Symptoms and General Pathology

All Conditions

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Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

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Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

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Laryngeal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

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Carboplatin

Pemetrexed

Cetuximab

Cisplatin

Parathyroid Hormone

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Folinic Acid

Folate

Vitamin B9

Cycle 1:

Week 1 - Cetuximab 400 milligrams/square meter (mg/m²) on Day 1; Pemetrexed 500 mg/m² on Day 1; Carboplatin area under curve (AUC) 5 on Day 1 or Cisplatin 75 mg/m² on Day 1

Week 2 - Cetuximab 250 mg/m² on Day 1

Week 3 - Cetuximab 250 mg/m² on Day 1

Cycle 2-6:

Week 1 - Cetuximab 250 mg/m² on Day 1; Pemetrexed 500 mg/m² on Day 1; Carboplatin AUC 5 on Day 1 or Cisplatin 75 mg/m² on Day 1

Week 2 - Cetuximab 250 mg/m² on Day 1

Week 3 - Cetuximab 250 mg/m² on Day 1

Following Cycle 6, Cetuximab Monotherapy: 250 mg/m² intravenously weekly on Day 1

Administered intravenously, for maximum of 6 cycles.

Administered intravenously in combination therapy, for a maximum of 6 cycles.

After the completion of 6 cycles, participants who have not experienced disease progression will continue on cetuximab monotherapy until disease progression.

Administered intravenously, for a maximum of 6 cycles

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The purpose of this study is to look for an improvement in progression free survival with the combination of pemetrexed, carboplatin (or cisplatin) and cetuximab in participants with recurrent or metastatic squamous cell carcinoma of the head and neck.

A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

Phase 2 Study of Pemetrexed in Combination With Carboplatin or Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.

PFS was defined as the duration from the date of enrollment to the first date of documented objective progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who were not known to have died or to have had objective PD at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.

OS is defined as the duration from the date of enrollment to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the date of last contact prior to that cut-off date.

PR or CR is classified by the investigators according to RECIST criteria version 1.0. PR is a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions; CR is the disappearance of all target and non-target lesions. Percentage of participants having a PR or CR is calculated as a total number of participants with PR or CR from enrollment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.

EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. A regression equation defines a utility value for these health states to generate an index score. The possible values for index score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. The EQ-5D Visual Analog Scale (VAS) is used to record a participant's rating for his/her current health-related quality of life state on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).

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, subscale ranges from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) subscale measures the degree a clinician is able to understand the participant's speech, subscale ranges from 0 (never understandable) to 100 (always understandable); eating in public (EIP) subscale, rating based on the participant's response to the questions of whom he/she eats with and in what setting, subscale ranges 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.

Eli Lilly and Company

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

Cetuximab + Pemetrexed + Carboplatin

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

Cetuximab + Pemetrexed + Cisplatin

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

Cetuximab + Pemetrexed + Carboplatin/Cisplatin

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Index Score (n=47)

Visual Analog Scale (VAS) Score (n=47)

Participants assessed health-related QoL in 5 D (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) as no problems/some or moderate problems/extreme problems. A regression equation defines a utility value for these health states to generate an index score from -0.594 (severe problems in all 5 D) to 1 (no problem in all 5 D) where 1=best possible health state. EQ-5D VAS rates participant's current health-related QoL on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).

European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)

NOD (n=57)

UOS (n=57)

EIP (n=57)

Clinician measured speaking and eating disabilities of HNC participants that consists 3 subscales: normalcy of diet (NOD) measures ability of eating a normal diet, scale from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) measures the degree a clinician was able to understand participant's speech, scale from 0 (never understandable) to 100 (always understandable); eating in public (EIP) is based on clinician's question to the participant, scale from 0 (always eats alone) to 100 (no restriction of place, food, or companion).

Performance Status Scale for Head and Neck Cancer (PSS-HNC)

All enrolled participants who received at least 1 dose of study drug.

Efficacy populations excluded data from a noncompliant site (11 participants).

Chief Medical Officer

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

All treated participants excluding those from a noncompliant study site. The number of participants censored was 9.

Progression-Free Survival (PFS)

All treated participants excluding those from a noncompliant study site. The number of participants censored was 22.

Overall Survival (OS)

All treated participants excluding those from a noncompliant study site.

Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)

Change in Index Score at Cycle 2 (n=43)

Change in Index Score at Cycle 4 (n=29)

Change in Index Score at Cycle 6 (n=24)

Change in Index Score at monotherapy Cycle2 (n=14)

Change in Index Score at monotherapy Cycle 4 (n=7)

Change in VAS Score at Cycle 2 (n=41)

Change in VAS Score at Cycle 4 (n=28)

Change in VAS Score at Cycle 6 (n=21)

Change in VAS Score at monotherapy Cycle 2 (n=14)

Change in VAS Score at monotherapy Cycle 4 (n=7)

All treated participants who completed the EQ-5D-3L and VAS at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.

Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)

Change in NOD at Cycle 2 (n=52)

Change in UOS at Cycle 2 (n=52)

change in EIP at Cycle 2 (n=52)

Change in NOD at Cycle 4 (n=34)

Change in UOS at Cycle 4 (n=35)

Change in EIP at Cycle 4 (n=34)

Change in NOD at Cycle 6 (n=28)

Change in UOS at Cycle 6 (n=28)

Change in EIP at Cycle 6 (n=28)

Change in NOD at monotherapy Cycle 2 (n=16)

Change in UOS at monotherapy Cycle 2 (n=16)

Change in EIP at monotherapy Cycle 2 (n=17)

Change in NOD at monotherapy Cycle 4 (n=9)

Change in UOS at monotherapy Cycle 4 (n=9)

Change in EIP at monotherapy Cycle 4 (n=9)

All treated participants who had PSS-HNC assessments at baseline and in Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4. Exclude those from a noncompliant study site.

Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)

Due to AE while on treatment

Due to PD during 30-day FU

All enrolled participants who received at least 1 dose of any study drug.

Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)

Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.

Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.

Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.

Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

Overall Study

Gland and Hormone Related Diseases

Thyroid Diseases

Vitamin B 12

Hydroxocobalamin

Trace Elements

Methylcobalamin

Vitamin B12

Cobalamin

Cyanocobalamin

Participants will receive pemetrexed,cisplatin and cetuximab for up to 6 cycles (21 days per cycle) followed by optional maintenance of pemetrexed and cetuximab until disease progression. Optional maintenance therapy is permitted after at least 4 cycles of triplet combination therapy have been given. Cetuximab will be administered as an initial dose of 400 milligram per meter squared (mg/m\^2) intravenous (IV) infusion and as a 250 mg/m\^2 IV weekly dose thereafter.

As Standard of care dietary supplements included: 350 to 1000 micrograms (µg) oral Folic Acid 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed and 1000 µg vitamin B12 intramuscular injection (IM) during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.

Triplet Combination Therapy: 500 mg/m\^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles

Maintenance Therapy: 500mg/m\^2 administered intravenously on Day 1 of 21 day cycle until disease progression or unacceptable toxicity

Triplet Combination Therapy: 400 mg/m\^2 administered intravenously on Day 1 of 21 day cycle for 1 cycle; 250 mg/m\^2 administered IV infusion on Day 1 of 21 day cycle and then weekly for up to 6 cycles.

Maintenance Therapy: 250 mg/m\^2 administered intravenously on Day 1 of 21 day cycle and then weekly until disease progression or unacceptable toxicity

Triplet Combination Therapy: 75mg/m\^2 administered intravenously on Day 1 of 21 day cycle for up to 6 cycles.

Standard of care dietary supplements: 350 to 1000 µg orally 5 times a day for the 7 days preceding the first dose of first dose of pemetrexed and continuing throughout treatment and for 21 days after the last dose of pemetrexed.

Standard of care dietary supplements: 1000 µg IM during the week preceding the first dose of pemetrexed and every 9 weeks thereafter.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5PM Eastern time (UTC/GMT - 5 hours, EST

The purpose of this trial is to estimate progression free survival in patients with recurrent or metastatic head and neck cancer that have not received chemotherapy in this setting.

A 12 patient safety lead will evaluate side effects in patients receiving at least 2 cycles of the combination pemetrexed, cisplatin and cetuximab.

A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer

Phase 2 Study of Pemetrexed in Combination With Cisplatin and Cetuximab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

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.

OS defined as the time from the date of first dose of study drug to the date to death from any cause.

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.

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).

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).

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.

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.

Pemetrexed Cisplatin Cetuximab

Age Continuous

White

Race/Ethnicity, Customized

Belgium

France

Germany

Italy

Spain

United Kingdom

Protocol Qualified (PQ) Population: all randomized and treated participants

Progression Free Survival (PFS)

PQ Population: all randomized and treated participants

PQ Population: all randomized and treated participants with evaluable data; 6 participant's results were unknown.

Percent of Participants With a Partial Response (PR) or a Complete Response (CR)

Change at End of Triplet Therapy (n=23)

Change at End of Maintenance Therapy (n=11)

PQ Population: all randomized and treated participants with evaluable data for each category

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=29)

Change at End of Maintenance Therapy (n=15)

PQ Population: all randomized and treated participants with EQ-5D data at respective timepoint.

Change From Baseline in Participant Reported EQ-5D Utility Score at End of Triplet Combination Therapy and End of Maintenance Therapy

NOD-Change at Triplet Cycle 2 (n=53)

NOD-Change at Triplet Cycle 4 (n=41)

NOD-Change at Triplet Cycle 6 (n=24)

NOD-Change at Maintenance Cycle 1 (n=23)

NOD-Change at Maintenance Cycle 3 (n=10)

NOD-Change at Maintenance Cycle 5 (n=6)

NOD-Change at Maintenance Cycle 7 (n=5)

EIP-Change at Triplet Cycle 2 (n=46)

EIP-Change at Triplet Cycle 4 (n=37)

EIP-Change at Triplet Cycle 6 (n=22)

EIP-Change at Maintenance Cycle 1 (n=23)

EIP-Change at Maintenance Cycle 3 (n=10)

EIP-Change at Maintenance Cycle 5 (n=6)

EIP-Change at Maintenance Cycle 7 (n=5)

UOS-Change at Triplet Cycle 2 (n=53)

UOS-Change at Triplet Cycle 4 (n=41)

UOS-Change at Triplet Cycle 6 (n=24)

UOS-Change at Maintenance Cycle 1 (n=23)

UOS-Change at Maintenance Cycle 3 (n=10)

UOS-Change at Maintenance Cycle 5 (n=6)

UOS-Change at Maintenance Cycle 7 (n=5)

PQ Population: all randomized and treated participants with evaluable data at respective timepoint.

Change From Baseline in Performance Status Scale for Head and Neck Cancer Patients (PSS-HNC)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer	NCT01087970	Head and Neck N...	Pemetrexed Cetuximab Carboplatin Cisplatin	18 Years -	Eli Lilly and Company
A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer	NCT01057589	Head and Neck N...	Pemetrexed Cetuximab Cisplatin Folic Acid Vitamin B12	18 Years -	Eli Lilly and Company
A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer	NCT01057589	Head and Neck N...	Pemetrexed Cetuximab Cisplatin Folic Acid Vitamin B12	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for nose

Every month we try and update this database with for nose cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nose

Every month we try and update this database with for nose cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nose cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.