Trial · NCT00652366
A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
NCT00652366, Phase 2, Completed, Hoffmann-La Roche; results first posted 2015-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer. Trials, record NCT00652366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00652366
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-Escalation to Rash Study of Tarceva (Erlotinib) Plus Gemcitabine in Patients With Metastatic Pancreatic Cancer
- NCT number
- NCT00652366
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 467 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Pancreatic Cancer
- Interventions
- Erlotinib, escalating dose, Erlotinib, standard dose, Gemcitabine
- First posted
- 2008-04-03
- Last updated
- 2015-02-11
- Results first posted
- 2015-02-11
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Died Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | Overall survival (OS) assessed from the point of randomization was defined as the time from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. |
| Primary | OS Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | OS assessed from the point of randomization was defined as the median time, in months, from randomization to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. The 95 percent (%) confidence interval (CI) was determined using Kaplan-Meier methodology. |
| Secondary | Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | Progression-free survival (PFS) as assessed from the point of randomization was defined as the time from randomization to the first occurrence of progressive disease (PD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause. For target lesions (TLs), PD was defined as at least a 20% increase in the sum of longest diameter (SLD) of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. |
| Secondary | PFS Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | PFS assessed from the point of randomization was defined as the median time, in weeks, from randomization to disease progression or death due to any cause. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. The 95% CI was determined using Kaplan-Meier methodology. |
| Secondary | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months. | BOR was defined as a confirmed CR or PR for at least 4 weeks. CR was defined as the disappearance of all TLs. PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. The 95% CI for one sample binomial was determined using Pearson-Clopper method. |
| Secondary | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months. | CR was defined as the disappearance of all TLs. 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. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Secondary | Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months. | Disease control was defined as a participant with a response of CR or PR for at least 4 weeks at any time during treatment, or SD that was maintained for at least 8 weeks after the start of treatment. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Secondary | Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In | BL and weekly thereafter for up to 46 months. | OS assessed from the start of the 4-week run in period was defined as the time from BL to the date of death due to any cause. Participants still alive at the time of analysis were censored at the date they were last known to be alive. |
| Secondary | OS Assessed From Start of 4-Week Run-In | BL and weekly thereafter for up to 46 months. | OS assessed from the start of the 4-week run in period was defined as the median time, in months, from BL to the date of death, due to any cause. Participants who were still alive at the time of analysis were censored at the date they were last known to be alive. The 95% CI was determined using Kaplan-Meier methodology. |
| Secondary | Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months. | PFS as assessed from the start of 4-week run-in was defined as the time from BL to the first occurrence of PD according to RECIST or death due to any cause. For TLs, PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, PD was defined as unequivocal progression of existing NTLs. Participants who had neither progressed nor died at time of analysis were censored at the date of last tumor assessment. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Died Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | Full analysis set (FAS): all randomized participants. | percentage of participants | NUMBER |
| PRIMARY | OS Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | FAS | months | MEDIAN |
| SECONDARY | Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | FAS | percentage of participants | NUMBER |
