Trial · NCT00316173
Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer
NCT00316173, Phase 2, Completed, GlaxoSmithKline; results first posted 2009-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer. Trials, record NCT00316173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00316173
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer
- NCT number
- NCT00316173
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Ovarian Cancer, Neoplasms, Ovarian
- Interventions
- topotecan, CARBOPLATIN
- First posted
- 2006-04-20
- Last updated
- 2012-11-27
- Results first posted
- 2009-11-26
- Limitations and caveats
As only 17 of 55 participants had CR/PR, the treatment was not effective. The follow up of participants for survival was thus stopped early (original plan: every 3 months for 2 years; then every 6 months for 3-5 years; then annually/until death).
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With the Indicated Response | From start of treatment to evidence of CR or PR (up to 39.3 weeks). | Overall response rate, as determined by radiologic evaluation (utilizing the World Health Organization \[WHO\] criteria and/or physical examination was measured. Complete response (CR: complete disappearance of all lesions), partial response (PR: \>50% decrease in the measurements of the largest lesions with no appearance of new lesions), stable disease (SD: no change in tumor size for at least 8 weeks) and progressive disease (PD: \>25% increase in measurements of lesions or appearance of new lesions). |
| Secondary | Time to Response | From start of treatment to evidence of PR or CR (up to 39.3 weeks) | Time to response was calculated as the time from start of treatment until first evidence of partial response (PR; \>50% decrease in the measurements of the largest lesions with no appearance of new lesions) or complete response (CR; complete disappearance of all lesions). |
| Secondary | Duration of Response | From time of PR or CR to disease progression/death (up to 56.0 weeks) | Duration of response was calculated as the time from first documented PR or CR until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was "censored". |
| Secondary | Progression-free Survival | From start of treatment to disease progression/death (up to 67.7 weeks) | Progression-free survival (PFS) was calculated as the time from the start of treatment until disease progression or death. For participants who did not have disease progression or did not die, the date on which alternative anti-cancer therapy began was used, or the date of last contact (if sooner). The word used for such participants was "censored". Although "Time to Disease Progression" was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of "PFS". As such, "PFS" was measured, not "Time to Disease Progression". |
| Secondary | Number of Participants Who Died From the Start of Treatment to Follow-up | From start of treatment to death (up to 110.4 weeks). | The number of participants who died from the start of treatment to follow-up was calculated. For participants who did not die, the date of last contact was used. The word used for such participants was "censored". |
| Secondary | The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125) | Baseline to end of study (up to 54.7 weeks). | CA-125 is a "tumor marker", found in greater concentration in tumor cells than other cells of the body. Participants were classed as responders if their CA-125 level at the end of study was 50% or less of baseline. In addition, a confirmatory sample (taken at least 28 days after the first sample) must have also been 50% or less of baseline. |
| Secondary | Time to Disease Progression | From start of treatment to disease progression/death | Although "Time to Disease Progression" was stated as an endpoint in the protocol, the definition given in the protocol (and used in the study) was that of "Progression-free Survival". As such, "Progression-free Survival" was measured, not "Time to Disease Progression". See the outcome measure entitled "Progression-free Survival" for data pertaining to time to disease progression. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Time to Response | From start of treatment to evidence of PR or CR (up to 39.3 weeks) | All participants who showed a tumor response (CR or PR). | weeks | MEDIAN |
| SECONDARY | Duration of Response | From time of PR or CR to disease progression/death (up to 56.0 weeks) | All participants who showed a tumor response (CR or PR). | weeks | MEDIAN |
