Trial · NCT00461708
A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
NCT00461708, Phase 2, Completed, Hoffmann-La Roche; results first posted 2015-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival. Trials, record NCT00461708. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00461708
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tarceva (Erlotinib) in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas: Relationship Between Skin Toxicity and Survival
- NCT number
- NCT00461708
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 153 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Pancreatic Cancer
- Interventions
- Erlotinib, Gemcitabine
- First posted
- 2007-04-18
- Last updated
- 2015-10-15
- Results first posted
- 2015-10-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Died During the Study | Enrollment through Cycle 24 (4-week cycles), up to 24 months. | |
| Primary | Overall Survival (OS) During the Study | Enrollment through Cycle 24 (4-week cycles), up to 24 months. | OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology. |
| Secondary | Number of Participants Who Died at 6 Months | Enrollment through Cycle 6 (4-week cycles), up to 6 months. | |
| Secondary | OS At 6 Months | Enrollment through Cycle 6 (4-week cycles), up to 6 months. | OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology. |
| Secondary | Number of Participants Who Died During the Study By Rash Grade | Enrollment through Cycle 24 (4-week cycles), up to 24 months. | |
| Secondary | OS By Rash Grade | Enrollment through Cycle 24 (4-week cycles), up to 24 months. | OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology. |
| Secondary | Number of Participants With Disease Progression or Death | Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months. | Progression-free survival (PFS) was defined as the time from the date of enrollment to the date of document disease progression or death due to any cause. As per Response Evaluation Criteria in Solid Tumors (RECIST) V 1.0, progressive disease (PD) was defined for target lesions (TLs) as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded since the start of treatment, and for non-target lesions (NTLs) as unequivocal progression of NTLs. Participants whose last recorded status was not PD or death were censored. |
| Secondary | PFS | Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months | The time, in months, from enrollment to PFS event. Participants whose last recorded status was not progression or death were censored. PFS was estimated using Kaplan-Meier methodology. |
| Secondary | Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST | Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months. | As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR. |
| Secondary | Percentage of Participants With Disease Control According to RECIST | Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months. | Disease control was defined as BOR of CR, PR, or stable disease (SD). As per RECIST V 1.0: for TLs, a CR was defined as the disappearance of all TLs; and a PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, a CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits. Participants for whom no assessment of response was available and who had finalized the study due to disease progression or tumor-related death, disease progression was considered the BOR. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Died During the Study | Enrollment through Cycle 24 (4-week cycles), up to 24 months. | ITT population | participants | NUMBER |
| PRIMARY | Overall Survival (OS) During the Study | Enrollment through Cycle 24 (4-week cycles), up to 24 months. | ITT population; only participants who died were included in the analysis. | months | MEDIAN |
| SECONDARY | Number of Participants Who Died at 6 Months | Enrollment through Cycle 6 (4-week cycles), up to 6 months. | ITT population | participants | NUMBER |
| SECONDARY | OS At 6 Months | Enrollment through Cycle 6 (4-week cycles), up to 6 months. | ITT population; only participants who died were included in the analysis. | months | MEDIAN |
| SECONDARY | Number of Participants Who Died During the Study By Rash Grade | Enrollment through Cycle 24 (4-week cycles), up to 24 months. | ITT population | participants | NUMBER |
| SECONDARY | OS By Rash Grade | Enrollment through Cycle 24 (4-week cycles), up to 24 months. | ITT population; only participants who died were included in the analysis. | months | MEDIAN |
| SECONDARY | Number of Participants With Disease Progression or Death | Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months. | ITT population | participants | NUMBER |
