Trial Outcomes & Findings for A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC) (NCT NCT00589667)

Last Updated: 2014-04-02

Results Overview

To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

2 years

Results posted on

2014-04-02

Participant Flow

Protocol Open to Accrual 09/08/1998 Protocol Closed to Accrual 07/22/2008 Primary Completion Date 07/13/2010 Recruitment Location is the medical clinic.

Participant milestones

Participant milestones
Measure	Pemetrexed Plus Gemcitabine Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
Overall Study STARTED	26
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Pemetrexed Plus Gemcitabine Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pemetrexed Plus Gemcitabine n=26 Participants Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	52.5 years STANDARD_DEVIATION 43.13351365 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: All assessable patients as indicated in the protocol.

Outcome measures

Outcome measures
Measure	Pemetrexed Plus Gemcitabine n=25 Participants Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
Overall Objective Response Partial Response	4 participants
Overall Objective Response Stable Disease	18 participants
Overall Objective Response Progression of Disease	2 participants
Overall Objective Response Response not available	1 participants

SECONDARY outcome

Timeframe: 2 years

Population: There were 25 assessable patients as described in the protocol.

To determine the median overall survival for patients with recurrent or metastatic Head and Neck Squamous Cell Carcinoma treated with pemetrexed and gemcitabine.

Outcome measures

Outcome measures
Measure	Pemetrexed Plus Gemcitabine n=25 Participants Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
Median Overall Survival	8.8 months Interval 1.9 to 30.9

Adverse Events

Pemetrexed Plus Gemcitabine

Serious events: 12 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pemetrexed Plus Gemcitabine n=25 participants at risk Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
Metabolism and nutrition disorders Hyponatremia	12.0% 3/25 • Number of events 4
Immune system disorders Immune system disorder	4.0% 1/25 • Number of events 1
Metabolism and nutrition disorders Hypercalcemia	12.0% 3/25 • Number of events 5
Psychiatric disorders Confusion	4.0% 1/25 • Number of events 1
Metabolism and nutrition disorders Dehydration	8.0% 2/25 • Number of events 2
Respiratory, thoracic and mediastinal disorders Dyspnea	12.0% 3/25 • Number of events 5
General disorders Edema-Head and Neck	4.0% 1/25 • Number of events 2
General disorders Edema-limb	4.0% 1/25 • Number of events 1
General disorders Fatigue	8.0% 2/25 • Number of events 3
Blood and lymphatic system disorders Febrile Neutropenia	4.0% 1/25 • Number of events 1
General disorders Fever	8.0% 2/25 • Number of events 3
Investigations Hemoglobin	8.0% 2/25 • Number of events 2
Vascular disorders Hypotension	8.0% 2/25 • Number of events 3
Infections and infestations Skin Infection	4.0% 1/25 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	4.0% 1/25 • Number of events 1
Metabolism and nutrition disorders Hypomagnesemia	4.0% 1/25 • Number of events 1
Gastrointestinal disorders Mucositis-esophagus	4.0% 1/25 • Number of events 1
Investigations Neutrophil count decrease	12.0% 3/25 • Number of events 3
Respiratory, thoracic and mediastinal disorders Pleuritic pain	4.0% 1/25 • Number of events 1
Metabolism and nutrition disorders Hypophosphatemia	4.0% 1/25 • Number of events 2
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.0% 1/25 • Number of events 1
Metabolism and nutrition disorders Hypokalemia	4.0% 1/25 • Number of events 2
Psychiatric disorders Psychosis	4.0% 1/25 • Number of events 1
Respiratory, thoracic and mediastinal disorders Respiratory disorder	4.0% 1/25 • Number of events 1
Nervous system disorders Syncope	4.0% 1/25 • Number of events 1
Vascular disorders Thrombosis	8.0% 2/25 • Number of events 2

Other adverse events

Other adverse events
Measure	Pemetrexed Plus Gemcitabine n=25 participants at risk Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
Investigations Alanine aminotransferase increased	8.0% 2/25 • Number of events 2
General disorders Fatigue	12.0% 3/25 • Number of events 3
Blood and lymphatic system disorders Anemia	40.0% 10/25 • Number of events 51
Investigations INR increased	8.0% 2/25 • Number of events 19
Investigations White blood cell decreased	20.0% 5/25 • Number of events 26
Investigations Lymphocyte count decreased	80.0% 20/25 • Number of events 166
Investigations Neutrophil count decreased	12.0% 3/25 • Number of events 13
Metabolism and nutrition disorders Hypophosphatemia	8.0% 2/25 • Number of events 7
Investigations Platelet count decreased	8.0% 2/25 • Number of events 11
Skin and subcutaneous tissue disorders Rash	8.0% 2/25 • Number of events 2

Additional Information

David Pfister, MD

Memorial Sloan-Kettering Cancer Center

Phone: 646-888-4232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place