Head and Neck NeoplasmsPhase 2NCT01087970
A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer
A Phase 2 study testing Pemetrexed, Cetuximab and Carboplatin in people with Head and Neck Neoplasms, run by Eli Lilly and Company at 21 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Pemetrexed, Cetuximab and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 21 sitesUnited States
- Study dates
- Aug 2010to Aug 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic diagnosis of squamous cell head and neck cancer (HNC)
- Recurrent disease (locally advanced or metastatic) that is not amenable to local therapy, (i) with at least 6 months since completion of systemic therapy (chemotherapy or biological anticancer therapy), and (ii) with no more than 1 prior multimodal therapy (such as concurrent chemoradiation with or without sequential chemotherapy) for locally advanced HNC tumor, and (iii) with no prior systemic therapy (chemotherapy or biological anticancer therapy) for metastatic disease; OR
- Newly diagnosed distant metastatic disease (Stage IVc)
- Prior therapies:
- Radiation therapy must be completed at least 4 weeks before study enrollment. For palliative therapy, prior radiation therapy allowed <25% of the bone marrow and prior radiation to the whole pelvis is not allowed. Participants must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- Surgery (excluding prior diagnostic biopsy) must be completed at least 4 weeks before study enrollment. Participants must have fully recovered from any acute effects of surgery prior to study enrollment.
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- An estimated life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Biological tissue available for biomarker analysis on tumor tissue.
- Disease status must be measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST). The index lesion must not be in a prior irradiated area. Positron emission tomography (PET) scans and ultrasounds may not be used for lesion measurements.
- Participant compliance and geographic proximity that allow for adequate follow-up.
- Adequate organ function as defined by the following:
- Bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) greater than or equal to 1.5 × 10⁹/liter (L), platelets greater than or equal to 100 × 10⁹/L, and hemoglobin greater than or equal to 9 grams/deciliter (g/dL).
- Hepatic: bilirubin less than or equal to 1.5 × the upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) less than or equal to 3.0 × ULN (ALP, AST, and ALT less than or equal to 5.0 × ULN is acceptable if the liver has tumor involvement).
- Renal: calculated creatinine clearance (CrCl) greater than or equal to 45 milliliters/minute (mL/min).
- For women: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breast-feeding. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period.
Who cannot join
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Are receiving concurrent chronic systemic immune therapy, or chemotherapy for a disease other than cancer.
- Concurrent administration of any other antitumor therapy.
- Known prior allergic/hypersensitivity reaction to any of the components of the study treatment.
- Serious concomitant systemic disorder (for example, active infection) or psychiatric disorder that, in the opinion of the investigator, would compromise the participant's ability to complete the study.
- Have serious cardiac disease, such as symptomatic angina, unstable angina, or the history of myocardial infarction in the previous 12 months.
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- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Have had another primary malignancy other than HNC, unless that prior malignancy was treated at least 2 years previously with no evidence of recurrence. Exception: Participants with a history of in situ carcinoma of the cervix, nonmelanoma skin cancer, or low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed and treated less than 2 years previously.
- Nasopharyngeal, paranasal sinus, lip, or salivary gland cancer.
- Presence of clinically significant (by physical exam) third-space fluid collections; for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
- Have peripheral neuropathy of Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or higher.
- Have central nervous system (CNS) metastases (unless the participant has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy). Brain imaging is required in symptomatic participants to rule out brain metastases, but is not required in asymptomatic participants.
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
- Unable or unwilling to take folic acid, vitamin B12, or prophylactic corticosteroids.
