Trial · NCT00065182
Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
NCT00065182, Phase 2, Completed, GlaxoSmithKline; results first posted 2019-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer. Trials, record NCT00065182. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00065182
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer
- NCT number
- NCT00065182
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 399 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Lung Cancer, Non-Small Cell, Non-Small-Cell Lung Cancer
- Interventions
- Topotecan/Docetaxel combination, Docetaxel
- First posted
- 2003-07-18
- Last updated
- 2019-06-24
- Other registries' IDs
- eudract:2004-002892-17
- Results first posted
- 2019-06-24
- Limitations and caveats
- The combination group was terminated as per recommendation of IDMC based on the interim analysis results occurred on 04-November-2005. Therefore all the efficacy parameters were not analyzed.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Time of Overall Survival | Up to one year from Day -1 (randomization) | Overall survival was defined as the time from randomization to death and it occurs when all randomized participants had at least one year of follow-up past their date of randomization to treatment. |
| Secondary | Number of Participants With One-year Survival | Up to one year from Day -1 (randomization) | Number of participants with one-year survival were planned to be reported. |
| Secondary | Median Time to Progression | Up to one year from Day -1 (randomization) | Time to progression is defined as the time between randomization and the first radiologically or clinically documented evidence of progression. |
| Secondary | Response Rate | Up to one year from Day -1 (randomization) | Response rate is defined as the percentage of participants in the ITT population attaining an overall best response of complete or partial response. |
| Secondary | Response Duration | Up to one year from Day -1 (randomization) | Response duration is defined as the time from initial radiologically documented response to the first radiologically or clinically documented sign of progression. |
| Secondary | Time to Response-assessed Every 8 Weeks | Every 8 Weeks post randomization | Time to response is defined as the time between randomization and the first radiologically documented complete or partial response. |
| Secondary | Assessment of Quality of Life-assessed Every 4 Weeks | Every 4 Weeks post randomization | The effect of treatment regimens on participants-perceived disease status and well-being was assessed using Lung Cancer Symptom Scale (LCSS) that consists of 9 items addressing the time frame of past day: 6 measuring major symptoms for lung malignancies (loss of appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summation items related to total symptomatic distress, activity status and global quality of life. All items are measured by visual analogue scales (VAS) which uses 100 millimeter (mm) lines to determine the intensity of participant responses. The lowest level of symptom intensity or functional disability on the VAS is on left (none) and highest intensity is on right (as much as could be). |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 16 months | AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or it is considered to be medically significant. |
| Secondary | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Up to 16 months | Hematology parameters included hemoglobin, hematocrit, red blood cell count, white blood cell count with differential leukocyte and platelet count. Differential to include total neutrophils, bands, lymphocytes, monocytes, eosinophil, and basophils. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 1, 2, 3 or 4 hematologic toxicities have been presented. |
| Secondary | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Up to 16 months | Standard chemistry evaluation included sodium, potassium, chloride, bicarbonate, calcium, phosphorous, magnesium, blood urea nitrogen (BUN)/urea, uric acid, creatinine, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, total protein and albumin. Recording of any hematology toxicity grade was done using National Cancer Institute - Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 2.0. Higher the grade, more is the toxicity. Data for number of participants with grade 3 or 4 clinical chemical toxicities have been presented. |
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 | Median Time of Overall Survival | Up to one year from Day -1 (randomization) | Intent-to-treat (ITT) population was defined as all participants randomized to one of the two treatment regimens. | Weeks | MEDIAN |
