Trial Outcomes & Findings for Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer (NCT NCT00509665)

Last Updated: 2018-07-12

Results Overview

Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

Every 6 weeks from the time of initial treatment for up to 8 months

Results posted on

2018-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Gemcitabine+Doxorubicin doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabine+Doxorubicin n=18 Participants doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Age, Continuous	57 years n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants
Race (NIH/OMB) White	11 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	18 participants n=93 Participants

PRIMARY outcome

Timeframe: Every 6 weeks from the time of initial treatment for up to 8 months

Population: patients who were on study at the time of response assessment

Outcome measures

Outcome measures
Measure	Gemcitabine+Doxorubicin n=17 Participants doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Response Rate	4 participants

SECONDARY outcome

Timeframe: Every 6 weeks for up to 8 months

Population: data for this endpoint was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through the end of follow up, for an average of 8 months

Population: Only patients who had re-staging scans are included in the number of participants analyzed.

Outcome measures

Outcome measures
Measure	Gemcitabine+Doxorubicin n=17 Participants doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Progression-free Survival	1.6 months Interval 1.4 to 4.2

SECONDARY outcome

Timeframe: From the time of initial therapy until the time of death.

Outcome measures

Outcome measures
Measure	Gemcitabine+Doxorubicin n=18 Participants doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Overall Survival	5.6 Months Interval 3.8 to 18.2

SECONDARY outcome

Timeframe: from time of initial treatment until end of study, an average of 6 months

Population: Patients who were treated on study and had greater than grade 2 toxicity.

Outcome measures

Outcome measures
Measure	Gemcitabine+Doxorubicin n=18 Participants doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Number of Patients Who Had Greater Than Grade 2 Toxicity	10 Participants

SECONDARY outcome

Timeframe: prior to first dose of drug and every 6 weeks up to 6 months

Population: data for this endpoint was not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: prior to first dose of drug and every 6 weeks for up to 6 months

Population: Data for this endpoint was not collected

Outcome measures

Outcome data not reported

Adverse Events

Gemcitabine+Doxorubicin

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gemcitabine+Doxorubicin n=18 participants at risk doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
Blood and lymphatic system disorders neutropenia	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months

Other adverse events

Other adverse events
Measure	Gemcitabine+Doxorubicin n=18 participants at risk doxorubicin hydrochloride: given as 25mgm2 IV on days 1 and 8 of each 21-day cycle. gemcitabine hydrochloride: given as 100mg/m2 IV over days 1 and 8 of each 21 day cycle
General disorders fatigue	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months
Blood and lymphatic system disorders neutropenia	22.2% 4/18 • Number of events 4 • Prior to each cycle while on treatment for an average of 6 months
Blood and lymphatic system disorders leukopenia	16.7% 3/18 • Number of events 3 • Prior to each cycle while on treatment for an average of 6 months
Blood and lymphatic system disorders anemia	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months
Blood and lymphatic system disorders thrombocytopenia	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months
Respiratory, thoracic and mediastinal disorders cough	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months
Metabolism and nutrition disorders hypocalcemia	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months
Metabolism and nutrition disorders hypophosphatemia	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months
Metabolism and nutrition disorders hyponatremia	11.1% 2/18 • Number of events 2 • Prior to each cycle while on treatment for an average of 6 months
Gastrointestinal disorders nausea	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months
Gastrointestinal disorders vomitting	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months
Infections and infestations infection	11.1% 2/18 • Number of events 2 • Prior to each cycle while on treatment for an average of 6 months
Vascular disorders DVT	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months
Gastrointestinal disorders dysphagia	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months
Metabolism and nutrition disorders hypokalemia	5.6% 1/18 • Number of events 1 • Prior to each cycle while on treatment for an average of 6 months

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