Trial · NCT00283244
Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC
NCT00283244, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2017-04-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC. Trials, record NCT00283244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00283244
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph II Gemcitabine, Erlotinib, and Gemcitabine With Erlotinib/Elderly Patients W/ IIIB/IV NSCLC
- NCT number
- NCT00283244
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 147 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Lung Cancer
- Interventions
- erlotinib hydrochloride, gemcitabine hydrochloride
- First posted
- 2006-01-27
- Last updated
- 2017-04-24
- Results first posted
- 2017-04-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | Six months | We would consider the combination of gemcitabine plus erlotinib or single agent erlotinib to be worthy of further study if there was an increased progressed-free survival. We would use an increase to 45% progression-free survival at 6 months as significant. 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 | Six months | The best overall response (BOR) is the best response recorded from the start of the treatment until disease progression-recurrence (taking as reference for progressive disease the smallest measurement recorded since the treatment started. The response rate was defined as the percentage of patients achieving a BOR of complete response or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Overall Survival | Up to 3 years | Survival calculated from start of treatment to death from any cause for up to three years. |
| Secondary | Toxicity | After each cycle/3 weeks, up to 3 years | Assessments for treatment toxicity will be done with each cycle according to CTCAE v3. Results listed here are grade \>=3, treatment related hematologic events (all) and Grade\>=3 treatment related non hematologic events that occurred in \>=5% of patients in any arm. Adverse events (toxicities) are graded on a 5 point scale from 1 (mild) to 5 (lethal), with grades 3 and higher being severe or life threatening. |
| Secondary | Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L) | After each cycle/3 weeks | The FACT-L is the FACT-G and a lung cancer specific (LCS) subscale given at baseline, after each cycle and at end of treatment. The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent better QOL. The TOI-L sums the PWB, FWB, and LCS subscale scores. A best response for TOI-L scores is based on change from baseline and coded as: a change \>=+6 "improved", \<= -6 "worsened" and otherwise "no change". A best overall score response is coded as: Improved (2 visit resp. of "improved" a min. of 28 days apart w/ no interim "worsened") No change (not "improved;" 2 visit resp. of "no change" or "improved" a min. of 28 days apart w/ no interim "worsened") Worsened (not "improved" or "no change;" 2 consecutive "worsened") Other (none of the above) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | Six months | months | MEDIAN | |
| SECONDARY | Response Rate | Six months | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | Up to 3 years | Months | MEDIAN | |
| SECONDARY | Toxicity | After each cycle/3 weeks, up to 3 years | participants | NUMBER | |
| SECONDARY | Quality of Life (QOL)- Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Trial Outcome Index-L (TOI-L) | After each cycle/3 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Arm A (Gemcitabine) | 3.7 | 95% Confidence Interval 2.3 to 4.7 | months | |
| Progression-free Survival | Arm B (Erlotinib) | 2.8 | 95% Confidence Interval 1.4 to 3.4 | months | |
| Progression-free Survival | Arm C (Gemcitabine + Erlotinib) | 4.1 | 95% Confidence Interval 2.4 to 5 | months | |
| Response Rate | Arm A (Gemcitabine) | 7 | percentage of participants | ||
| Response Rate | Arm B (Erlotinib) | 0 | percentage of participants | ||
| Response Rate | Arm C (Gemcitabine + Erlotinib) | 21 | percentage of participants | ||
| Overall Survival | Arm A (Gemcitabine) | 6.8 | 95% Confidence Interval 4.8 to 8.5 | Months | |
| Overall Survival | Arm B (Erlotinib) | 5.8 | 95% Confidence Interval 3.0 to 8.3 | Months | |
| Overall Survival | Arm C (Gemcitabine + Erlotinib) | 5.6 | 95% Confidence Interval 3.5 to 8.4 | Months | |
| Toxicity | Arm A (Gemcitabine) | Anemia (Grade>=3; treatment related) | 1 | participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Gemcitabine) | 44 | |
| Overall Study | STARTED | Arm B (Erlotinib) | 51 | |
| Overall Study | STARTED | Arm C (Gemcitabine + Erlotinib) | 51 | |
| Overall Study | COMPLETED | Arm A (Gemcitabine) | 26 | |
| Overall Study | COMPLETED | Arm B (Erlotinib) | 0 | |
| Overall Study | COMPLETED | Arm C (Gemcitabine + Erlotinib) | 0 | |
| Overall Study | NOT COMPLETED | Arm A (Gemcitabine) | 18 | |
| Overall Study | NOT COMPLETED | Arm B (Erlotinib) | 51 | |
| Overall Study | NOT COMPLETED | Arm C (Gemcitabine + Erlotinib) | 51 |
Source ClinicalTrials.gov
Adverse events405
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 | Albumin, Serum-Low (Hypoalbuminemia) | Metabolism and nutrition disorders | Arm A (Gemcitabine) | 2 | 44 | 2 |
| other | Albumin, Serum-Low (Hypoalbuminemia) | Metabolism and nutrition disorders | Arm B (Erlotinib) | 1 | 51 | 3 |
| other | Albumin, Serum-Low (Hypoalbuminemia) | Metabolism and nutrition disorders | Arm C (Gemcitabine + Erlotinib) | 3 | 51 | 10 |
| other | Allergic Reaction/Hypersensitivity (Including Drug Fever) | Immune system disorders | Arm A (Gemcitabine) | 2 | 44 | 2 |
| other | Allergic Reaction/Hypersensitivity (Including Drug Fever) | Immune system disorders | Arm B (Erlotinib) | 1 | 51 | 1 |
| other | Allergic Reaction/Hypersensitivity (Including Drug Fever) | Immune system disorders | Arm C (Gemcitabine + Erlotinib) | 0 | 51 | 0 |
| other | Alt, Sgpt (Serum Glutamic Pyruvic Transaminase) | Investigations | Arm A (Gemcitabine) | 0 | 44 | 0 |
| other | Alt, Sgpt (Serum Glutamic Pyruvic Transaminase) | Investigations | Arm B (Erlotinib) | 0 | 51 | 0 |
| other | Alt, Sgpt (Serum Glutamic Pyruvic Transaminase) | Investigations | Arm C (Gemcitabine + Erlotinib) | 3 | 51 | 4 |
| other | Anorexia | Metabolism and nutrition disorders | Arm A (Gemcitabine) | 13 | 44 | 17 |
1 to 10 of 405Source ClinicalTrials.gov
See all 405 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Gemcitabine) | 1 | 44 |
| Total, all-cause mortality | Arm B (Erlotinib) | 3 | 51 |
| Total, all-cause mortality | Arm C (Gemcitabine + Erlotinib) | 3 | 51 |
| Total, other adverse events | Arm A (Gemcitabine) | 40 | 44 |
| Total, other adverse events | Arm B (Erlotinib) | 46 | 51 |
| Total, other adverse events | Arm C (Gemcitabine + Erlotinib) | 48 | 51 |
| Total, serious adverse events | Arm A (Gemcitabine) | 16 | 44 |
| Total, serious adverse events | Arm B (Erlotinib) | 17 | 51 |
| Total, serious adverse events | Arm C (Gemcitabine + Erlotinib) | 26 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| P30CA016086 | Cancer Center Support Grant | FERRIS, ROBERT L. | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00283244
GET https://conductscience.org/api/trials/v1/NCT00283244/results?page=2