Trial Outcomes & Findings for A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer (NCT NCT01057589)
NCT ID: NCT01057589
Last Updated: 2013-09-18
Results Overview
PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines defined as the time from the date of first dose of study drug to first documented objective progressive disease (PD) or death from any cause. PD is defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Baseline to date of PD or death up to 18.7 months
Results posted on
2013-09-18
Participant Flow
Participant milestones
| Measure |
Pemetrexed + Cisplatin + Cetuximab
Pemetrexed 500 milligram per meter squared (mg/m\^2) administered by intravenous (IV) infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles.
At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months.
Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
66
|
Reasons for withdrawal
| Measure |
Pemetrexed + Cisplatin + Cetuximab
Pemetrexed 500 milligram per meter squared (mg/m\^2) administered by intravenous (IV) infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles.
At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months.
Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Overall Study
Disease Progression
|
35
|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Physician Decision
|
8
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Sponsor Decision
|
1
|
|
Overall Study
Death
|
8
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Pemetrexed Cisplatin Cetuximab
n=66 Participants
Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Age Continuous
|
61.8 years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
66 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
8 participants
n=5 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
13 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to date of PD or death up to 18.7 monthsPopulation: Protocol Qualified (PQ) Population: all randomized and treated participants
PFS based on Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines defined as the time from the date of first dose of study drug to first documented objective progressive disease (PD) or death from any cause. PD is defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Pemetrexed Cisplatin Cetuximab
n=66 Participants
Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Progression Free Survival (PFS)
|
4.4 months
Interval 3.6 to 5.4
|
SECONDARY outcome
Timeframe: Baseline to date of death up to 18.7 monthsPopulation: PQ Population: all randomized and treated participants
OS defined as the time from the date of first dose of study drug to the date to death from any cause.
Outcome measures
| Measure |
Pemetrexed Cisplatin Cetuximab
n=66 Participants
Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Overall Survival (OS)
|
9.7 months
Interval 6.5 to 13.1
|
SECONDARY outcome
Timeframe: Date of first response to PD (up to 18.7 months)Population: PQ Population: all randomized and treated participants with evaluable data; 6 participant's results were unknown.
CR and PR based on RECIST Guidelines: CR is defined as the disappearance of all tumor lesions; PR is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or the complete disappearance of target lesions, with persistence (but not worsening) of one or more nontarget lesions and the appearance of no new lesions. PD is defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Pemetrexed Cisplatin Cetuximab
n=58 Participants
Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Percent of Participants With a Partial Response (PR) or a Complete Response (CR)
|
29.3 percentage of participants
Interval 18.1 to 42.7
|
SECONDARY outcome
Timeframe: Baseline, End of Triplet Combination Therapy (up to Cycle 6 [4.2 months]), End of Maintenance Therapy (up to 18.7 months)Population: PQ Population: all randomized and treated participants with evaluable data for each category
Vertical VAS - a 20 millimeter (mm), fractionated scale in the form of a thermometer with endpoints of 0 (worst imaginable health state) and 100 (best imaginable health state). Participants used the EQ-5D VAS scale to rate their overall health on the day the questionnaire was administered. Possible change values range from -100 (best imaginable health at baseline changed to worst possible health at visit) to 100 (worst possible health at baseline changed to best possible health at visit).
Outcome measures
| Measure |
Pemetrexed Cisplatin Cetuximab
n=26 Participants
Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy
Change at End of Maintenance Therapy (n=11)
|
-10.6 units on a scale
Standard Deviation 21.51
|
|
Change From Baseline in Participant Reported European-Quality of Life 5 Dimension Instrument (EQ-5D) Visual Analog Scale (VAS) at End of Triplet Combination Therapy and End of Maintenance Therapy
Change at End of Triplet Therapy (n=23)
|
-1.2 units on a scale
Standard Deviation 14.28
|
SECONDARY outcome
Timeframe: Baseline, End of Triplet Combination Therapy (up to 6 cycles [4.2 months]) , End of Maintenance Therapy (up to 18.7 months)Population: PQ Population: all randomized and treated participants with EQ-5D data at respective timepoint.