- Recent (within 30 days before enrollment) or concurrent yellow fever vaccination.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Billings, Montana, 59102
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buffalo, New York, 14263
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chattanooga, Tennessee, 37404
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cincinnati, Ohio, 45242
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Columbia, South Carolina, 29210
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Detroit, Michigan, 48202
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fort Myers, Florida, 33916
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jonesboro, Arkansas, 72401
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Marietta, Georgia, 30060
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Memphis, Tennessee, 38119
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Nashville, Tennessee, 37203
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Orlando, Florida, 32806
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Richmond, Virginia, 23230
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint Louis Park, Minnesota, 55426
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Savannah, Georgia, 31405
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Scarborough, Maine, 04074
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seattle, Washington, 98109
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sioux Falls, South Dakota, 57104
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
The Bronx, New York, 10467
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Valdosta, Georgia, 31602
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Waterbury, Connecticut, 06708
About this study
Official title: 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
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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Pemetrexed, Cetuximab, Carboplatin, Cisplatin
- Keywords
- Pharynx, Larynx, Nose, Parathyroid
- Medical subject headings
- Head and Neck Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
Also called Alimta, LY231514
Administered intravenously, for maximum of 6 cycles.
CetuximabDrug
Also called Erbitux
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.
CarboplatinDrug
Administered intravenously, for a maximum of 6 cycles
CisplatinDrug
Administered intravenously, for a maximum of 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Triplet Combination Therapy | Experimental | 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 Receives: Drug: Pemetrexed; Drug: Cetuximab; Drug: Carboplatin; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
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.
Measured: From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)
Secondary outcomes (4)
Overall Survival (OS)
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.
Measured: From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months)
Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)
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.
Measured: From enrollment to objectively determined progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment until progressive disease)
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
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).
Measured: Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
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.
Measured: Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087970
- Sponsor's protocol ID
- 13491
- Other IDs
- H3E-MC-S132
- Status last verified
- Apr 2014
- First submitted
- 15 Mar 2010
- Last updated
- 19 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01087970
- Acronym / sponsor ID
- 13491
- Conditions
- Head and Neck Neoplasms
- Keywords
- Pharynx, Larynx, Nose, Parathyroid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Mar 2010 (estimated)
- Results
- Posted 19 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triplet Combination Therapy | Experimental | Drug: Pemetrexed, Drug: Cetuximab, Drug: Carboplatin, Drug: CisplatinCycle 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologic or cytologic diagnosis of squamous cell head and neck cancer (HNC)
- Prior therapies:
- An estimated life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Biological tissue available for biomarker analysis on tumor tissue.
Key exclusion criteria (15 listed)
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Are receiving concurrent chronic systemic immune therapy, or chemotherapy for a disease other than cancer.
- Concurrent administration of any other antitumor therapy.
- Known prior allergic/hypersensitivity reaction to any of the components of the study treatment.
- Serious concomitant systemic disorder (for example, active infection) or psychiatric disorder that, in the opinion of the investigator, would compromise the participant's ability to complete the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemetrexedAlso: Alimta, LY231514Administered intravenously, for maximum of 6 cycles. | Drug | Triplet Combination Therapy |
| CetuximabAlso: ErbituxAdministered 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. | Drug | Triplet Combination Therapy |
| CarboplatinAdministered intravenously, for a maximum of 6 cycles | Drug | Triplet Combination Therapy |
| CisplatinAdministered intravenously, for a maximum of 6 cycles | Drug | Triplet Combination Therapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)
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.
4 secondary outcomes
Overall Survival (OS)
Time frame: From enrollment to the date of death from any cause up to 26.4 months (assessment completed during trial period at least every 3 months)
Percentage of Participants Having a Confirmed Partial Response (PR) or Complete Response (CR)
Time frame: From enrollment to objectively determined progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment until progressive disease)
Change From Baseline in Participant-Reported European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
Time frame: Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
Change From Baseline in Performance Status Scale for Head and Neck Cancer (PSS-HNC)
Time frame: Baseline, Day 1 of Cycles 2, 4, 6, cetuximab monotherapy Cycles 2 and 4 (21-day cycle)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemetrexed, Cetuximab and Carboplatin in people with Head and Neck Neoplasms, run by Eli Lilly and Company at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From enrollment to measured progressive disease up to 15.3 months (tumor assessments performed every other cycle during study treatment, and then every 6 weeks during follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.