Trial · NCT00054691
ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
NCT00054691, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2015-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin. Trials, record NCT00054691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00054691
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ZD1839 (Iressa) for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
- NCT number
- NCT00054691
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Skin Cancer
- Interventions
- Iressa
- First posted
- 2003-02-07
- Last updated
- 2015-03-13
- Results first posted
- 2015-02-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease) | Every 8 weeks till disease progression. | Responses were assessed according to the Union Internationale Contre le Cancer (UICC) / World Health Organization (WHO) criteria. Objective response (measurable response) defined as: Partial response (PR): Applies only to participants with at least 1 measurable lesion; \>/=50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. Stable Disease (SD): No progression of evaluable disease and/or no new lesions. Progressive Disease (PD): 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease. |
| Secondary | Duration of Response | Every 8 weeks till disease progression. | Response duration was defined as the time from initial response during therapy to progression of 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 | Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease) | Every 8 weeks till disease progression. | Out of 40 participants, 2 participants had unmeasurable disease and 1 participant was noncompliant. | participants | NUMBER |
| SECONDARY | Duration of Response | Every 8 weeks till disease progression. | Out of 40 participants, 19 participants had progressive disease, 2 participants had unmeasurable disease and 1 participant was noncompliant. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease) | Iressa (ZD1839) | Stable Disease | 14 | participants | |
| Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease) | Iressa (ZD1839) | Partial Response | 4 | participants | |
| Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease) | Iressa (ZD1839) | Progressive Disease | 19 | participants | |
| Duration of Response | Iressa (ZD1839) | 24.8 | Full Range 0.9 to 47.2 | months |
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 | Iressa (ZD1839) | 40 | |
| Overall Study | COMPLETED | Iressa (ZD1839) | 37 | |
| Overall Study | NOT COMPLETED | Iressa (ZD1839) | 3 |
Source ClinicalTrials.gov
Adverse events83
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 | ACNE | Skin and subcutaneous tissue disorders | Iressa (ZD1839) | 3 | 40 | 3 |
| other | ALLERGIC RHINITIS | General disorders | Iressa (ZD1839) | 1 | 40 | 1 |
| other | ALOPECIA | Skin and subcutaneous tissue disorders | Iressa (ZD1839) | 2 | 40 | 2 |
| other | ALT, SGPT | Hepatobiliary disorders | Iressa (ZD1839) | 1 | 40 | 1 |
| other | ANEMIA | Blood and lymphatic system disorders | Iressa (ZD1839) | 1 | 40 | 1 |
| other | ANOREXIA | Psychiatric disorders | Iressa (ZD1839) | 5 | 40 | 5 |
| other | AST, SGOT | Hepatobiliary disorders | Iressa (ZD1839) | 2 | 40 | 2 |
| other | BUN INCREASE | Hepatobiliary disorders | Iressa (ZD1839) | 3 | 40 | 3 |
| other | CHEILITIS | Immune system disorders | Iressa (ZD1839) | 2 | 40 | 2 |
| other | CONSTIPATION | Gastrointestinal disorders | Iressa (ZD1839) | 1 | 40 | 1 |
1 to 10 of 83Source ClinicalTrials.gov
See all 83 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Iressa (ZD1839) | ||
| Total, other adverse events | Iressa (ZD1839) | 40 | 40 |
| Total, serious adverse events | Iressa (ZD1839) | 17 | 40 |
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 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/NCT00054691
GET https://conductscience.org/api/trials/v1/NCT00054691/events?page=2