Trial · NCT00454779
PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
NCT00454779, Phase 2, Completed, Amgen; results first posted 2014-02-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response. Trials, record NCT00454779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00454779
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response
- NCT number
- NCT00454779
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 113 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
- Interventions
- Cisplatin, Panitumumab, Docetaxel, Cisplatin, Docetaxel
- First posted
- 2007-04-02
- Last updated
- 2018-10-17
- Results first posted
- 2014-02-07
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) During the First-line Treatment Phase | Every 6 weeks until disease progression or death, up to 67 months | The time from the date of randomization to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or randomization date (whichever is later) during the first-line treatment phase. |
| Secondary | Overall Response Rate (ORR) During the First-line Treatment Phase | Every 6 weeks until disease progression or death, up to 67 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population. |
| Secondary | Rate of Disease Control (RDC) During the First-line Treatment Phase | Every 6 weeks until disease progression or death, up to 67 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), \>=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after randomization. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population. |
| Secondary | Duration of Response (DOR) During the First-line Treatment Phase | Every 6 weeks until disease progression or death, up to 67 months | Calculated only for the subset of subjects who have an overall response of CR or PR while on first-line treatment phase (subsequently confirmed at least 4 weeks thereafter), and is defined as time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date. |
| Secondary | Time to Response (TTR) During the First-line Treatment Phase | Every 6 weeks until disease progression or death, up to 67 months | Time from the date of randomization to the first CR or PR during first line treatment phase (subsequently confirmed at least 4 weeks thereafter) |
| Secondary | Overall Survival (OS) for the First-line Treatment | Until death, up to 67 months | Time from the date of randomization to the date of death during the entire study |
| Secondary | Progression Free Survival (PFS) During the Second-line Treatment Phase | Every 6 weeks until disease progression or death, up to 57 months | The time from the first dose of panitumumab monotherapy to the date of first disease progression determined by the investigators per modified RECIST v1.0, or death within 60 days after the last evaluable tumor assessment or the second-line first dose date (whichever is later) during the second-line treatment phase. |
| Secondary | Overall Response Rate (ORR) During the Second-line Treatment Phase | Every 6 weeks until disease progression or death, up to 57 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Overall Response (OR) = CR + PR. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. ORR is the percentage of subjects with an overall response among the analysis population. |
| Secondary | Rate of Disease Control (RDC) During the Second-line Treatment Phase | Every 6 weeks until disease progression or death, up to 57 months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (SLD) of target lesions from baseline; Disease Progression (PD), \>=20% increase in the SLD of target lesions from nadir; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. An overall response of CR or PR must be confirmed at least 4 weeks after the criteria for response are first met. A best overall response of SD requires a visit response of SD or better no earlier than 35 days after the first dose date in second-line treatment. RCD is the percentage of subjects with a best overall response of CR, PR or SD among the analysis population. |
| Secondary | Duration of Response (DOR) During the Second-line Treatment Phase | Every 6 weeks until disease progression or death, up to 57 months | Time from the first CR or PR to the first observed disease progression by a modified RECIST v1.0. Subjects not meeting the criteria for progression by the analysis data cutoff date will be censored at their last evaluable disease assessment date. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) During the First-line Treatment Phase | Every 6 weeks until disease progression or death, up to 67 months | All randomized participants \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab) | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) During the First-line Treatment Phase | Every 6 weeks until disease progression or death, up to 67 months | all randomized subjects \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review | Percentage of Participants | MEAN |
| SECONDARY | Rate of Disease Control (RDC) During the First-line Treatment Phase | Every 6 weeks until disease progression or death, up to 67 months | all randomized subjects \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review | Percentage of Participants | MEAN |
| SECONDARY | Duration of Response (DOR) During the First-line Treatment Phase | Every 6 weeks until disease progression or death, up to 67 months | All randomized participants \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response | Months | MEDIAN |
| SECONDARY | Time to Response (TTR) During the First-line Treatment Phase | Every 6 weeks until disease progression or death, up to 67 months | All randomized participants \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab), with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response | Weeks | MEAN |
