Metastatic Adenocarcinoma of the PancreasPhase 2XELTANCT00873353
Trial to Evaluate the Efficacy and Safety of Tarceva and Capecitabine in Advanced Pancreatic Cancer Patients
A Phase 2 study testing capecitabine + erlotinib in people with Metastatic Adenocarcinoma of the Pancreas, run by Grupo Gallego de Investigaciones Oncologicas at 8 sites in Spain.
Trial summary
The purpose of this study is to determine efficacy of the treatment with erlotinib in combination with capecitabine in patients with advanced pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Adenocarcinoma of the Pancreas
- What is being tested?
- capecitabine + erlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 8 sitesSpain
- Study dates
- Mar 2008to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign a written informed consent
- Informed consent signed by the patient
- Age > 18 years old
- Able to fulfill all criteria from the protocol
- Performance status Karnofsky ≥ 60% (ECOG 0-2)
- Life expectancy ≥ 12 weeks
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- Histologically or cytological (excluding endocrine pancreatic tumour), with metastatic (stage IV), following 6th edition of TNM classification
- Measurable disease following RECIST criteria
- 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.
- 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
- Adequate renal function, as determined by:
- Clearance creatinine > 60.0 ml/min
- 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)
Who cannot join
- 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.
- 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.
- 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
- Primary tumours Developer 5 years previous to the inclusion, except in situ cérvix carcinoma or skin basocellular cancer properly treated
- Non-controlled hypertension or cardiovascular disease clinically significant (active):
- Cerebrovascular accident/ictus (≤ 6 weeks prior to inclusion)
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- 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
- Significant ophthalmology 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 latency period. Negative pregnancy test needed 7 days prior to initiation drug study
- Actual or 30 days previous to study treatment with other investigational drug or participation in other trial
- Previous treatment with Capecitabine or EGFR inhibitor.
- Any other disease, metabolic disease
- Known hypersensibility to any study drug or any of their component, or to 5-fluorouracile
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Complejo Hospitalario Universitario de La Coruña
A Coruña, La Coruña, 15006
Centro Oncológico de Galicia
A Coruña, La Coruña, 15009
Hospital Arquitecto Marcide
Ferrol, La Coruña, 15405
Complejo Hospitalario Xeral Calde
Lugo, Lugo, 27004
Complejo Hospitalario de Orense
Ourense, Orense, 32005
Hospital do Meixoeiro
Vigo, Vigo, 36200
Complejo Hospitalario Xeral Cies
Vigo, Vigo, 36204
Hospital POVISA
Vigo, Vigo, 36211
About this study
Official title: 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.
Read the detailed description
This efficacy will be determined by objective response rate following RECIST criteria.
- Being tested
- capecitabine + erlotinib
- Keywords
- Metastatic Adenocarcinoma of the Pancreas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabine + erlotinibDrug
Also called capecitabine (Xeloda®)y erlotinib (Tarceva®)
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
| Study group | Role | What they receive |
|---|---|---|
| Unique arm | Experimental | 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 Receives: Drug: capecitabine + erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate following RECIST criteria
Measured: within study period
Secondary outcomes (6)
Overall survival
Measured: within study period
6 months survival rate
Measured: within first 6 months after study inclusion
Progression Free Survival (PFS)
Measured: Time from study inclusion to disease progression
Time to treatment failure (TTF)
Measured: Time from study inclusion to treatment failure
To determine the index of clinical benefit
Measured: at the end of the study
To determine the safety and tolerability of erlotinib and capecitabine when administered together
Measured: Within study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2009 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Gallego de Investigaciones Oncologicas
- Sponsor type
- University, hospital or other
- Investigators
- Rafel López López, Coordinator, Study chair, Grupo Gallego de Investigaciones Oncológicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873353
- Sponsor's protocol ID
- ML21154
- Other IDs
- 2007-003206-96
- Acronym
- XELTA
- Status last verified
- Aug 2010
- First submitted
- 31 Mar 2009
- Last updated
- 18 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00873353
- Acronym / sponsor ID
- XELTA / ML21154
- Keywords
- Metastatic Adenocarcinoma of the Pancreas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Grupo Gallego de Investigaciones OncologicasUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine efficacy of the treatment with erlotinib in combination with capecitabine in patients with advanced pancreatic cancer.
Detailed description
This efficacy will be determined by objective response rate following RECIST criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unique arm | Experimental | Drug: capecitabine + erlotinib6 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Ability to understand and willingness to sign a written informed consent
- Informed consent signed by the patient
- Age > 18 years old
- Able to fulfill all criteria from the protocol
- Performance status Karnofsky ≥ 60% (ECOG 0-2)
Key exclusion criteria (18 listed)
- 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.
- 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.
- 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
- Primary tumours Developer 5 years previous to the inclusion, except in situ cérvix carcinoma or skin basocellular cancer properly treated
- Non-controlled hypertension or cardiovascular disease clinically significant (active):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capecitabine + erlotinibAlso: capecitabine (Xeloda®)y erlotinib (Tarceva®)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 | Unique arm |
Primary outcome
Objective response rate following RECIST criteria
Time frame: within study period
6 secondary outcomes
Overall survival
Time frame: within study period
6 months survival rate
Time frame: within first 6 months after study inclusion
Progression Free Survival (PFS)
Time frame: Time from study inclusion to disease progression
Time to treatment failure (TTF)
Time frame: Time from study inclusion to treatment failure
To determine the index of clinical benefit
Time frame: at the end of the study
To determine the safety and tolerability of erlotinib and capecitabine when administered together
Time frame: Within study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafel López López, Coordinator study chair
Grupo Gallego de Investigaciones Oncológicas
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine + erlotinib in people with Metastatic Adenocarcinoma of the Pancreas, run by Grupo Gallego de Investigaciones Oncologicas at 8 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate following RECIST criteria (time frame: within study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2010.