Trial · NCT00280150
Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer
NCT00280150, Phase 1, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2017-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer. Trials, record NCT00280150. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00280150
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer
- NCT number
- NCT00280150
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Lung Cancer
- Interventions
- bevacizumab, carboplatin, erlotinib hydrochloride, paclitaxel, 3-dimensional conformal radiation therapy
- First posted
- 2006-01-20
- Last updated
- 2017-06-19
- Results first posted
- 2017-06-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008]) | 6 weeks after completion of therapy | Dose-limiting toxicities (DLTs) were used to establish which cohort would be used for the phase II portion of the trial. DLTs were defined as any grade 3 or 4 nonhematologic toxicity with the exception of esophagitis, which had to be grade 4; grade 4 neutropenia lasting greater than or equal to 7 days and thrombocytopenia to less than 20,000/microliter. |
| Primary | Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | 6 weeks after completion of therapy | A list of Hematologic and nonhematologic toxicities associated with induction and concurrent therapy. This includes the percentage of patients who experienced grades 2-4 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). |
| Secondary | Progression-free Survival (PFS) | 5 years | The length of time during and after the treatment of a stage IIIA/B NSCLC that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II) | 5 years | Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement. The same method of assessment and the same techniques should be used to characterize each identified and reported lesion at baseline and during follow-up. Complete Response (CR)- Disappearance of all target lesions |
| Secondary | Overall Response Rate and Survival Profile | 5 years | The overall response rate (ORR) to the two cycles of induction therapy plus bevacizumab in stage IIIA/B NSCLC. ORR is the portion of patients with a tumor size reduction for a minimum time period. Response duration is measured from the time of initial response until documented tumor progression. |
| Secondary | Feasibility and Tolerability of Administering Consolidation Therapy | 6 cycles | The proportion of patients who were able to complete consolidation therapy after induction therapy and chemoradiotherapy |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008]) | 6 weeks after completion of therapy | This was a phase I objective only, so the phase II participants are not included. | DLTs | NUMBER |
| PRIMARY | Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | 6 weeks after completion of therapy | Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable for toxicity. 42 patients were eligible for concurrent therapy. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | 5 years | Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients. | Months | MEDIAN |
| SECONDARY | Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II) | 5 years | 43 of 45 patients received both cycles of induction C/P therapy plus bevacizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate and Survival Profile | 5 years | Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients. | percentage of participants | NUMBER |
| SECONDARY | Feasibility and Tolerability of Administering Consolidation Therapy | 6 cycles | Of the initial 14 patients, only 9 (64%) patients were able to start consolidation therapy and only 5 (36%) patients were able to complete 6 cycles. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008]) | Cohort 1 | 0 | DLTs | ||
| Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008]) | Cohort 2 | 0 | DLTs | ||
| Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008]) | Cohort 3 | 2 | DLTs | ||
| Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | Induction Therapy | Anemia | 4 | percentage of participants | |
| Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | Concurrent Therapy | Anemia | 17 | percentage of participants | |
| Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | Induction Therapy | Neutrophenia | 52 | percentage of participants | |
| Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | Concurrent Therapy | Neutrophenia | 35 | percentage of participants | |
| Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | Induction Therapy | Thrombocytopenia | 0 | percentage of participants | |
| Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | Concurrent Therapy | Thrombocytopenia | 16 | percentage of participants | |
| Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | Induction Therapy | Febrile neutropenia | 0 | percentage of participants |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 5 | |
| Overall Study | STARTED | Cohort 2 | 5 | |
| Overall Study | STARTED | Cohort 3 | 6 | |
| Overall Study | STARTED | Phase II | 30 | |
| Overall Study | Cohort Induction | Cohort 1 | 5 | |
| Overall Study | Cohort Induction | Cohort 2 | 5 | |
| Overall Study | Cohort Induction | Cohort 3 | 6 | |
| Overall Study | Cohort Induction | Phase II | 30 | |
| Overall Study | Consolidation Therapy | Cohort 1 | 2 | |
| Overall Study | Consolidation Therapy | Cohort 2 | 5 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events138
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 | Alkaline phosphatase | Investigations | Overall Study | 2 | 45 | |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Overall Study | 6 | 45 | |
| other | Neutrophils/granulocytes (ANC/AGC) | Investigations | Overall Study | 1 | 45 | |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Respiratory, thoracic and mediastinal disorders | Overall Study | 2 | 45 | |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Overall Study | 2 | 45 | |
| other | Anorexia | Metabolism and nutrition disorders | Overall Study | 12 | 45 | |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Overall Study | 1 | 45 | |
| other | Bilirubin (hyperbilirubinemia) | Investigations | Overall Study | 1 | 45 | |
| other | Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Injury, poisoning and procedural complications | Overall Study | 3 | 45 | |
| other | Burn | Injury, poisoning and procedural complications | Overall Study | 1 | 45 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall Study | 30 | 45 |
| Total, other adverse events | Overall Study | 45 | 45 |
| Total, serious adverse events | Overall Study | 19 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23045594 | 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/NCT00280150
GET https://conductscience.org/api/trials/v1/NCT00280150/results?page=2