NCT01303029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

4.3 years

First QC Date

February 16, 2011

Last Update Submit

July 31, 2017

Conditions

Metastatic Pancreatic Cancer

Keywords

Pancreatic cancergemcitabineerlotinibcapecitabine

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    4 years

Secondary Outcomes (5)

  • Overall survival

    4 years

  • Response rate (RR)

    4 years

  • Duration of response

    4 years

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    4 years

  • Percentage of rash in patients treated with erlotinib and progression free survival and overall survival and treatment relationship

    4 years

Study Arms (2)

Control

ACTIVE COMPARATOR

Gemcitabine+erlotinib

Drug: Gemcitabine+erlotinib

Experimental

EXPERIMENTAL

Gemcitabine+erlotinib+capecitabine

Drug: Gemcitabine+erlotinib+capecitabine

Interventions

Gemcitabine+erlotinibDRUG

Gemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks .

Control
Gemcitabine+erlotinib+capecitabineDRUG

Gemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Capecitabine will be administered orally 1.660 mg/m2 day from day 1 to day 21. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks .

Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • ECOG 0-2
  • 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:
  • Platelets: ≥ 100 x 109/L
  • Absolute Neutrophil account (ANC) ≥ 1,5 x 109/L
  • Adequate liver function, as determined by:
  • Serum bilirubin ≤ 1,5 x LSN
  • AST, ALT ≤ 2,5 x LSN in patients without liver metastasis. In patients with liver metastasis ≤ 5 x LSN
  • +5 more criteria

You may not qualify if:

  • 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
  • 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)
  • Unstable angina
  • Congestive cardiac insufficiency (grade II or superior following to New York Heart Association (NYHA)
  • Severe cardiac arrythmia requiring treatment
  • Significant ophthalmologic anomalies
  • Deficit in Dihydropyrimidine-Dehydrogenase (DPD)
  • Unable to take oral drug. Previous surgical process that affect the absorption or make the needed to have intravenous feeding or parenteral nutrition with lipids
  • Pregnancy women or in lactation period
  • Previous treatment with capecitabine or EGFR inhibitor
  • Metabolic disease or any other disease which, in the investigator's opinion, might interfere with the treatment in study
  • Known hypersensibility to any study drug (gemcitabine, erlotinib, capecitabine) or to 5-fluorouracile and fluoropyrimidines
  • Current infection grade ≥ 2 (CTCAE)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spanish Cooperative Group for Digestive Tumour Therapy

Madrid, 28046, Spain

Location

Related Publications (1)

  • Irigoyen A, Gallego J, Guillen Ponce C, Vera R, Iranzo V, Ales I, Arevalo S, Pisa A, Martin M, Salud A, Falco E, Saenz A, Manzano Mozo JL, Pulido G, Martinez Galan J, Pazo-Cid R, Rivera F, Garcia Garcia T, Serra O, Fernandez Parra EM, Hurtado A, Gomez Reina MJ, Lopez Gomez LJ, Martinez Ortega E, Benavides M, Aranda E; Spanish Cooperative Group of Treatment of Digestive Tumors (TTD). Gemcitabine-erlotinib versus gemcitabine-erlotinib-capecitabine in the first-line treatment of patients with metastatic pancreatic cancer: Efficacy and safety results of a phase IIb randomised study from the Spanish TTD Collaborative Group. Eur J Cancer. 2017 Apr;75:73-82. doi: 10.1016/j.ejca.2016.12.032. Epub 2017 Mar 7.

    PMID: 28222309DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Antonio Irigoyen, MD

    Hospital de Toledo, Spain

    STUDY CHAIR

  • Manuel Benavides, MD

    Hospital Carlos Haya, Málaga. Spain

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2011

First Posted

February 24, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

ES(1)