EQ-5D Index is derived by converting the Descriptive System (participant is required to rate health by checking 1 \[no limitation\], 2 \[some limitation\] or 3 \[severe or complete limitation\] in 5 dimensions \[mobility, self-care, usual activities, pain/comfort and anxiety/depression\]) to a single summary index. A utility value assigned to each individual's health state based on the absence or presence of moderate or severe problems in the 5 dimensions. A regression equation defines a utility value for these health states. The possible values for health utility ranged from -0.59 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 0 represents death and 1 represents the best possible health state. Possible change values range from -1.59 (no problems at baseline to severe problems at visit) to 1.59 (severe problems at baseline to no problems at visit).
Outcome measures
| Measure |
Pemetrexed Cisplatin Cetuximab
n=34 Participants
Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy
Change at End of Maintenance Therapy (n=15)
|
-0.02 units on a scale
Standard Deviation 0.291
|
|
Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy
Change at End of Triplet Therapy (n=29)
|
0.05 units on a scale
Standard Deviation 0.230
|
SECONDARY outcome
Timeframe: Baseline, Triplet Combination Therapy Cycles 2, 4, 6 (cycle = 21 days) and optional Maintenance Therapy Cycles 1, 3, 5 and 7 (cycle = 21 days)Population: PQ Population: all randomized and treated participants with evaluable data at respective timepoint.
PSS-HNC is a clinician-rated instrument designed to measure speaking and eating disabilities of participants with head and neck cancer and consists of 3 subscales: Normalcy of Diet (NOD) subscale measures the ability of the participants to eat a normal diet, scale ranged from 0 (non-oral feeding) to 100 (unrestricted diet); Understandability of Speech (UOS)subscale measured the degree a clinician was able to understand the participant's speech, subscale ranged from 0 (never understandable) to 100 (always understandable); Eating in Public (EIP) subscale, rating based on clinician question to the participant to report who he/she eats with and in what setting, subscale ranged from 0 (always eats alone) to 100 (no restriction of place, food, or companion). Change from baseline: negative value represents a decrease in function and a positive value represents an increase in function.
Outcome measures
| Measure |
Pemetrexed Cisplatin Cetuximab
n=54 Participants
Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
EIP-Change at Triplet Cycle 4 (n=37)
|
-6.8 units on a scale
Standard Deviation 29.3
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
UOS-Change at Triplet Cycle 6 (n=24)
|
-10.4 units on a scale
Standard Deviation 22.0
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
NOD-Change at Triplet Cycle 2 (n=53)
|
-0.4 units on a scale
Standard Deviation 20.8
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
NOD-Change at Triplet Cycle 4 (n=41)
|
3.9 units on a scale
Standard Deviation 24.2
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
NOD-Change at Triplet Cycle 6 (n=24)
|
3.3 units on a scale
Standard Deviation 23.5
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
NOD-Change at Maintenance Cycle 1 (n=23)
|
0.4 units on a scale
Standard Deviation 29.9
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
NOD-Change at Maintenance Cycle 3 (n=10)
|
-1.0 units on a scale
Standard Deviation 21.3
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
NOD-Change at Maintenance Cycle 5 (n=6)
|
8.3 units on a scale
Standard Deviation 20.4
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
NOD-Change at Maintenance Cycle 7 (n=5)
|
-8.0 units on a scale
Standard Deviation 11.0
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
EIP-Change at Triplet Cycle 2 (n=46)
|
2.7 units on a scale
Standard Deviation 25.4
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
EIP-Change at Triplet Cycle 6 (n=22)
|
-3.4 units on a scale
Standard Deviation 20.8
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
EIP-Change at Maintenance Cycle 1 (n=23)
|
-8.7 units on a scale
Standard Deviation 38.1
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
EIP-Change at Maintenance Cycle 3 (n=10)
|
-10.0 units on a scale
Standard Deviation 21.1
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
EIP-Change at Maintenance Cycle 5 (n=6)
|
-4.2 units on a scale
Standard Deviation 24.6
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
EIP-Change at Maintenance Cycle 7 (n=5)
|
-15.0 units on a scale
Standard Deviation 22.4
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
UOS-Change at Triplet Cycle 2 (n=53)
|
0.5 units on a scale
Standard Deviation 18.0