| PRIMARY | Number of Participants With the Indicated Response | From start of treatment to evidence of CR or PR (up to 39.3 weeks). | Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug | participants | NUMBER |
| SECONDARY | Progression-free Survival | From start of treatment to disease progression/death (up to 67.7 weeks) | Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug | weeks | MEDIAN |
| SECONDARY | Number of Participants Who Died From the Start of Treatment to Follow-up | From start of treatment to death (up to 110.4 weeks). | Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug | participants | NUMBER |
| SECONDARY | The Number of Participants Classified as Responders in Cancer Antigen 125 (CA-125) | Baseline to end of study (up to 54.7 weeks). | Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug | participants | NUMBER |
| SECONDARY | Time to Disease Progression | From start of treatment to disease progression/death | Intent-to-Treat (ITT) Population: all participants who received at least one dose of study drug |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Response | Activity Assessment Phase | 6.57 | 95% Confidence Interval 5.86 to 12.57 | weeks | |
| Duration of Response | Activity Assessment Phase | 42.64 | 95% Confidence Interval 36.14 to 47.14 | weeks | |
| Number of Participants With the Indicated Response | Activity Assessment Phase | Complete response | 6 | participants | |
| Number of Participants With the Indicated Response | Activity Assessment Phase | Partial response | 11 | participants | |
| Number of Participants With the Indicated Response | Activity Assessment Phase | Stable disease | 20 | participants | |
| Number of Participants With the Indicated Response | Activity Assessment Phase | Progressive disease | 7 | participants | |
| Number of Participants With the Indicated Response | Activity Assessment Phase | Not evaluable | 11 | participants | |
| Progression-free Survival | Activity Assessment Phase | 44.29 | 95% Confidence Interval 36.14 to 52.14 | weeks | |
| Number of Participants Who Died From the Start of Treatment to Follow-up | Activity Assessment Phase | Died | 8 | participants | |
| Number of Participants Who Died From the Start of Treatment to Follow-up | Activity Assessment Phase | Censored | 47 | participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Run-in Phase | STARTED | Dose-finding Phase | 22 | |
| Run-in Phase | STARTED | Activity Assessment Phase | 0 | |
| Run-in Phase | COMPLETED | Dose-finding Phase | 15 | |
| Run-in Phase | COMPLETED | Activity Assessment Phase | 0 | |
| Run-in Phase | NOT COMPLETED | Dose-finding Phase | 7 | |
| Run-in Phase | NOT COMPLETED | Activity Assessment Phase | 0 | |
| Treatment Phase | STARTED | Dose-finding Phase | 0 | |
| Treatment Phase | STARTED | Activity Assessment Phase | 55 | |
| Treatment Phase | COMPLETED | Dose-finding Phase | 0 | |
| Treatment Phase | COMPLETED | Activity Assessment Phase | 13 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events210
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 | Dose-finding Phase | 14 | 22 | |
| other | Fatigue | General disorders | Activity Assessment Phase | 42 | 55 | |
| other | Constipation | Gastrointestinal disorders | Dose-finding Phase | 12 | 22 | |
| other | Constipation | Gastrointestinal disorders | Activity Assessment Phase | 21 | 55 | |
| other | Nausea | Gastrointestinal disorders | Dose-finding Phase | 10 | 22 | |
| other | Nausea | Gastrointestinal disorders | Activity Assessment Phase | 40 | 55 | |
| other | Diarrhea | Gastrointestinal disorders | Dose-finding Phase | 6 | 22 | |
| other | Diarrhea | Gastrointestinal disorders | Activity Assessment Phase | 13 | 55 | |
| other | Anorexia | Metabolism and nutrition disorders | Dose-finding Phase | 5 | 22 | |
| other | Anorexia | Metabolism and nutrition disorders | Activity Assessment Phase | 11 | 55 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose-finding Phase | ||
| Total, all-cause mortality | Activity Assessment Phase | ||
| Total, other adverse events | Dose-finding Phase | 20 | 22 |
| Total, other adverse events | Activity Assessment Phase | 54 | 55 |
| Total, serious adverse events | Dose-finding Phase | 6 | 22 |
| Total, serious adverse events | Activity Assessment Phase | 12 | 55 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21055798 | BACKGROUND |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dose-finding Phase vs Activity Assessment Phase: serious adverse events |
Source 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/NCT00316173
GET https://conductscience.org/api/trials/v1/NCT00316173/events?page=2