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Gastric CancerPhase 2NCT00454636

A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.

A Phase 2 study testing Cisplatin, Capecitabine and Epirubicin in people with Gastric Cancer, run by Hoffmann-La Roche at 51 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Cisplatin, Capecitabine and Epirubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
51 sitesSpain
Study dates
Mar 2007to Jul 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • adult patients, >=18 years of age;
  • advanced or metastatic gastric cancer;
  • Eastern Cooperative Oncology Group (ECOG) <=2.

Who cannot join

  • previous chemotherapy (except adjuvant or neoadjuvant treatment >=6 months prior to study);
  • evidence of central nervous system (CNS) metastasis;
  • history of another malignancy within the last 5 years (except for successfully treated basal cell cancer of skin, or in situ cancer of the cervix);
  • clinically significant cardiac disease.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

Spain51 sites

  • Study site

    A Coruña, La Coruña, 15006

  • Study site

    A Coruña, La Coruña, 15009

  • Study site

    Alcorcón, Madrid, 28922

  • Study site

    Alcoy, Alicante, 03804

  • Study site

    Ávila, Avila, 05071

  • Study site

    Barbastro, Huesca, 22300

  • Study site

    Barcelona, Barcelona, 08916

  • Study site

    Bilbao, Vizcaya, 48013

  • Study site

    Burgos, Burgos, 09006

  • Study site

    Cadiz, Cadiz, 11009

  • Study site

    Castellon, Castellon, 12002

  • Study site

    Córdoba, Cordoba, 14004

  • Study site

    Donostia / San Sebastian, Guipuzcoa, 20080

  • Study site

    Ferrol, La Coruña, 15405

  • Study site

    Gijón, Principality of Asturias, 33394

  • Study site

    Girona, Girona, 17007

  • Study site

    Granada, Granada, 18003

  • Study site

    Granada, Granada, 18014

  • Study site

    Guadalajara, Guadalajara, 19002

  • Study site

    Huesca, Huesca, 22004

  • Study site

    Jaén, Jaen, 23007

  • Study site

    Jerez de la Frontera, Cadiz, 11407

  • Study site

    León, Leon, 24071

  • Study site

    Lleida, Lerida, 25198

  • Study site

    Logroño, La Rioja, 26006

  • Study site

    Lugo, Lugo, 27004

  • Study site

    Madrid, Madrid, 28033

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Madrid, Madrid, 28050

  • Study site

    Madrid, Madrid, 28222

  • Study site

    Madrid, Madrid, 28223

  • Study site

    Madrid, Madrid, 28935

  • Study site

    Murcia, Murcia, 30008

  • Study site

    Navarra, Navarre, 31008

  • Study site

    Ourense, Orense, 32005

  • Study site

    Palencia, Palencia, 34005

  • Study site

    Palma de Mallorca, Balearic Islands, 07014

  • Study site

    Palma de Mallorca, Balearic Islands, 07198

  • Study site

    Pamplona, Navarre, 31008

  • Study site

    Pontevedra, Pontevedra, 36002

  • Study site

    Puerto Real, Cadiz, 11510

  • Study site

    Salamanca, Salamanca, 37007

  • Study site

    San Cristóbal de La Laguna, Tenerife, 38320

  • Study site

    Santiago de Compostela, La Coruña, 15706

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Toledo, Toledo, 45004

  • Study site

    Valencia, Valencia, 41014

  • Study site

    Valencia, Valencia, 46026

  • Study site

    Vigo, Pontevedra, 36312

  • Study site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

About this study

Official title: Open Label, Phase II Study of Capecitabine (Xeloda®) as Fluoropyrimidine of Choice in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer Suitable for Treatment With a Fluoropyrimidine-Based Regimen

This study will assess the safety and efficacy of Xeloda, given in combination with standard chemotherapy regimens, for the first-line treatment of advanced and/or metastatic gastric cancer. All patients will receive Xeloda in combination with one of 4 standard chemotherapy regimens; the dose of Xeloda will be from 625mg/m2 - 1000mg/m2 bid orally, depending on the chemotherapy regimen used. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Conditions
Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    80 mg/m2/day, intravenous (IV), every 3 weeks

  • CapecitabineDrug

    Also called Xeloda

    1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle

  • EpirubicinDrug

    50 mg/m2/day, IV, every 3 weeks

  • CisplatinDrug

    60 mg/m2/day, IV, every 3 weeks

  • CapecitabineDrug

    Also called Xeloda

    625 mg/m2, oral, twice daily per 3-week cycle

  • OxaliplatinDrug

    130 mg/m2/day, IV, every 3 weeks

  • DocetaxelDrug

    60 mg/m2/day, IV, every 3 weeks

  • CapecitabineDrug

    Also called Xeloda

    825 mg/m2, oral, twice daily for 2 weeks

Study groups in NCT00454636
Study groupRoleWhat they receive
Cisplatin / CapecitabineExperimentalCisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Receives: Drug: Cisplatin; Drug: Capecitabine
Epirubicin / Cisplatin / CapecitabineExperimentalEpirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
Receives: Drug: Epirubicin; Drug: Cisplatin; Drug: Capecitabine
Epirubicin / Oxaliplatin / CapecitabineExperimentalEpirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks.
Receives: Drug: Epirubicin; Drug: Capecitabine; Drug: Oxaliplatin
Docetaxel / Cisplatin / CapecitabineExperimentalDocetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
Receives: Drug: Cisplatin; Drug: Docetaxel; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)

    Measured: Approximately 3.25 years

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    ORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.

    Measured: Approximately 3.25 years

  2. Progression-Free Survival (PFS)

    PFS was defined as the time from the start of treatment to the first documentation of disease progression or death for any cause. Disease progression was based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria and was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Approximately 3.25 years

  3. Overall Survival (OS)

    OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up.

    Measured: Approximately 3.25 years

  4. Duration of Response

    Duration of Response was defined as the time of complete response (CR) or partial response (PR) until the first date of recurrent or progressive disease, based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference. Progressive disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

    Measured: Approximately 3.25 years

  5. Time to Response

    Time to Response was defined as the date of start of treatment until the first date of complete response (CR) or a partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 criteria. CR was defined as the disappearance of all target lesions; for non-target lesions, disappearance of lesions and normal tumor marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using the baseline sum LD as reference.

    Measured: Approximately 3.25 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00454636
Sponsor's protocol ID
ML20777
Status last verified
Aug 2016
First submitted
30 Mar 2007
Last updated
29 Sep 2016

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Capecitabine and Epirubicin in people with Gastric Cancer, run by Hoffmann-La Roche at 51 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 3 inclusion and 4 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 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 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?

Yes. Results are posted in the registry (first posted 19 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS) (time frame: Approximately 3.25 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00454636.

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 29 Sep 2016.

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