Trial to Evaluate the Efficacy and Safety of Tarceva and Capecitabine in Advanced Pancreatic Cancer Patients (XELTA)

August 17, 2010 updated by: Grupo Gallego de Investigaciones Oncologicas

An Open Non-randomized Multicenter Phase II Trial to Evaluate the Efficacy and Safety of Tarceva in Combination With Capecitabine in Patients With Advanced Pancreatic Cancer

The purpose of this study is to determine efficacy of the treatment with erlotinib in combination with capecitabine in patients with advanced pancreatic cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This efficacy will be determined by objective response rate following RECIST criteria.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • La Coruña, Spain, 15009
        • Centro Oncologico de Galicia
      • La Coruña, Spain, 15006
        • Complejo Hospitalario Universitario de La Coruña
      • Lugo, Spain, 27004
        • Complejo Hospitalario Xeral Calde
      • Orense, Spain, 32005
        • Complejo Hospitalario de Orense
      • Vigo, Spain, 36200
        • Hospital Do Meixoeiro
      • Vigo, Spain, 36204
        • Complejo Hospitalario Xeral Cies
      • Vigo, Spain, 36211
        • Hospital Povisa
    • La Coruña
      • Ferrol, La Coruña, Spain, 15405
        • Hospital Arquitecto Marcide

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ability to understand and willingness to sign a written informed consent
  2. Informed consent signed by the patient
  3. Age > 18 years old
  4. Able to fulfill all criteria from the protocol
  5. Performance status Karnofsky ≥ 60% (ECOG 0-2)
  6. Life expectancy ≥ 12 weeks
  7. Histologically or cytological (excluding endocrine pancreatic tumour), with metastatic (stage IV), following 6th edition of TNM classification
  8. Measurable disease following RECIST criteria

  9. Adequate bone marrow function as determined by:

    • Absolute Neutrophil account (ANC) ≥ 1,5 x 109/L
    • Platelets: ≥ 100 x 109/L
    • Hemoglobin: ≥ 9 g/dL.

  10. Adequate liver function, as determined by:

    • Serum bilirubin (total): ≤ 1,5 x LSN
    • AST, ALT ≤ 2,5 x LSN in patients without liver metastasis. In patients with liver metastasis ≤ 5 x LSN

  11. Adequate renal function, as determined by:

    • Clearance creatinine > 60.0 ml/min
  12. Men or women potentially fertile (including postmenopausal women amenorrheic at least 24 months before the study) should use adequate contraceptive methods (oral contraceptives, intrauterine disposal, barrier methods together with spermicide or surgery sterilization)

Exclusion Criteria:

  1. Local pancreatic cancer (stage IA-IIB) or locally advance cancer (stage III), following the TNM 6th edition classification. Patients with metastatic disease that relapse after the initial diagnosis of local or advance disease could be included in this study.
  2. Evidence of medullary compression, carcinomatosis meningitis or brain metastasis. In case of clinical suspicious of brain metastasis is mandatory to perform a brain TAC/MR 4 weeks prior inclusion.
  3. Previous systemic treatment for metastasis pancreas cancer. Adjuvant chemotherapy is permitted ≥ 4 weeks prior de inclusion. All toxicities from the adjuvant treatment must been solve before the inclusion and should be confirmed the diseases progression (metastatic disease) alter adjuvant treatment
  4. Primary tumours Developer 5 years previous to the inclusion, except in situ cérvix carcinoma or skin basocellular cancer properly treated

  5. Non-controlled hypertension or cardiovascular disease clinically significant (active):

    • Cerebrovascular accident/ictus (≤ 6 weeks prior to inclusion)
    • Heart attack (≤ 6 months prior to inclusion)
    • Instable angina
    • Congestive cardiac insufficiency (grade II or superior following to New York Heart Association (NYHA)
    • Severe cardiac arrhythmia that require medication
  6. Significant ophthalmology anomalies
  7. Deficit in dihydropyrimidine dehydrogenase (DPD)
  8. 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.
  9. Pregnancy women or in latency period. Negative pregnancy test needed 7 days prior to initiation drug study
  10. Actual or 30 days previous to study treatment with other investigational drug or participation in other trial
  11. Previous treatment with Capecitabine or EGFR inhibitor.
  12. Any other disease, metabolic disease
  13. Known hypersensibility to any study drug or any of their component, or to 5-fluorouracile

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Unique arm

6 cycles (3 weeks each one) of :

  • capecitabine 1000mg/m2, bid, oral. Days: 1-14 every three weeks
  • erlotinib (Tarceva®) 150mg/day, oral. Days: every days
Drug: capecitabine + erlotinib

6 cycles (3 weeks each one) of :

  • capecitabine 1000mg/m2, bid, oral. Days: 1-14 every three weeks
  • erlotinib (Tarceva®) 150mg/day, oral. Days: every days
Other Names:
  • capecitabine (Xeloda®)y erlotinib (Tarceva®)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Objective response rate following RECIST criteria
Time Frame: within study period
within study period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival
Time Frame: within study period
within study period
6 months survival rate
Time Frame: within first 6 months after study inclusion
within first 6 months after study inclusion
Progression Free Survival (PFS)
Time Frame: Time from study inclusion to disease progression
Time from study inclusion to disease progression
Time to treatment failure (TTF)
Time Frame: Time from study inclusion to treatment failure
Time from study inclusion to treatment failure
To determine the index of clinical benefit
Time Frame: at the end of the study
at the end of the study
To determine the safety and tolerability of erlotinib and capecitabine when administered together
Time Frame: Within study period
Within study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grupo Gallego de Investigaciones Oncologicas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Rafel López López, Coordinator, Grupo Gallego de Investigaciones Oncológicas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML21154
  • 2007-003206-96 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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