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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00454636

Enrollment

158

Registered

2007-04-02

Start date

2007-03-31

Completion date

2010-07-31

Last updated

2016-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

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.

Interventions

DRUGCisplatin

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

DRUGCapecitabine

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

DRUGEpirubicin

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

DRUGOxaliplatin

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

DRUGDocetaxel

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Overall Response Rate (ORR)	Approximately 3.25 years	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)	Approximately 3.25 years	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)	Approximately 3.25 years	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	Approximately 3.25 years	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	Approximately 3.25 years	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.

Countries

Spain

Participant flow

Participants by arm

Arm	Count
Cisplatin / Capecitabine Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 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	41
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	32
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	27
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.	58
Total	158

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	10	6	9	15
Overall Study	Death	6	1	1	1
Overall Study	Disease Progression	11	12	4	11
Overall Study	Lost to Follow-up	0	1	0	0
Overall Study	Patient refusal	1	1	3	2
Overall Study	Protocol Violation	3	2	3	3

Baseline characteristics

Characteristic	Cisplatin / Capecitabine	Epirubicin / Cisplatin / Capecitabine	Epirubicin / Oxaliplatin / Capecitabine	Docetaxel / Cisplatin / Capecitabine	Total
Age, Continuous	66 years	60 years	62 years	58 years	61 years
Sex: Female, Male Female	18 Participants	9 Participants	4 Participants	15 Participants	46 Participants
Sex: Female, Male Male	23 Participants	23 Participants	23 Participants	43 Participants	112 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	39 / 41	30 / 32	27 / 27	54 / 58
serious Total, serious adverse events	9 / 41	12 / 32	12 / 27	23 / 58