| SECONDARY | Number of Participants With One-year Survival | Up to one year from Day -1 (randomization) | ITT population. Data was not collected for this outcome measure. | ||
| SECONDARY | Median Time to Progression | Up to one year from Day -1 (randomization) | ITT population. Data was not collected for this outcome measure. | ||
| SECONDARY | Response Rate | Up to one year from Day -1 (randomization) | ITT population. Data was not collected for this outcome measure. | ||
| SECONDARY | Response Duration | Up to one year from Day -1 (randomization) | ITT population. Data was not collected for this outcome measure. | ||
| SECONDARY | Time to Response-assessed Every 8 Weeks | Every 8 Weeks post randomization | ITT population. Data was not collected for this outcome measure. | ||
| SECONDARY | Assessment of Quality of Life-assessed Every 4 Weeks | Every 4 Weeks post randomization | ITT population. Data was not collected for this outcome measure. | ||
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 16 months | mITT Population was defined as all participants who were randomized and received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | Up to 16 months | mITT population. Only those participants available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Grade 3 or 4 Clinical Chemical Toxicities | Up to 16 months | mITT population. Only those participants available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Time of Overall Survival | IV Topotecan + IV Docetaxel | 30.7 | 95% Confidence Interval 26.1 to 35.9 | Weeks | |
| Median Time of Overall Survival | IV Docetaxel | 28.6 | 95% Confidence Interval 23.6 to 36.4 | Weeks | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | IV Topotecan + IV Docetaxel | Any AEs | 186 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | IV Docetaxel | Any AEs | 172 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | IV Topotecan + IV Docetaxel | Any SAEs | 58 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | IV Docetaxel | Any SAEs | 49 | Participants | |
| Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | IV Topotecan + IV Docetaxel | Hemoglobin, Grade 1 | 76 | Participants | |
| Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | IV Docetaxel | Hemoglobin, Grade 1 | 107 | Participants | |
| Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | IV Topotecan + IV Docetaxel | Hemoglobin, Grade 2 | 95 | Participants | |
| Number of Participants With Grade 1, 2, 3 or 4 Hematologic Toxicities | IV Docetaxel | Hemoglobin, Grade 2 | 46 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IV Topotecan + IV Docetaxel | 202 | |
| Overall Study | STARTED | IV Docetaxel | 197 | |
| Overall Study | COMPLETED | IV Topotecan + IV Docetaxel | 154 | |
| Overall Study | COMPLETED | IV Docetaxel | 160 | |
| Overall Study | NOT COMPLETED | IV Topotecan + IV Docetaxel | 48 | |
| Overall Study | NOT COMPLETED | IV Docetaxel | 37 |
Source ClinicalTrials.gov
Adverse events232
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 | Fatigue | General disorders | IV Topotecan + IV Docetaxel | 90 | 200 | |
| other | Fatigue | General disorders | IV Docetaxel | 74 | 195 | |
| other | Oedema peripheral | General disorders | IV Topotecan + IV Docetaxel | 28 | 200 | |
| other | Oedema peripheral | General disorders | IV Docetaxel | 31 | 195 | |
| other | Pyrexia | General disorders | IV Topotecan + IV Docetaxel | 31 | 200 | |
| other | Pyrexia | General disorders | IV Docetaxel | 28 | 195 | |
| other | Asthenia | General disorders | IV Topotecan + IV Docetaxel | 19 | 200 | |
| other | Asthenia | General disorders | IV Docetaxel | 21 | 195 | |
| other | Chest pain | General disorders | IV Topotecan + IV Docetaxel | 17 | 200 | |
| other | Chest pain | General disorders | IV Docetaxel | 19 | 195 |
1 to 10 of 232Source ClinicalTrials.gov
See all 232 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IV Topotecan + IV Docetaxel | 170 | 200 |
| Total, all-cause mortality | IV Docetaxel | 165 | 195 |
| Total, other adverse events | IV Topotecan + IV Docetaxel | 181 | 200 |
| Total, other adverse events | IV Docetaxel | 166 | 195 |
| Total, serious adverse events | IV Topotecan + IV Docetaxel | 58 | 200 |
| Total, serious adverse events | IV Docetaxel | 49 | 195 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IV Topotecan + IV Docetaxel vs IV Docetaxel: Number of Participants With Clinically Significant Abnormal Vital Signs Data | Trial comparisons |
| IV Topotecan + IV Docetaxel vs IV Docetaxel: deaths from any cause | Trial comparisons |
| IV Topotecan + IV Docetaxel vs IV Docetaxel: 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/NCT00065182
GET https://conductscience.org/api/trials/v1/NCT00065182/results?page=2