,5x ULN, in case of liver metastases <= 5x ULN, serum creatinine <= 1,25x ULN, creatinine clearance ≥ 30 ml/min

• Legal capacity of the patient

• Option for constant long-term follow-up

Exclusion Criteria:

• Resectable pancreatic carcinoma

• Locally advanced pancreatic cancer (non-resectable tumour without distant metastasis)

• Previous palliative chemotherapy for metastatic or locally advanced, non-resectable pancreatic cancer

• Previous palliative radiation or chemoradiation for locally advanced, non-resectable pancreatic cancer

• Radiation therapy within four weeks prior to study enrolment or radiation of indicator lesions

• Adjuvant Chemotherapy or Radiochemotherapy for pancreatic cancer ≤ 6 months prior to study ernrolment

• All previously occurred metastatic cancers or cured neoplasias diagnosed within the last 5 years before study enrolment

• Major surgery within 2 weeks before study start

• Chronic diarrhea

• Known glucuronidation-deficiency (Gilbert´s syndrome)

• Acute or subacute ileus or chronic inflammatory bowel disease

• Preexisting polyneuropathy > Grade I according to NCI-CTCAE v.4.0

• Relevant comorbidities which might impair patient eligibility or safety for study participation like active infections, hepatic, renal or metabolic diseases

• Clinically significant cardiovascular diseases within 12 months prior to study start (e.g. unstable angina pectoris, myocardial infarction, heart failure ≥ NYHA II, cardiac arrhythmias requiring treatment)