Trial Outcomes & Findings for Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer (NCT NCT00354224)

Last Updated: 2018-07-16

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Every 6 weeks through study completion for up to about 18 weeks

Results posted on

2018-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Oxaliplatin + Capecitabine Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. capecitabine oxaliplatin
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oxaliplatin + Capecitabine n=10 Participants Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. capecitabine oxaliplatin
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 6 weeks through study completion for up to about 18 weeks

Population: this data was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the start of study treatment through study completion for up to about 18 weeks

Outcome measures

Outcome measures
Measure	Oxaliplatin + Capecitabine n=10 Participants Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. capecitabine oxaliplatin
Number of Adverse Events	4 Serious Adverse Events

SECONDARY outcome

Timeframe: Every 6 weeks through study completion for up to about 18 weeks

Population: data was not collected for this endpoint.

Outcome measures

Outcome data not reported

Adverse Events

Oxaliplatin + Capecitabine

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Oxaliplatin + Capecitabine n=10 participants at risk Patients will receive Oxaliplatin 85 mg/m2/d on day 1, given as a 2-hour infusion in 250 mL of dextrose 5% repeated every 2 weeks. Capecitabine will be administered orally at a dose of 850 mg/m2 twice a day. capecitabine oxaliplatin
Skin and subcutaneous tissue disorders cellulitis	10.0% 1/10 • Number of events 1 • From the start of study treatment through study completion for up to about 18 weeks data for non-serious adverse events was not collected.
General disorders draining abdominal scar	10.0% 1/10 • Number of events 1 • From the start of study treatment through study completion for up to about 18 weeks data for non-serious adverse events was not collected.
Cardiac disorders supraventricular tachycardia	10.0% 1/10 • Number of events 1 • From the start of study treatment through study completion for up to about 18 weeks data for non-serious adverse events was not collected.
Cardiac disorders angina	10.0% 1/10 • Number of events 1 • From the start of study treatment through study completion for up to about 18 weeks data for non-serious adverse events was not collected.

Other adverse events

Adverse event data not reported

Additional Information

Kate Anderton

Medical University of South Carolina

Phone: 843-792-2708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place