Trial Outcomes & Findings for A Study of Gemcitabine and Cisplatin/Carboplatin Plus Erlotinib in Patients With Nasopharyngeal Cancer (NCT NCT00603915)

Results Overview

From randomization to the first documented disease progression or death from any cause, whichever came first, assessed until all participants randomized to the study have progressed for died.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died.

Results posted on

2019-02-28

Participant Flow

Study was activated on 14-June-2006. Patients with nasopharyngeal carcinoma meeting the eligibility criteria specified in the protocol were enrolled.

Participant milestones

Participant milestones
Measure	GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Overall Study Physician Decision	1

Baseline Characteristics

A Study of Gemcitabine and Cisplatin/Carboplatin Plus Erlotinib in Patients With Nasopharyngeal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB n=20 Participants patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants
Age, Categorical >=65 years	4 Participants n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Region of Enrollment Canada	20 participants n=93 Participants
Performance Status 0	10 Participants n=93 Participants
Performance Status 1	10 Participants n=93 Participants

PRIMARY outcome

Timeframe: From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died.

From randomization to the first documented disease progression or death from any cause, whichever came first, assessed until all participants randomized to the study have progressed for died.

Outcome measures

Outcome measures
Measure	GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB n=19 Participants patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Progression Free Survival.	6.3 Months Interval 5.0 to 8.6

SECONDARY outcome

Timeframe: Measured every 2 cycles until the participant is off treatment.

Complete Response (CR): disappearance of all clinical and radiological evidence of tumour. Partial Response (PR): at least a 30% decrease in the sum of 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. Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions will also constitute progressive disease.

Outcome measures

Outcome measures
Measure	GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB n=19 Participants patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Number of Participants With the Responses Outlined Complete Response	0 Participants
Number of Participants With the Responses Outlined Partial Response	7 Participants
Number of Participants With the Responses Outlined Stable Disease	11 Participants
Number of Participants With the Responses Outlined Progressive Disease	1 Participants
Number of Participants With the Responses Outlined Inevaluable	1 Participants

Adverse Events

GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB

Serious events: 7 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB n=20 participants at risk patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	10.0% 2/20 • Number of events 2
Nervous system disorders Syncope	10.0% 2/20 • Number of events 3
Nervous system disorders Stroke	5.0% 1/20 • Number of events 1
General disorders Pyrexia	5.0% 1/20 • Number of events 1
Blood and lymphatic system disorders Platelets	5.0% 1/20 • Number of events 1
General disorders Dehydration	5.0% 1/20 • Number of events 1
Infections and infestations Pneumonia	10.0% 2/20 • Number of events 2

Other adverse events

Other adverse events
Measure	GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB n=20 participants at risk patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
Blood and lymphatic system disorders Hemoglobin decreased	95.0% 19/20 • Number of events 19
Blood and lymphatic system disorders Lymphocyte Count decreased	95.0% 19/20 • Number of events 19
Blood and lymphatic system disorders Leukocyte count decreased	90.0% 18/20 • Number of events 19
General disorders Fatigue	85.0% 17/20 • Number of events 17
Blood and lymphatic system disorders Neutrophil count decreased	90.0% 18/20 • Number of events 18
General disorders Pain	80.0% 16/20 • Number of events 16

Additional Information

Dr. Lillian Siu

Univerisity Health Network

Phone: 416-946-2911

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place