| SECONDARY | PFS Assessed From Point of Randomization | Randomization [Day 1 of Cycle 2 (4-week cycles)] and weekly thereafter for up to 46 months. | FAS | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months. | FAS | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months. | FAS | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With SD (Maintained for at Least 8 Weeks) or CR or PR (Maintained for at Least 4 Weeks) According to RECIST | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression for up to 46 months. | FAS | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died as Assessed From Start of 4-Week Run-In | BL and weekly thereafter for up to 46 months. | FAS | percentage of participants | NUMBER |
| SECONDARY | OS Assessed From Start of 4-Week Run-In | BL and weekly thereafter for up to 46 months. | FAS | months | MEDIAN |
| SECONDARY | Percentage of Participants With Disease Progression or Death as Assessed From the Start of 4-Week Run-In | BL, Weeks 8, 16, 24, 32, 40, every 12 weeks thereafter until disease progression or death for up to 46 months. | FAS | percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Died Assessed From Point of Randomization | G+E Standard Dose: Rash Grade < 2 | 81.3 | percentage of participants | ||
| Percentage of Participants Who Died Assessed From Point of Randomization | G+E Escalating Dose: Rash Grade < 2 | 85.7 | percentage of participants | ||
| OS Assessed From Point of Randomization | G+E Standard Dose: Rash Grade < 2 | 8.4 | 95% Confidence Interval 6.4 to 10.0 | months | |
| OS Assessed From Point of Randomization | G+E Escalating Dose: Rash Grade < 2 | 7.0 | 95% Confidence Interval 5.8 to 8.3 | months | |
| Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization | G+E Standard Dose: Rash Grade < 2 | 90.7 | percentage of participants | ||
| Percentage of Participants With Disease Progression or Death as Assessed From Point of Randomization | G+E Escalating Dose: Rash Grade < 2 | 88.6 | percentage of participants | ||
| PFS Assessed From Point of Randomization | G+E Standard Dose: Rash Grade < 2 | 19.4 | 95% Confidence Interval 16.0 to 26.9 | weeks | |
| PFS Assessed From Point of Randomization | G+E Escalating Dose: Rash Grade < 2 | 15.3 | 95% Confidence Interval 11.3 to 19.1 | weeks | |
| Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST | G+E Standard Dose: Rash Grade < 2 | 14.7 | 95% Confidence Interval 7.6 to 24.7 | percentage of participants | |
| Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST | G+E Escalating Dose: Rash Grade < 2 | 8.6 | 95% Confidence Interval 3.2 to 17.7 | percentage of participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gemcitabine (G) Plus (+) Erlotinib (E): Rash ≥ Grade 2 | 106 | |
| Overall Study | STARTED | G+E Standard Dose: Rash Grade Less Than (<) 2 | 75 | |
| Overall Study | STARTED | G+E Escalating Dose: Rash Grade < 2 | 71 | |
| Overall Study | STARTED | G+E: No Rash Non-Eligibl | 179 | |
| Overall Study | STARTED | G+E: Early Drop Out | 36 | |
| Overall Study | COMPLETED | Gemcitabine (G) Plus (+) Erlotinib (E): Rash ≥ Grade 2 | 0 | |
| Overall Study | COMPLETED | G+E Standard Dose: Rash Grade Less Than (<) 2 | 0 | |
| Overall Study | COMPLETED | G+E Escalating Dose: Rash Grade < 2 | 0 | |
| Overall Study | COMPLETED | G+E: No Rash Non-Eligibl | 0 | |
| Overall Study | COMPLETED | G+E: Early Drop Out | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events900
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 | Diarrhoea | Gastrointestinal disorders | G+E: Rash ≥ Grade 2 | 49 | 105 | |
| other | Diarrhoea | Gastrointestinal disorders | G+E Standard Dose: Rash Grade < 2 | 33 | 77 | |
| other | Diarrhoea | Gastrointestinal disorders | G+E Escalating Dose: Rash Grade < 2 | 35 | 71 | |
| other | Diarrhoea | Gastrointestinal disorders | G+E: No Rash Non-Eligible | 71 | 178 | |
| other | Diarrhoea | Gastrointestinal disorders | G+E: Early Drop Out | 9 | 36 | |
| other | Nausea | Gastrointestinal disorders | G+E: Rash ≥ Grade 2 | 50 | 105 | |
| other | Nausea | Gastrointestinal disorders | G+E Standard Dose: Rash Grade < 2 | 28 | 77 | |
| other | Nausea | Gastrointestinal disorders | G+E Escalating Dose: Rash Grade < 2 | 24 | 71 | |
| other | Nausea | Gastrointestinal disorders | G+E: No Rash Non-Eligible | 69 | 178 | |
| other | Nausea | Gastrointestinal disorders | G+E: Early Drop Out | 9 | 36 |
1 to 10 of 900Source ClinicalTrials.gov
See all 900 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | G+E: Rash ≥ Grade 2 | ||
| Total, all-cause mortality | G+E Standard Dose: Rash Grade < 2 | ||
| Total, all-cause mortality | G+E Escalating Dose: Rash Grade < 2 | ||
| Total, all-cause mortality | G+E: No Rash Non-Eligible | ||
| Total, all-cause mortality | G+E: Early Drop Out | ||
| Total, other adverse events | G+E: Rash ≥ Grade 2 | 105 | 105 |
| Total, other adverse events | G+E Standard Dose: Rash Grade < 2 | 74 | 77 |
| Total, other adverse events | G+E Escalating Dose: Rash Grade < 2 | 71 | 71 |
| Total, other adverse events | G+E: No Rash Non-Eligible | 178 | 178 |
| Total, other adverse events | G+E: Early Drop Out | 34 | 36 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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/NCT00652366
GET https://conductscience.org/api/trials/v1/NCT00652366/results?page=2