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
UOS-Change at Triplet Cycle 4 (n=41)
|
-4.3 units on a scale
Standard Deviation 17.6
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
UOS-Change at Maintenance Cycle 1 (n=23)
|
-1.1 units on a scale
Standard Deviation 14.1
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
UOS-Change at Maintenance Cycle 3 (n=10)
|
-2.5 units on a scale
Standard Deviation 7.9
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
UOS-Change at Maintenance Cycle 5 (n=6)
|
-12.5 units on a scale
Standard Deviation 34.5
|
|
Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)
UOS-Change at Maintenance Cycle 7 (n=5)
|
-15.0 units on a scale
Standard Deviation 33.5
|
Adverse Events
Pemetrexed Cisplatin Cetuximab
Serious events: 45 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pemetrexed Cisplatin Cetuximab
n=66 participants at risk
Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
4/66 • Number of events 7
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
3/66 • Number of events 3
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.5%
3/66 • Number of events 6
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
3/66 • Number of events 5
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
1/66 • Number of events 1
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.5%
1/66 • Number of events 1
|
|
Congenital, familial and genetic disorders
Fanconi syndrome
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
4/66 • Number of events 5
|
|
Gastrointestinal disorders
Dysphagia
|
3.0%
2/66 • Number of events 2
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Subileus
|
1.5%
1/66 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
2/66 • Number of events 3
|
|
General disorders
Asthenia
|
3.0%
2/66 • Number of events 2
|
|
General disorders
Death
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Fatigue
|
3.0%
2/66 • Number of events 2
|
|
General disorders
General physical health deterioration
|
3.0%
2/66 • Number of events 2
|
|
General disorders
Implant site haemorrhage
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Malaise
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Medical device complication
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Medical device pain
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
3.0%
2/66 • Number of events 2
|
|
General disorders
Performance status decreased
|
1.5%
1/66 • Number of events 1
|
|
General disorders
Pyrexia
|
4.5%
3/66 • Number of events 4
|
|
Immune system disorders
Anaphylactic shock
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Catheter site infection
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Endocarditis
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Infection
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Oesophageal candidiasis
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
10.6%
7/66 • Number of events 7
|
|
Infections and infestations
Postoperative wound infection
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Pseudomonal sepsis
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
4.5%
3/66 • Number of events 4
|
|
Infections and infestations
Sepsis
|
3.0%
2/66 • Number of events 2
|
|
Infections and infestations
Septic embolus
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Septic shock
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Staphylococcal sepsis
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Subcutaneous abscess
|
1.5%
1/66 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
3.0%
2/66 • Number of events 2
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.5%
1/66 • Number of events 1
|
|
Investigations
Blood creatinine increased
|
1.5%
1/66 • Number of events 1
|
|
Investigations
Weight decreased
|
3.0%
2/66 • Number of events 2
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
3/66 • Number of events 4
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/66 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.0%
2/66 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.0%
2/66 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
1/66 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour embolism
|
1.5%
1/66 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
1.5%
1/66 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Asterixis
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Cerebral infarction
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Cerebral ischaemia
|
1.5%
1/66 • Number of events 1
|
|
Nervous system disorders
Syncope
|
4.5%
3/66 • Number of events 3
|
|
Nervous system disorders
Transient ischaemic attack
|
1.5%
1/66 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
4.5%
3/66 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.0%
