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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Drug: Cisplatin; Drug: Capecitabine; Drug: Cisplatin; Drug: Capecitabine; Drug: Capecitabine; Drug: Epirubicin; Drug: Oxaliplatin; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Avila, Spain, 05071
  • Barcelona, Spain, 08916
  • Burgos, Spain, 09006
  • Castellon, Spain, 12002
  • Cordoba, Spain, 14004
  • Girona, Spain, 17007
  • Granada, Spain, 18014
  • Granada, Spain, 18003
  • Guadalajara, Spain, 19002
  • Huesca, Spain, 22004
  • Jaen, Spain, 23007
  • La Coruña, Spain, 15006
  • La Coruña, Spain, 15009
  • Leon, Spain, 24071
  • Lerida, Spain, 25198
  • Lugo, Spain, 27004
  • Madrid, Spain, 28034
  • Madrid, Spain, 28041
  • Madrid, Spain, 28222
  • Madrid, Spain, 28033
  • Madrid, Spain, 28223
  • Madrid, Spain, 28050
  • Madrid, Spain, 28935
  • Murcia, Spain, 30008
  • Navarra, Spain, 31008
  • Orense, Spain, 32005
  • Palencia, Spain, 34005
  • Pontevedra, Spain, 36002
  • Salamanca, Spain, 37007
  • Sevilla, Spain, 41013
  • Toledo, Spain, 45004
  • Valencia, Spain, 46026
  • Valencia, Spain, 41014
  • Zaragoza, Spain, 50009
  • Alicante
    • Alcoy, Alicante, Spain, 03804
  • Asturias
    • Gijon, Asturias, Spain, 33394
  • Cadiz
    • Cádiz, Cadiz, Spain, 11009
    • Jerez de La Frontera, Cadiz, Spain, 11407
    • Puerto Real, Cadiz, Spain, 11510
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20080
  • Huesca
    • Barbastro, Huesca, Spain, 22300
  • Islas Baleares
    • Palma De Mallorca, Islas Baleares, Spain, 07014
    • Palma de Mallorca, Islas Baleares, Spain, 07198
  • La Coruña
    • Ferrol, La Coruña, Spain, 15405
    • Santiago de Compostela, La Coruña, Spain, 15706
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
  • Navarra
    • Pamplona, Navarra, Spain, 31008
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cisplatin / Capecitabine; 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.	Drug: Cisplatin; 80 mg/m2/day, intravenous (IV), every 3 weeks; Drug: Capecitabine; 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle; Other Names: Xeloda; Drug: Cisplatin; 60 mg/m2/day, IV, every 3 weeks; Drug: Capecitabine; 625 mg/m2, oral, twice daily per 3-week cycle; Other Names: Xeloda; Drug: Capecitabine; 825 mg/m2, oral, twice daily for 2 weeks; Other Names: Xeloda
Experimental: Epirubicin / Cisplatin / Capecitabine; 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.	Drug: Cisplatin; 80 mg/m2/day, intravenous (IV), every 3 weeks; Drug: Capecitabine; 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle; Other Names: Xeloda; Drug: Cisplatin; 60 mg/m2/day, IV, every 3 weeks; Drug: Capecitabine; 625 mg/m2, oral, twice daily per 3-week cycle; Other Names: Xeloda; Drug: Capecitabine; 825 mg/m2, oral, twice daily for 2 weeks; Other Names: Xeloda; Drug: Epirubicin; 50 mg/m2/day, IV, every 3 weeks
Experimental: Epirubicin / Oxaliplatin / Capecitabine; 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.	Drug: Capecitabine; 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle; Other Names: Xeloda; Drug: Capecitabine; 625 mg/m2, oral, twice daily per 3-week cycle; Other Names: Xeloda; Drug: Capecitabine; 825 mg/m2, oral, twice daily for 2 weeks; Other Names: Xeloda; Drug: Epirubicin; 50 mg/m2/day, IV, every 3 weeks; Drug: Oxaliplatin; 130 mg/m2/day, IV, every 3 weeks
Experimental: Docetaxel / Cisplatin / Capecitabine; 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.	Drug: Cisplatin; 80 mg/m2/day, intravenous (IV), every 3 weeks; Drug: Capecitabine; 1,000 mg/m2, oral, twice daily for 2 weeks, followed by 1 week of rest in each cycle; Other Names: Xeloda; Drug: Cisplatin; 60 mg/m2/day, IV, every 3 weeks; Drug: Capecitabine; 625 mg/m2, oral, twice daily per 3-week cycle; Other Names: Xeloda; Drug: Capecitabine; 825 mg/m2, oral, twice daily for 2 weeks; Other Names: Xeloda; Drug: Docetaxel; 60 mg/m2/day, IV, every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Grade 3 Hand-Foot Syndrome (HFS)	Approximately 3.25 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 3.25 years
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.	Approximately 3.25 years
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.	Approximately 3.25 years
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.	Approximately 3.25 years
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.	Approximately 3.25 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: March 30, 2007
• First Submitted That Met QC Criteria: March 30, 2007
• First Posted (Estimate): April 2, 2007

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Cisplatin; Capecitabine; Epirubicin; Oxaliplatin
• Other Study ID Numbers: ML20777