Trial Outcomes & Findings for Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer (NCT NCT00503997)

Last Updated: 2012-05-10

Results Overview

RECIST response categories: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

at 8 weeks

Results posted on

2012-05-10

Participant Flow

The trial was open to accrual from 12/13/2006 to 4/9/2008.

This study consented 42 patients. One patient was found ineligible.

Participant milestones

Participant milestones
Measure	Pemetrexed/Oxaliplatin Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
Overall Study STARTED	42
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Pemetrexed/Oxaliplatin Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
Overall Study disease progression	1
Overall Study Adverse Event	5
Overall Study Death	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pemetrexed/Oxaliplatin n=42 Participants Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=99 Participants
Age, Categorical >=65 years	5 Participants n=99 Participants
Age Continuous	56 years STANDARD_DEVIATION 1 • n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	35 Participants n=99 Participants
Region of Enrollment United States	42 participants n=99 Participants

PRIMARY outcome

Timeframe: at 8 weeks

Outcome measures

Outcome measures
Measure	Pemetrexed/Oxaliplatin n=42 Participants Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
Patient Response to Treatment Measured by RECIST Criteria Complete Response	1 participants
Patient Response to Treatment Measured by RECIST Criteria Partial Response	18 participants
Patient Response to Treatment Measured by RECIST Criteria Stable Disease	19 participants
Patient Response to Treatment Measured by RECIST Criteria Progressive Disease	2 participants
Patient Response to Treatment Measured by RECIST Criteria Not Evaluable	2 participants

Adverse Events

Pemetrexed/Oxaliplatin

Serious events: 7 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pemetrexed/Oxaliplatin n=42 participants at risk Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
Gastrointestinal disorders Diarrhea	2.4% 1/42 • Number of events 1
Gastrointestinal disorders Esophagus pain	2.4% 1/42 • Number of events 1
Investigations ANC/AGC	2.4% 1/42 • Number of events 1
Ear and labyrinth disorders hearing loss, sudden	2.4% 1/42 • Number of events 1
Infections and infestations infection, port-a-cath	2.4% 1/42 • Number of events 1
Vascular disorders DVT/PE	2.4% 1/42 • Number of events 1
Blood and lymphatic system disorders myelosupression	2.4% 1/42 • Number of events 1
Respiratory, thoracic and mediastinal disorders pneumonia	2.4% 1/42 • Number of events 1
Metabolism and nutrition disorders acidosis	2.4% 1/42 • Number of events 1
Blood and lymphatic system disorders febrile neutropenia	2.4% 1/42 • Number of events 1
Metabolism and nutrition disorders dehydration	2.4% 1/42 • Number of events 1
Infections and infestations sepsis	2.4% 1/42 • Number of events 1
Metabolism and nutrition disorders malnutrition	2.4% 1/42 • Number of events 1
Gastrointestinal disorders obstructed PEG tube	2.4% 1/42 • Number of events 1
Respiratory, thoracic and mediastinal disorders tracheostomy tube changed	2.4% 1/42 • Number of events 1
Renal and urinary disorders cystitis	2.4% 1/42 • Number of events 1
Respiratory, thoracic and mediastinal disorders dyspnea	4.8% 2/42 • Number of events 2
Investigations weight loss	2.4% 1/42 • Number of events 1
Infections and infestations urinary tract infection	2.4% 1/42 • Number of events 1

Other adverse events

Other adverse events
Measure	Pemetrexed/Oxaliplatin n=42 participants at risk Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
Metabolism and nutrition disorders hypokalemia	16.7% 7/42 • Number of events 7
Gastrointestinal disorders diarrhea	9.5% 4/42 • Number of events 4
General disorders neutropenia	16.7% 7/42 • Number of events 7
Gastrointestinal disorders dehydration	4.8% 2/42 • Number of events 2
Infections and infestations infection	4.8% 2/42 • Number of events 2

Additional Information

Jill Gilbert, M.D.

Vanderbilt-Ingram Cancer Center

Phone: 615-343-4677

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place