Trial Outcomes & Findings for Weekly Oxaliplatin and Gemcitabine for Recurrent or Metastatic Head and Neck Cancer (NCT NCT00256295)

Last Updated: 2017-02-01

Results Overview

Complete Response (CR): Complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same techniques as baseline. Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

5 years

Results posted on

2017-02-01

Participant Flow

Study start date: April 2005 Primary completion date: February 2008 Study completion date: October 2011

Participant milestones

Participant milestones
Measure	Gemcitabine Plus Oxaliplatin Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days. Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days
Overall Study STARTED	7
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Gemcitabine Plus Oxaliplatin Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days. Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days
Overall Study Withdrawal by Subject	3
Overall Study Death	1

Baseline Characteristics

Weekly Oxaliplatin and Gemcitabine for Recurrent or Metastatic Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine Plus Oxaliplatin n=7 Participants Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days. Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=99 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants
Gender Female	1 Participants n=99 Participants
Gender Male	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	7 participants n=99 Participants

PRIMARY outcome

Timeframe: 5 years

Population: No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Population: No subject data were analyzed; therefore, data cannot be summarized for inclusion in these data tables.

Outcome measures

Outcome data not reported

Adverse Events

Gemcitabine Plus Oxaliplatin

Serious events: 6 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine Plus Oxaliplatin n=7 participants at risk Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days. Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days
General disorders Death due to disease progression	57.1% 4/7 • Number of events 4
Metabolism and nutrition disorders Dehydration due to disease progression	14.3% 1/7 • Number of events 1
Infections and infestations Pneumonia due to disease progression	14.3% 1/7 • Number of events 1
Vascular disorders Carotid artery rupture due to disease progression	14.3% 1/7 • Number of events 1
Hepatobiliary disorders Grade II Hepatic toxicity	14.3% 1/7 • Number of events 1
General disorders Broken leg due to fall	14.3% 1/7 • Number of events 1

Other adverse events

Other adverse events
Measure	Gemcitabine Plus Oxaliplatin n=7 participants at risk Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days. Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days
Cardiac disorders Grade 3 Sinus Tachycardia	14.3% 1/7 • Number of events 1

Additional Information

Nicole Macaranas

University of California, Irvine

Phone: 714-456-6550

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place