| SECONDARY | Overall Survival (OS) for the First-line Treatment | Until death, up to 67 months | All randomized participants \< 70 years of age who provide informed consent and receive at least one dose of first-line treatment (chemotherapy and/or panitumumab) | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) During the Second-line Treatment Phase | Every 6 weeks until disease progression or death, up to 57 months | Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) During the Second-line Treatment Phase | Every 6 weeks until disease progression or death, up to 57 months | Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy | Percentage of Participants | MEAN |
| SECONDARY | Rate of Disease Control (RDC) During the Second-line Treatment Phase | Every 6 weeks until disease progression or death, up to 57 months | Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy | Percentage of Participants | MEAN |
| SECONDARY | Duration of Response (DOR) During the Second-line Treatment Phase | Every 6 weeks until disease progression or death, up to 57 months | Subjects who are randomized to docetaxel and cisplatin chemotherapy alone treatment for their first-line treatment and treated subsequently with at least 1 dose of second-line panitumumab monotherapy, with at least one uni-dimensionally measurable lesion at baseline using a modified RECIST v1.0 per investigators' review and objective response | Months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) During the First-line Treatment Phase | Panitumumab Plus Chemotherapy | 6.9 | 95% Confidence Interval 4.7 to 8.3 | Months | |
| Progression Free Survival (PFS) During the First-line Treatment Phase | Chemotherapy Alone | 5.5 | 95% Confidence Interval 4.1 to 6.8 | Months | |
| Overall Response Rate (ORR) During the First-line Treatment Phase | Panitumumab Plus Chemotherapy | 44.23 | 95% Confidence Interval 30.73 to 57.73 | Percentage of Participants | |
| Overall Response Rate (ORR) During the First-line Treatment Phase | Chemotherapy Alone | 37.25 | 95% Confidence Interval 23.99 to 50.52 | Percentage of Participants | |
| Rate of Disease Control (RDC) During the First-line Treatment Phase | Panitumumab Plus Chemotherapy | 80.77 | 95% Confidence Interval 70.06 to 91.48 | Percentage of Participants | |
| Rate of Disease Control (RDC) During the First-line Treatment Phase | Chemotherapy Alone | 72.55 | 95% Confidence Interval 60.30 to 84.80 | Percentage of Participants | |
| Duration of Response (DOR) During the First-line Treatment Phase | Panitumumab Plus Chemotherapy | 8.0 | 95% Confidence Interval 5.7 to 11.1 | Months | |
| Duration of Response (DOR) During the First-line Treatment Phase | Chemotherapy Alone | 5.1 | 95% Confidence Interval 4.4 to 7.2 | Months | |
| Time to Response (TTR) During the First-line Treatment Phase | Panitumumab Plus Chemotherapy | 8.8 | Standard Deviation 3.9 | Weeks | |
| Time to Response (TTR) During the First-line Treatment Phase | Chemotherapy Alone | 10.6 | Standard Deviation 6.1 | Weeks |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First-line Treatment Phase | STARTED | Panitumumab Plus Chemotherapy | 56 | |
| First-line Treatment Phase | STARTED | Chemotherapy Alone | 57 | |
| First-line Treatment Phase | Received Study Medication | Panitumumab Plus Chemotherapy | 56 | |
| First-line Treatment Phase | Received Study Medication | Chemotherapy Alone | 55 | |
| First-line Treatment Phase | COMPLETED | Panitumumab Plus Chemotherapy | 51 | |
| First-line Treatment Phase | COMPLETED | Chemotherapy Alone | 49 | |
| First-line Treatment Phase | NOT COMPLETED | Panitumumab Plus Chemotherapy | 5 | |
| First-line Treatment Phase | NOT COMPLETED | Chemotherapy Alone | 8 | |
| Second-line Treatment Phase | STARTED | Panitumumab Plus Chemotherapy | 0 | |
| Second-line Treatment Phase | STARTED | Chemotherapy Alone | 30 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events370
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 | Panitumumab Plus Chemotherapy | 22 | 56 | |
| other | Anaemia | Blood and lymphatic system disorders | Chemotherapy Alone | 27 | 55 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Panitumumab Plus Chemotherapy | 0 | 56 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Chemotherapy Alone | 3 | 55 | |
| other | Leukopenia | Blood and lymphatic system disorders | Panitumumab Plus Chemotherapy | 7 | 56 | |
| other | Leukopenia | Blood and lymphatic system disorders | Chemotherapy Alone | 5 | 55 | |
| other | Neutropenia | Blood and lymphatic system disorders | Panitumumab Plus Chemotherapy | 9 | 56 | |
| other | Neutropenia | Blood and lymphatic system disorders | Chemotherapy Alone | 9 | 55 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Panitumumab Plus Chemotherapy | 5 | 56 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Chemotherapy Alone | 5 | 55 |
1 to 10 of 370Source ClinicalTrials.gov
See all 370 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Panitumumab Plus Chemotherapy | ||
| Total, all-cause mortality | Chemotherapy Alone | ||
| Total, other adverse events | Panitumumab Plus Chemotherapy | 54 | 56 |
| Total, other adverse events | Chemotherapy Alone | 53 | 55 |
| Total, serious adverse events | Panitumumab Plus Chemotherapy | 34 | 56 |
| Total, serious adverse events | Chemotherapy Alone | 27 | 55 |
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 |
|---|
| Panitumumab Plus Chemotherapy vs Chemotherapy Alone: 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/NCT00454779
GET https://conductscience.org/api/trials/v1/NCT00454779/events?page=2