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

NCT01729481 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-07-19

No results posted yet for this study

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.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

Gemcitabine

1000 mg/m² iv weekly

DRUG

Erlotinib

100mg, once per day

DRUG

Oxaliplatin

85mg/m², q2weeks

DRUG

Folinic Acid

400 mg/m², q2weeks

DRUG

Irinotecan

180 mg/m², q2weeks

DRUG

5-FU

400 mg/m² Day 1; 2400 mg/m² 46 hour invusion, q2weeks

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Volker Heinemann, Professor · Medical Department III and Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-07-31
Completion
2017-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01729481 on ClinicalTrials.gov