Trial Outcomes & Findings for Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (NCT NCT00443261)

Results Overview

Although response is not the primary endpoint of this trial, patients with measurable disease will by assessed by standard criteria. For the purpose of this study, patients should be re-evaluated every 8 weeks by imaging study. In addition to baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of an objective response.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

1 participants

Primary outcome timeframe

Weeks 1-12, 24, 36

Results posted on

2017-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: SCCHN Intervention: Azacitidine: SC daily X 5 every 28 days azacitidine at assigned dose ranging from 37 to 110 mg/M\^2/day. Cisplatin: cisplatin 75 mg/m\^2 day 8 every 28 days
Overall Study STARTED	1
Overall Study Accrual in 10 Months	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: SCCHN Intervention: Azacitidine: SC daily X 5 every 28 days azacitidine at assigned dose ranging from 37 to 110 mg/M\^2/day. Cisplatin: cisplatin 75 mg/m\^2 day 8 every 28 days
Overall Study Death	1

Baseline Characteristics

Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1: SCCHN n=1 Participants Azacitidine and cisplatin Azacitidine: SC azacitidine Cisplatin: cisplatin 75 mg/m2 day 8 every 28 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	52 Years STANDARD_DEVIATION 0 • n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 1-12, 24, 36

Population: The 1 patient enrolled in the study died after cycle 1 with rapidly progressing cancer. Therefore, no data to analyze for primary outcome measure.

Although response is not the primary endpoint of this trial, patients with measurable disease will by assessed by standard criteria. For the purpose of this study, patients should be re-evaluated every 8 weeks by imaging study. In addition to baseline scan, confirmatory scans will also be obtained 4 weeks following initial documentation of an objective response.

Outcome measures

Outcome measures
Measure	Arm 1: SCCHN Azacitidine and cisplatin Azacitidine: SC azacitidine Cisplatin: cisplatin 75 mg/m\^2 day 8 every 28 days
Evaluate the Safety and Toxicity of Azacitidine (5-azacytidine, Vidaza®) and Cisplatin Combination	0

Adverse Events

1: SCCHN

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	1: SCCHN n=1 participants at risk Azacitidine and cisplatin Azacitidine: SC azacitidine Cisplatin: cisplatin 75 mg/m2 day 8 every 28 days
Infections and infestations Pnemonia	100.0% 1/1 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stephen Williamson

University of Kansas Cancer Center

Phone: 9139455059

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place