Trial · NCT00415194
A Study for Patients With Head and Neck Cancer
NCT00415194, Phase 3, Completed, Eli Lilly and Company; results first posted 2011-04-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study for Patients With Head and Neck Cancer. Trials, record NCT00415194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00415194
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Patients With Head and Neck Cancer
- NCT number
- NCT00415194
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 795 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Head and Neck Neoplasms
- Interventions
- pemetrexed, cisplatin, placebo
- First posted
- 2006-12-22
- Last updated
- 2011-06-28
- Results first posted
- 2011-04-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Baseline to date of death from any cause up to 36 months | OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant's last contact prior to that cut-off date. |
| Secondary | Progression-free Survival (PFS) | baseline to measured progressive disease up to 33 months | Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy. |
| Secondary | Percent of Participants With a Tumor Response (Response Rate) | Baseline to progressive disease or discontinuation of study treatment up to 11 months | Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)\*100 |
| Secondary | Duration of Response (DoR) | time of response to progressive disease up to 24 months | DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is \>30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy. |
| Secondary | Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score | Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months | FACT-H\&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H\&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H\&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant's baseline score, or date of death from any cause. The MID for FACT H\&N Total score was a decrease of 12 points. |
| Secondary | Correlation Between Biomarkers and Treatment Effect | Baseline | Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first. 0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Baseline to date of death from any cause up to 36 months | Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | baseline to measured progressive disease up to 33 months | Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. | months | MEDIAN |
| SECONDARY | Percent of Participants With a Tumor Response (Response Rate) | Baseline to progressive disease or discontinuation of study treatment up to 11 months | Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | time of response to progressive disease up to 24 months | ITT population with a confirmed best response of complete response (CR) or partial response (PR). | Months | MEDIAN |
| SECONDARY | Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score | Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months | Intention to treat (ITT) population with at least Baseline data. | Months | MEDIAN |
| SECONDARY | Correlation Between Biomarkers and Treatment Effect | Baseline | Zero participants were analyzed because the relatively low number of samples collected would not have yielded a meaningful genomic analysis. | correlation coefficient | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Pemetrexed/Cisplatin | 7.33 | 95% Confidence Interval 6.34 to 8.38 | Months | |
| Overall Survival (OS) | Placebo/Cisplatin | 6.28 | 95% Confidence Interval 5.52 to 7.06 | Months | |
| Progression-free Survival (PFS) | Pemetrexed/Cisplatin | 3.61 | 95% Confidence Interval 3.15 to 4.07 | months | |
| Progression-free Survival (PFS) | Placebo/Cisplatin | 2.79 | 95% Confidence Interval 2.69 to 3.22 | months | |
| Percent of Participants With a Tumor Response (Response Rate) | Pemetrexed/Cisplatin | 12.1 | Percentage of participants | ||
| Percent of Participants With a Tumor Response (Response Rate) | Placebo/Cisplatin | 8.1 | Percentage of participants | ||
| Duration of Response (DoR) | Pemetrexed/Cisplatin | 5.29 | 95% Confidence Interval 4.21 to 5.98 | Months | |
| Duration of Response (DoR) | Placebo/Cisplatin | 4.37 | 95% Confidence Interval 3.58 to 6.44 | Months | |
| Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score | Pemetrexed/Cisplatin | 3.29 | 95% Confidence Interval 2.76 to 4.11 | Months | |
| Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score | Placebo/Cisplatin | 2.89 | 95% Confidence Interval 2.40 to 3.19 | Months |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pemetrexed/Cisplatin | 398 | |
| Overall Study | STARTED | Placebo/Cisplatin | 397 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Pemetrexed/Cisplatin | 392 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo/Cisplatin | 385 | |
| Overall Study | COMPLETED | Pemetrexed/Cisplatin | 70 | |
| Overall Study | COMPLETED | Placebo/Cisplatin | 55 | |
| Overall Study | NOT COMPLETED | Pemetrexed/Cisplatin | 328 | |
| Overall Study | NOT COMPLETED | Placebo/Cisplatin | 342 |
Source ClinicalTrials.gov
Adverse events492
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pemetrexed/Cisplatin | 118 | 392 | 133 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo/Cisplatin | 79 | 385 | 88 |
| other | Leukopenia | Blood and lymphatic system disorders | Pemetrexed/Cisplatin | 38 | 392 | 57 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo/Cisplatin | 24 | 385 | 35 |
| other | Neutropenia | Blood and lymphatic system disorders | Pemetrexed/Cisplatin | 67 | 392 | 105 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo/Cisplatin | 35 | 385 | 48 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pemetrexed/Cisplatin | 28 | 392 | 33 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo/Cisplatin | 17 | 385 | 22 |
| other | Constipation | Gastrointestinal disorders | Pemetrexed/Cisplatin | 56 | 392 | 63 |
| other | Constipation | Gastrointestinal disorders | Placebo/Cisplatin | 53 | 385 | 65 |
1 to 10 of 492Source ClinicalTrials.gov
See all 492 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pemetrexed/Cisplatin | ||
| Total, all-cause mortality | Placebo/Cisplatin | ||
| Total, other adverse events | Pemetrexed/Cisplatin | 343 | 392 |
| Total, other adverse events | Placebo/Cisplatin | 316 | 385 |
| Total, serious adverse events | Pemetrexed/Cisplatin | 185 | 392 |
| Total, serious adverse events | Placebo/Cisplatin | 132 | 385 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pemetrexed/Cisplatin vs Placebo/Cisplatin: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00415194
GET https://conductscience.org/api/trials/v1/NCT00415194/events?page=2