| SECONDARY | PFS | Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months | ITT population; only participants with an event (death or disease progression) were included in the analysis. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST | Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months. | ITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control According to RECIST | Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months. | ITT population | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Died During the Study | Erlotinib, Gemcitabine: Rash Grade < 2 | 102 | participants | ||
| Number of Participants Who Died During the Study | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 27 | participants | ||
| Overall Survival (OS) During the Study | Erlotinib, Gemcitabine: Rash Grade < 2 | 4.468 | 95% Confidence Interval 3.618 to 5.318 | months | |
| Overall Survival (OS) During the Study | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 10.546 | 95% Confidence Interval 9.679 to 11.414 | months | |
| Number of Participants Who Died at 6 Months | Erlotinib, Gemcitabine: Rash Grade < 2 | 69 | participants | ||
| Number of Participants Who Died at 6 Months | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 8 | participants | ||
| OS At 6 Months | Erlotinib, Gemcitabine: Rash Grade < 2 | 4.468 | 95% Confidence Interval 3.618 to 5.318 | months | |
| OS At 6 Months | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | NA | 95% Confidence Interval NA to NA | months | |
| Number of Participants Who Died During the Study By Rash Grade | Erlotinib, Gemcitabine: Rash Grade 0 | 65 | participants | ||
| Number of Participants Who Died During the Study By Rash Grade | Erlotinib, Gemcitabine: Rash Grade 1 | 37 | participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2 | 115 | |
| Overall Study | STARTED | Erlotinib, Gemcitabine: Rash Grade Greater Than/Equal to (≥) 2 | 38 | |
| Overall Study | COMPLETED | Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2 | 0 | |
| Overall Study | COMPLETED | Erlotinib, Gemcitabine: Rash Grade Greater Than/Equal to (≥) 2 | 0 | |
| Overall Study | NOT COMPLETED | Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2 | 115 | |
| Overall Study | NOT COMPLETED | Erlotinib, Gemcitabine: Rash Grade Greater Than/Equal to (≥) 2 | 38 |
Source ClinicalTrials.gov
Adverse events404
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 | Nausea | Gastrointestinal disorders | Erlotinib, Gemcitabine: Rash Grade < 2 | 43 | 115 | |
| other | Nausea | Gastrointestinal disorders | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 12 | 38 | |
| other | Constipation | Gastrointestinal disorders | Erlotinib, Gemcitabine: Rash Grade < 2 | 38 | 115 | |
| other | Constipation | Gastrointestinal disorders | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 12 | 38 | |
| other | Vomiting | Gastrointestinal disorders | Erlotinib, Gemcitabine: Rash Grade < 2 | 34 | 115 | |
| other | Vomiting | Gastrointestinal disorders | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 8 | 38 | |
| other | Neutropenia | Blood and lymphatic system disorders | Erlotinib, Gemcitabine: Rash Grade < 2 | 20 | 115 | |
| other | Neutropenia | Blood and lymphatic system disorders | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 16 | 38 | |
| other | Anorexia | Metabolism and nutrition disorders | Erlotinib, Gemcitabine: Rash Grade < 2 | 62 | 115 | |
| other | Anorexia | Metabolism and nutrition disorders | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 11 | 38 |
1 to 10 of 404Source ClinicalTrials.gov
See all 404 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erlotinib, Gemcitabine: Rash Grade < 2 | ||
| Total, all-cause mortality | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | ||
| Total, other adverse events | Erlotinib, Gemcitabine: Rash Grade < 2 | 115 | 115 |
| Total, other adverse events | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 38 | 38 |
| Total, serious adverse events | Erlotinib, Gemcitabine: Rash Grade < 2 | 58 | 115 |
| Total, serious adverse events | Erlotinib, Gemcitabine: Rash Grade ≥ 2 | 14 | 38 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Erlotinib, Gemcitabine: Rash Grade < 2 vs Erlotinib, Gemcitabine: Rash Grade ≥ 2: Number of Participants Who Died at 6 Months | Trial comparisons |
| Erlotinib, Gemcitabine: Rash Grade < 2 vs Erlotinib, Gemcitabine: Rash Grade ≥ 2: Number of Participants With Disease Progression or Death | Trial comparisons |
| Erlotinib, Gemcitabine: Rash Grade < 2 vs Erlotinib, Gemcitabine: Rash Grade ≥ 2: Number of Participants Who Died During the Study | Trial comparisons |
| Erlotinib, Gemcitabine: Rash Grade < 2 vs Erlotinib, Gemcitabine: Rash Grade ≥ 2: serious adverse events | 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/NCT00461708
GET https://conductscience.org/api/trials/v1/NCT00461708/results?page=2