Trial · NCT00603915
A Study of Gemcitabine and Cisplatin/Carboplatin Plus Erlotinib in Patients With Nasopharyngeal Cancer
NCT00603915, Phase 2, Completed, University Health Network, Toronto; results first posted 2011-08-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Gemcitabine and Cisplatin/Carboplatin Plus Erlotinib in Patients With Nasopharyngeal Cancer. Trials, record NCT00603915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00603915
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Gemcitabine and Cisplatin/Carboplatin Plus Erlotinib in Patients With Nasopharyngeal Cancer
- NCT number
- NCT00603915
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- University Health Network, Toronto
- Conditions
- Nasopharyngeal Cancer
- Interventions
- Gemcitabine, Carboplatin/Cisplatin, erlotinib
- First posted
- 2008-01-29
- Last updated
- 2019-02-28
- Results first posted
- 2011-08-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival. | From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died. | From randomization to the first documented disease progression or death from any cause, whichever came first, assessed until all participants randomized to the study have progressed for died. |
| Secondary | Number of Participants With the Responses Outlined | Measured every 2 cycles until the participant is off treatment. | Complete Response (CR): disappearance of all clinical and radiological evidence of tumour. Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive Disease (PD): at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions will also constitute progressive disease. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival. | From the on-study date until the date of first documented progression or date of death from any cause any cause until all participants have progressed or died. | Months | MEAN | |
| SECONDARY | Number of Participants With the Responses Outlined | Measured every 2 cycles until the participant is off treatment. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival. | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 6.3 | 95% Confidence Interval 5.0 to 8.6 | Months | |
| Number of Participants With the Responses Outlined | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | Complete Response | 0 | Participants | |
| Number of Participants With the Responses Outlined | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | Partial Response | 7 | Participants | |
| Number of Participants With the Responses Outlined | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | Stable Disease | 11 | Participants | |
| Number of Participants With the Responses Outlined | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | Progressive Disease | 1 | Participants | |
| Number of Participants With the Responses Outlined | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | Inevaluable | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 20 | |
| Overall Study | COMPLETED | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 19 | |
| Overall Study | NOT COMPLETED | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 1 |
Source ClinicalTrials.gov
Adverse events13
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 | Hemoglobin decreased | Blood and lymphatic system disorders | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 19 | 20 | 19 |
| other | Lymphocyte Count decreased | Blood and lymphatic system disorders | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 19 | 20 | 19 |
| other | Leukocyte count decreased | Blood and lymphatic system disorders | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 18 | 20 | 19 |
| other | Fatigue | General disorders | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 17 | 20 | 17 |
| other | Neutrophil count decreased | Blood and lymphatic system disorders | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 18 | 20 | 18 |
| other | Pain | General disorders | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 16 | 20 | 16 |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 2 | 20 | 2 |
| serious | Syncope | Nervous system disorders | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 2 | 20 | 3 |
| serious | Stroke | Nervous system disorders | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 1 | 20 | 1 |
| serious | Pyrexia | General disorders | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 1 | 20 | 1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | ||
| Total, other adverse events | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 20 | 20 |
| Total, serious adverse events | GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB | 7 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21358293 | RESULT |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00603915
GET https://conductscience.org/api/trials/v1/NCT00603915/registered