Trial · NCT02369458
Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies
NCT02369458, Phase 2, Completed, Washington University School of Medicine; results first posted 2023-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies. Trials, record NCT02369458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02369458
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies
- NCT number
- NCT02369458
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Squamous Cell Carcinoma of the Head and Neck, Squamous Cell Carcinoma, Head and Neck
- Interventions
- Mitomycin-C, Pegfilgrastim
- First posted
- 2015-02-24
- Last updated
- 2025-11-18
- Results first posted
- 2023-05-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response Rate (TRR) | Approximately 6 months (median 5.6 months with full range of 0.1-33.7 months) | * TRR will be evaluated separately in p16- (HPV-unrelated) HNSCC patients and in p16+ (HPV positive) OPSCC patients using two optimal two-stage Simon designs. In both cases, the expected TRR is 10%. A TRR of 30% is considered a clinically significant increase. * RECIST 1.1 will be used for this outcome. |
| Primary | Tumor Response Rate (TRR) for Participants Enrolled Post October 2020 | Approximately 6 months (median 4.0 months with full range of 0.5-12.0 months) | * TRR will be evaluated in p16+ (HPV positive) OPSCC HNSCC patients * RECIST 1.1 will be used for this outcome. |
| Secondary | Progression-free Survival (PFS) | Approximately 6 months (median 5.6 months with full range of 0.1-33.7 months) | * PFS is defined as the duration of time from start of treatment to time of first radiologic confirmation of progression or death, whichever occurs first. * Progressive disease per RECIST 1.1 * Target lesions - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. * Non-target lesions - Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. |
| Secondary | Number of Participants With Grade 3/4/5 Adverse Events | 28 days after completion of treatment (median length of follow-up was 96 days, full range of 3-463 days) | -Using CTCAE Version 3.0 |
| Secondary | Overall Survival (OS) | Through completion of follow-up (median length of follow-up Cohort A= 6.6 months IQR 2.7-12.0 months, median length of follow-up Cohort B=3.2 months IQR 1.5-9.4 months) | -Defined as the date of first treatment to the date of death, last date alive, or date of patient withdrawal. |
| Other | Quality of Life as Measured by the EORTC QLQ-C30 | Baseline, every 5 weeks, and end of treatment (estimated at 6 months) | -EORTC QLQ-C30: this has a total score, one general QOL, and one "within the last week" subscale, as well as a general health item and a single overall QOL item. This study does not use current empirical guidelines for the EORTC-QLQ-30 global score with the understanding that both the magnitude and variance of scores vary considerably from patient to patient, from one time point to another and by such factors as disease condition, age, and comorbidity. The participants can choose from 1-4 with 1 being Not At All and 4 being Very Much. |
| Other | Quality of Life as Measured by the Cognitive Failures Questions (CFQ) | Baseline, every 5 weeks, and end of treatment (estimated at 6 months) | -Cognitive Failures Questions (CFQ) - has 3 subscales describing perception, memory, and motor function. A change in 1 standard deviation will be considered a perceptible difference. The participants can choose a scale from 0-4 with 0 being Never and 4 being Very Often. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tumor Response Rate (TRR) | Approximately 6 months (median 5.6 months with full range of 0.1-33.7 months) | One participant in each arm were not evaluable for tumor response rate. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Tumor Response Rate (TRR) for Participants Enrolled Post October 2020 | Approximately 6 months (median 4.0 months with full range of 0.5-12.0 months) | Only participants enrolled post October 2020 are evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | Approximately 6 months (median 5.6 months with full range of 0.1-33.7 months) | One participant in each arm were not evaluable for this outcome measure. | months | MEDIAN |
| SECONDARY | Number of Participants With Grade 3/4/5 Adverse Events | 28 days after completion of treatment (median length of follow-up was 96 days, full range of 3-463 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival (OS) | Through completion of follow-up (median length of follow-up Cohort A= 6.6 months IQR 2.7-12.0 months, median length of follow-up Cohort B=3.2 months IQR 1.5-9.4 months) | months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Quality of Life as Measured by the EORTC QLQ-C30 | Baseline, every 5 weeks, and end of treatment (estimated at 6 months) | |||
| OTHER_PRE_SPECIFIED | Quality of Life as Measured by the Cognitive Failures Questions (CFQ) | Baseline, every 5 weeks, and end of treatment (estimated at 6 months) |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tumor Response Rate (TRR) | Cohort A: p16+ OPSCC | 3 | Participants | ||
| Tumor Response Rate (TRR) | Cohort B: p16- HNSCC | 0 | Participants | ||
| Tumor Response Rate (TRR) for Participants Enrolled Post October 2020 | Cohort A: p16+ OPSCC | 0 | Participants | ||
| Progression-free Survival (PFS) | Cohort A: p16+ OPSCC | 2.2 | 95% Confidence Interval 1.6 to 3.4 | months | |
| Progression-free Survival (PFS) | Cohort B: p16- HNSCC | 2.1 | 95% Confidence Interval 1.0 to 3.0 | months | |
| Number of Participants With Grade 3/4/5 Adverse Events | Cohort A: p16+ OPSCC and Cohort B: p16- OPSCC | 26 | Participants | ||
| Overall Survival (OS) | Cohort A: p16+ OPSCC | 6.6 | 95% Confidence Interval 3.5 to 9.9 | months | |
| Overall Survival (OS) | Cohort B: p16- HNSCC | 3.2 | 95% Confidence Interval 1.5 to 9.4 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: p16+ OPSCC | 35 | |
| Overall Study | STARTED | Cohort B: p16- HNSCC | 13 | |
| Overall Study | COMPLETED | Cohort A: p16+ OPSCC | 34 | |
| Overall Study | COMPLETED | Cohort B: p16- HNSCC | 13 | |
| Overall Study | NOT COMPLETED | Cohort A: p16+ OPSCC | 1 | |
| Overall Study | NOT COMPLETED | Cohort B: p16- HNSCC | 0 |
Source ClinicalTrials.gov
Adverse events129
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 | Anemia | Blood and lymphatic system disorders | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 45 | 47 | |
| other | Atrial fibrillation | Cardiac disorders | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 1 | 47 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 1 | 47 | |
| other | Ear popping | Ear and labyrinth disorders | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 1 | 47 | |
| other | Hearing loss (no program) | Ear and labyrinth disorders | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 3 | 47 | |
| other | Tinnitus | Ear and labyrinth disorders | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 3 | 47 | |
| other | Diabetes | Endocrine disorders | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 3 | 47 | |
| other | Hypothyroidism | Endocrine disorders | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 2 | 47 | |
| other | Glaucoma | Eye disorders | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 1 | 47 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 3 | 47 |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 47 | 47 |
| Total, other adverse events | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 47 | 47 |
| Total, serious adverse events | Cohort A: p16+ OPSCC and Cohort B: p16- HNSCC | 21 | 47 |
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 |
|---|
| Cohort A: p16+ OPSCC vs Cohort B: p16- HNSCC: Tumor Response Rate (TRR) |
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/NCT02369458
GET https://conductscience.org/api/trials/v1/NCT02369458/events?page=2