Trial · NCT00126581
Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
NCT00126581, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-04-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer. Trials, record NCT00126581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00126581
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer
- NCT number
- NCT00126581
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 188 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Lung Adenocarcinoma, Lung Adenosquamous Carcinoma, Malignant Pericardial Effusion, Malignant Pleural Effusion, Minimally Invasive Lung Adenocarcinoma, Stage IIIB Lung Non-Small Cell Cancer AJCC v7, Stage IV Lung Non-Small Cell Cancer AJCC v7
- Interventions
- Carboplatin, Erlotinib, Erlotinib Hydrochloride, Paclitaxel
- First posted
- 2005-08-04
- Last updated
- 2019-08-07
- Results first posted
- 2014-04-23
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 18 Weeks Progression Free Survival (PFS) Rate | At 18 weeks | The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm. The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated. |
| Secondary | Overall Response Rate | Duration of Study (up to 3 years) | The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions |
| Secondary | Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment. | Duration of study (up to 3 years) | The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death. |
| Other | Overall Survival | Time from randomization to death (up to 3 years) | Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method. |
| Other | Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status | Duration of treatment (up to 3 years) | PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure. EGFR mutations were performed at the Dana-Farber Cancer Institute using a sensitive heteroduplex method coupled with enzymatic digestion as previously reported (Janne PA, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006). All positive findings were independently verified and subjected to sequencing. The mutation analyses were blinded to the participants' clinical outcome. |
| Other | Overall Response Rate by EGFR Mutation Status | Duration of study (up to 3 years) | Response and EGFR mutation status are defined in previous outcome measures. |
| Other | Progression Free Survival With KRAS Mutation Status | Duration of study (up to 3 years) | Progression free survival is defined in previous outcome measures. GIven the small number of KRAS mutant participants, the analysis combines data from both arms. |
| Other | Overall Response Rate With KRAS Mutational Status | Duration of study (up to 3 years) | Overall response is defined in previous outcome measures. GIven the small number of KRAS mutant participants in each treatment arm, the analysis combines data from both arms. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 18 Weeks Progression Free Survival (PFS) Rate | At 18 weeks | percentage of participants | NUMBER | |
| SECONDARY | Overall Response Rate | Duration of Study (up to 3 years) | percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment. | Duration of study (up to 3 years) | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Overall Survival | Time from randomization to death (up to 3 years) | months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status | Duration of treatment (up to 3 years) | EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis. | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Overall Response Rate by EGFR Mutation Status | Duration of study (up to 3 years) | EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Progression Free Survival With KRAS Mutation Status | Duration of study (up to 3 years) | months | MEDIAN | |
| OTHER_PRE_SPECIFIED | Overall Response Rate With KRAS Mutational Status | Duration of study (up to 3 years) | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 18 Weeks Progression Free Survival (PFS) Rate | Arm A: Erlotinib | 52 | 95% Confidence Interval NA to NA | percentage of participants | |
| 18 Weeks Progression Free Survival (PFS) Rate | Arm B: Erlotinib/Carboplatin/Paclitaxel | 69 | 95% Confidence Interval NA to NA | percentage of participants | |
| Overall Response Rate | Arm A: Erlotinib | 35 | 95% Confidence Interval 24 to 46 | percentage of participants | |
| Overall Response Rate | Arm B: Erlotinib/Carboplatin/Paclitaxel | 46 | 95% Confidence Interval 36 to 56 | percentage of participants | |
| Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment. | Arm A: Erlotinib | 20 | participants | ||
| Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment. | Arm B: Erlotinib/Carboplatin/Paclitaxel | 52 | participants | ||
| Overall Survival | Arm A: Erlotinib | 24.6 | 95% Confidence Interval 18.4 to 33.8 | months | |
| Overall Survival | Arm B: Erlotinib/Carboplatin/Paclitaxel | 19.8 | 95% Confidence Interval 14.4 to 27.8 | months | |
| Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status | Arm A: Erlotinib | EGFR Mutant | 14.1 | 95% Confidence Interval 7.0 to 19.6 | months |
| Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status | Arm B: Erlotinib/Carboplatin/Paclitaxel | EGFR Mutant | 17.2 | 95% Confidence Interval 8.2 to 28.7 | months |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Erlotinib | 81 | |
| Overall Study | STARTED | Arm B: Erlotinib/Carboplatin/Paclitaxel | 100 | |
| Overall Study | COMPLETED | Arm A: Erlotinib | 68 | |
| Overall Study | COMPLETED | Arm B: Erlotinib/Carboplatin/Paclitaxel | 80 | |
| Overall Study | NOT COMPLETED | Arm A: Erlotinib | 13 | |
| Overall Study | NOT COMPLETED | Arm B: Erlotinib/Carboplatin/Paclitaxel | 20 |
Source ClinicalTrials.gov
Adverse events664
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 | Blood/Bone Marrow - Other | Blood and lymphatic system disorders | Arm A: Erlotinib | 1 | 81 | 7 |
| other | Blood/Bone Marrow - Other | Blood and lymphatic system disorders | Arm B: Erlotinib/Carboplatin/Paclitaxel | 0 | 99 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm A: Erlotinib | 1 | 81 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm B: Erlotinib/Carboplatin/Paclitaxel | 6 | 99 | 6 |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm A: Erlotinib | 19 | 81 | 89 |
| other | Hemoglobin | Blood and lymphatic system disorders | Arm B: Erlotinib/Carboplatin/Paclitaxel | 62 | 99 | 357 |
| other | Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis) | Blood and lymphatic system disorders | Arm A: Erlotinib | 0 | 81 | 0 |
| other | Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis) | Blood and lymphatic system disorders | Arm B: Erlotinib/Carboplatin/Paclitaxel | 5 | 99 | 7 |
| other | Palpitations | Cardiac disorders | Arm A: Erlotinib | 2 | 81 | 4 |
| other | Palpitations | Cardiac disorders | Arm B: Erlotinib/Carboplatin/Paclitaxel | 2 | 99 | 2 |
1 to 10 of 664Source ClinicalTrials.gov
See all 664 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Erlotinib | ||
| Total, all-cause mortality | Arm B: Erlotinib/Carboplatin/Paclitaxel | ||
| Total, other adverse events | Arm A: Erlotinib | 78 | 81 |
| Total, other adverse events | Arm B: Erlotinib/Carboplatin/Paclitaxel | 94 | 99 |
| Total, serious adverse events | Arm A: Erlotinib | 21 | 81 |
| Total, serious adverse events | Arm B: Erlotinib/Carboplatin/Paclitaxel | 39 | 99 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180821 | Alliance for Clinical Trials in Oncology Operations Center | Galanis, Evanthia; Hahn, Olwen; Kozono, David | ALLIANCE NCTN FOUNDATION | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Erlotinib vs Arm B: Erlotinib/Carboplatin/Paclitaxel: Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment. | Trial comparisons |
| Arm A: Erlotinib vs Arm B: Erlotinib/Carboplatin/Paclitaxel: 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/NCT00126581
GET https://conductscience.org/api/trials/v1/NCT00126581/events?page=2