2/66 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
2/66 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.5%
1/66 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
3/66 • Number of events 3
|
|
Vascular disorders
Haemorrhage
|
1.5%
1/66 • Number of events 1
|
|
Vascular disorders
Hypotension
|
7.6%
5/66 • Number of events 5
|
Other adverse events
| Measure |
Pemetrexed Cisplatin Cetuximab
n=66 participants at risk
Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
39.4%
26/66 • Number of events 30
|
|
Blood and lymphatic system disorders
Leukopenia
|
39.4%
26/66 • Number of events 36
|
|
Blood and lymphatic system disorders
Neutropenia
|
39.4%
26/66 • Number of events 35
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
24.2%
16/66 • Number of events 19
|
|
Eye disorders
Conjunctivitis
|
9.1%
6/66 • Number of events 7
|
|
Eye disorders
Lacrimation increased
|
6.1%
4/66 • Number of events 5
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
4/66 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.6%
7/66 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
37.9%
25/66 • Number of events 29
|
|
Gastrointestinal disorders
Diarrhoea
|
30.3%
20/66 • Number of events 28
|
|
Gastrointestinal disorders
Dyspepsia
|
15.2%
10/66 • Number of events 11
|
|
Gastrointestinal disorders
Dysphagia
|
18.2%
12/66 • Number of events 13
|
|
Gastrointestinal disorders
Nausea
|
40.9%
27/66 • Number of events 33
|
|
Gastrointestinal disorders
Stomatitis
|
30.3%
20/66 • Number of events 24
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
22/66 • Number of events 26
|
|
General disorders
Asthenia
|
21.2%
14/66 • Number of events 25
|
|
General disorders
Chills
|
6.1%
4/66 • Number of events 4
|
|
General disorders
Fatigue
|
60.6%
40/66 • Number of events 45
|
|
General disorders
Mucosal inflammation
|
33.3%
22/66 • Number of events 35
|
|
General disorders
Oedema peripheral
|
10.6%
7/66 • Number of events 9
|
|
General disorders
Pain
|
6.1%
4/66 • Number of events 5
|
|
General disorders
Pyrexia
|
18.2%
12/66 • Number of events 12
|
|
Infections and infestations
Folliculitis
|
9.1%
6/66 • Number of events 6
|
|
Infections and infestations
Oral candidiasis
|
6.1%
4/66 • Number of events 5
|
|
Investigations
Creatinine renal clearance decreased
|
6.1%
4/66 • Number of events 4
|
|
Investigations
Weight decreased
|
15.2%
10/66 • Number of events 10
|
|
Investigations
Weight increased
|
6.1%
4/66 • Number of events 6
|
|
Metabolism and nutrition disorders
Decreased appetite
|
43.9%
29/66 • Number of events 31
|
|
Metabolism and nutrition disorders
Dehydration
|
6.1%
4/66 • Number of events 4
|
|
Metabolism and nutrition disorders
Fluid retention
|
9.1%
6/66 • Number of events 10
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.6%
5/66 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
30.3%
20/66 • Number of events 26
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
31.8%
21/66 • Number of events 24
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.1%
6/66 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.1%
4/66 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
7.6%
5/66 • Number of events 5
|
|
Nervous system disorders
Dizziness
|
22.7%
15/66 • Number of events 18
|
|
Nervous system disorders
Dysgeusia
|
10.6%
7/66 • Number of events 8
|
|
Nervous system disorders
Neuropathy peripheral
|
9.1%
6/66 • Number of events 6
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.1%
4/66 • Number of events 4
|
|
Nervous system disorders
Syncope
|
9.1%
6/66 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
10.6%
7/66 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
6/66 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
6.1%
4/66 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
11/66 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.6%
9/66 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.6%
5/66 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Acne
|
16.7%
11/66 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
11/66 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.6%
5/66 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.2%
14/66 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Erythema
|
15.2%
10/66 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
7.6%
5/66 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.6%
5/66 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash
|
47.0%
31/66 • Number of events 37
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
16.7%
11/66 • Number of events 12
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.1%
4/66 • Number of events 4
|
|
Vascular disorders
Hypotension
|
10.6%
7/66 • Number of events 8
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60