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Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer

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

NCT01303029•Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Ability to understand and willingness to sign a written informed consent
•2. Able, in the investigator's opinion, to fulfill the procedures and explorations of the study
•3. Age ≥ 18 years old
•4. ECOG 0-2
•5. Life expectancy ≥ 12 weeks
•6. Patients with metastatic adenocarcinoma of the pancreas, following 7th edition of TNM classification
•7. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the pancreas
•8. Measurable disease following RECIST criteria version 1.1
•9. 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
•10. Adequate bone marrow function as determined by:
+11 more criteria

Exclusion Criteria

•1. 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
•2. Pancreatic endocrine tumor and ampulloma
•3. 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.
•4. Primary tumors developed 5 years previous to the inclusion, except in situ cervix carcinoma or skin basocellular cancer properly treated
•5. 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)
+13 more criteria

Locations (1)

Spanish Cooperative Group for Digestive Tumour Therapy

Madrid, Spain

Key Dates

Start Date

February 1, 2011

Primary Completion Date

June 1, 2015

Completion Date

June 1, 2015

Last Updated

August 1, 2017

Enrollment

120

ACTUAL participants

Conditions

Metastatic Pancreatic Cancer

Interventions

Gemcitabine+erlotinib

DRUG

Gemcitabine+erlotinib+capecitabine

DRUG

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

NCT07409272

Pancreatic CancerMetastatic Pancreatic Cancer+1 more

View study

RECRUITINGPHASE2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

NCT05065801

Metastatic Pancreatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer