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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Cisplatin
Capecitabine
Epirubicin
Cisplatin
Capecitabine
Oxaliplatin
Docetaxel
Capecitabine
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cisplatin / Capecitabine

Epirubicin / Cisplatin / Capecitabine

Epirubicin / Oxaliplatin / Capecitabine

Docetaxel / Cisplatin / Capecitabine

Arm Description

Cisplatin, 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.

Epirubicin, 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.

Epirubicin, 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.

Docetaxel, 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 30, 2007
Last Updated
August 23, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00454636
Brief Title
A Study of Xeloda (Capecitabine) in Combination With Chemotherapy in Patients With Advanced and/or Metastatic Gastric Cancer.
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cisplatin / Capecitabine
Arm Type
Experimental
Arm Description
Cisplatin, 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.
Arm Title
Epirubicin / Cisplatin / Capecitabine
Arm Type
Experimental
Arm Description
Epirubicin, 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.
Arm Title
Epirubicin / Oxaliplatin / Capecitabine
Arm Type
Experimental
Arm Description
Epirubicin, 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.
Arm Title
Docetaxel / Cisplatin / Capecitabine
Arm Type
Experimental
Arm Description
Docetaxel, 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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
80 mg/m2/day, intravenous (IV), every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
50 mg/m2/day, IV, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
60 mg/m2/day, IV, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
625 mg/m2, oral, twice daily per 3-week cycle
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130 mg/m2/day, IV, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
60 mg/m2/day, IV, every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
825 mg/m2, oral, twice daily for 2 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)
Time Frame
Approximately 3.25 years
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
Approximately 3.25 years
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Approximately 3.25 years
Title
Overall Survival (OS)
Description
OS was defined as the time elapsing from the date of the start of treatment until death, or last known follow-up.
Time Frame
Approximately 3.25 years
Title
Duration of Response
Description
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.
Time Frame
Approximately 3.25 years
Title
Time to Response
Description
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.
Time Frame
Approximately 3.25 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients, >=18 years of age; advanced or metastatic gastric cancer; Eastern Cooperative Oncology Group (ECOG) <=2. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Alcoy
State/Province
Alicante
ZIP/Postal Code
03804
Country
Spain
City
Gijon
State/Province
Asturias
ZIP/Postal Code
33394
Country
Spain
City
Cádiz
State/Province
Cadiz
ZIP/Postal Code
11009
Country
Spain
City
Jerez de La Frontera
State/Province
Cadiz
ZIP/Postal Code
11407
Country
Spain
City
Puerto Real
State/Province
Cadiz
ZIP/Postal Code
11510
Country
Spain
City
San Sebastian
State/Province
Guipuzcoa
ZIP/Postal Code
20080
Country
Spain
City
Barbastro
State/Province
Huesca
ZIP/Postal Code
22300
Country
Spain
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
City
Ferrol
State/Province
La Coruña
ZIP/Postal Code
15405
Country
Spain
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
City
Logroño
State/Province
La Rioja
ZIP/Postal Code
26006
Country
Spain
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
City
Avila
ZIP/Postal Code
05071
Country
Spain
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Burgos
ZIP/Postal Code
09006
Country
Spain
City
Castellon
ZIP/Postal Code
12002
Country
Spain
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
City
Girona
ZIP/Postal Code
17007
Country
Spain
City
Granada
ZIP/Postal Code
18003
Country
Spain
City
Granada
ZIP/Postal Code
18014
Country
Spain
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
City
Huesca
ZIP/Postal Code
22004
Country
Spain
City
Jaen
ZIP/Postal Code
23007
Country
Spain
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
City
La Coruña
ZIP/Postal Code
15009
Country
Spain
City
Leon
ZIP/Postal Code
24071
Country
Spain
City
Lerida
ZIP/Postal Code
25198
Country
Spain
City
Lugo
ZIP/Postal Code
27004
Country
Spain
City
Madrid
ZIP/Postal Code
28033
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28050
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Madrid
ZIP/Postal Code
28223
Country
Spain
City
Madrid
ZIP/Postal Code
28935
Country
Spain
City
Murcia
ZIP/Postal Code
30008
Country
Spain
City
Navarra
ZIP/Postal Code
31008
Country
Spain
City
Orense
ZIP/Postal Code
32005
Country
Spain
City
Palencia
ZIP/Postal Code
34005
Country
Spain
City
Pontevedra
ZIP/Postal Code
36002
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Toledo
ZIP/Postal Code
45004
Country
Spain
City
Valencia
ZIP/Postal Code
41014
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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