A Phase IIb Randomized Study to Evaluate the Efficacy of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)1 site in 1 country120 target enrollmentFebruary 2011

ConditionsMetastatic Pancreatic Cancer

InterventionsGemcitabine+erlotinib Gemcitabine+erlotinib+capecitabine

DrugsGemcitabine+erlotinib Gemcitabine+erlotinib+capecitabine

Overview

Phase: Phase 2
Intervention: Gemcitabine+erlotinib
Conditions: Metastatic Pancreatic Cancer
Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Enrollment: 120
Locations: 1
Primary Endpoint: Progression free survival
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the efficacy of the combination of gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in patients with metastatic pancreatic cancer.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

June 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to understand and willingness to sign a written informed consent
•Able, in the investigator's opinion, to fulfill the procedures and explorations of the study
•Age ≥ 18 years old
•Life expectancy ≥ 12 weeks
•Patients with metastatic adenocarcinoma of the pancreas, following 7th edition of TNM classification
•Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
•Measurable disease following RECIST criteria version 1.1
•No previous systemic treatment for metastatic pancreatic cancer Adjuvant chemotherapy al least 6 months before enrollment is allowed. Patients having neoadjuvant chemotherapy must have completed the treatment at least 4 weeks before trial entry. Toxicities associated to previous treatment must be resolved before enrollment. Progression disease (metastatic disease) must be confirmed after adjuvant treatment
•Adequate bone marrow function as determined by:
•Hemoglobin: ≥ 9 g/dL. (patients with hemoglobin \< 9 g/dL could be transfused before their inclusion on the study)

Exclusion Criteria

•Local pancreatic cancer (stage IA-IIB) or locally advance cancer (stage III), following the TNM 7th edition classification. Patients with metastatic disease that relapse after the initial diagnosis of local or advance disease could be included in this study
•Pancreatic endocrine tumor and ampulloma
•Evidence of carcinomatosis meningitis or brain metastasis. In case of clinical suspicious of brain metastasis is mandatory to perform a brain TAC/MR 4 weeks prior de inclusion.
•Primary tumors developed 5 years previous to the inclusion, except in situ cervix carcinoma or skin basocellular cancer properly treated
•Cardiovascular disease clinically significant (active):
•Non-controlled arterial hypertension (Systolic pressure \> 150 mg Hg and/or diastolic pressure \> 100 mm Hg on repeated pressure measurements)
•Cerebrovascular accident/ictus (≤ 6 weeks prior to inclusion)
•Myocardial infarction (≤ 6 months prior to inclusion)
•Unstable angina
•Congestive cardiac insufficiency (grade II or superior following to New York Heart Association (NYHA)

Arms & Interventions

Control

Gemcitabine+erlotinib

Intervention: Gemcitabine+erlotinib

Experimental

Gemcitabine+erlotinib+capecitabine

Intervention: Gemcitabine+erlotinib+capecitabine

Outcomes

Primary Outcomes

Progression free survival

Time Frame: 4 years

Secondary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability(4 years)
Duration of response(4 years)
Overall survival(4 years)
Response rate (RR)(4 years)
Percentage of rash in patients treated with erlotinib and progression free survival and overall survival and treatment relationship(4 years)