Trial Outcomes & Findings for Phase II (Treatment) Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies (NCT NCT00266279)

Results Overview

Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Overall Response Rate (ORR)=PR+CR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Every two 28 day treatment cycles until subject no longer on treatment due to disease progression

Results posted on

2020-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment With Study Drugs Treatment with combination of oxaliplatin and capecitabine using study dose and schedule. Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle): Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II (Treatment) Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With Study Drugs n=15 Participants Treatment with combination of oxaliplatin and capecitabine using study dose and schedule. Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle): Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21
Age, Customized >=18 years	15 Participants n=5 Participants
Sex/Gender, Customized Male	10 Participants n=5 Participants
Sex/Gender, Customized Femal	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every two 28 day treatment cycles until subject no longer on treatment due to disease progression

Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Overall Response Rate (ORR)=PR+CR.

Outcome measures

Outcome measures
Measure	Treatment With Study Drugs n=15 Participants Treatment with combination of oxaliplatin and capecitabine using study dose and schedule. Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle): Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21
Overall Response Rate Partial Response	2 Participants
Overall Response Rate Stable Disease	5 Participants

SECONDARY outcome

Timeframe: At study enrollment, Every two 28 day treatment cycles, and at end of treatment due to disease progression

Number of patients that developed common side effect of diarrhea.

Outcome measures

Outcome measures
Measure	Treatment With Study Drugs n=15 Participants Treatment with combination of oxaliplatin and capecitabine using study dose and schedule. Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle): Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21
Qualitative and Quantitative Toxicity	2 participants

Adverse Events

Treatment With Study Drugs

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment With Study Drugs n=15 participants at risk Treatment with combination of oxaliplatin and capecitabine using study dose and schedule. Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle): Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21
Infections and infestations Pneumonia	13.3% 2/15 • Number of events 2
General disorders Dehydration	6.7% 1/15 • Number of events 1
Gastrointestinal disorders Gastrointestinal Bleeding	6.7% 1/15 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

University of Louisville, James Graham Brown Cancer Center Clinical Trials

University of Louisville, James Graham Brown Cancer Center

Phone: 502-562-3429

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place