Trial · NCT00114166
Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
NCT00114166, Phase 2, Completed, Gynecologic Oncology Group; results first posted 2014-06-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer. Trials, record NCT00114166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00114166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
- NCT number
- NCT00114166
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Interventions
- topotecan hydrochloride
- First posted
- 2005-06-14
- Last updated
- 2018-07-24
- Results first posted
- 2014-06-26
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Tumor Response | Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal | Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease. |
| Primary | Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0 | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up | |
| Secondary | Reason Off Study Therapy | study entry through end of study treatment, up to 5 years |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Tumor Response | Every other cycle for the first 6 months, then every 3 months x2, then every 6 months until disease progression or study withdrawal | Eligible and evaluable participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0 | Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up | Eligible and treated patients | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Reason Off Study Therapy | study entry through end of study treatment, up to 5 years | Eligible and evaluable participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Tumor Response | Regimen I (Topotecan 1.25 mg/m2) | Partial Response | 4 | Participants | |
| Objective Tumor Response | Regimen II (Topotecan 4.0 mg/m2) | Partial Response | 8 | Participants | |
| Objective Tumor Response | Regimen I (Topotecan 1.25 mg/m2) | Stable Disease | 8 | Participants | |
| Objective Tumor Response | Regimen II (Topotecan 4.0 mg/m2) | Stable Disease | 32 | Participants | |
| Objective Tumor Response | Regimen I (Topotecan 1.25 mg/m2) | Increase Disease | 2 | Participants | |
| Objective Tumor Response | Regimen II (Topotecan 4.0 mg/m2) | Increase Disease | 21 | Participants | |
| Objective Tumor Response | Regimen I (Topotecan 1.25 mg/m2) | Indeterminate | 1 | Participants | |
| Objective Tumor Response | Regimen II (Topotecan 4.0 mg/m2) | Indeterminate | 4 | Participants | |
| Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0 | Regimen I | Leukopenia | 10 | Participants | |
| Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Toxicity Criteria for Adverse Events Version 2.0 | Regimen II | Leukopenia | 6 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen I (Topotecan 1.25 mg/m2) | 15 | |
| Overall Study | STARTED | Regimen II (Topotecan 4.0 mg/m2 ) | 66 | |
| Overall Study | COMPLETED | Regimen I (Topotecan 1.25 mg/m2) | 15 | |
| Overall Study | COMPLETED | Regimen II (Topotecan 4.0 mg/m2 ) | 65 | |
| Overall Study | NOT COMPLETED | Regimen I (Topotecan 1.25 mg/m2) | 0 | |
| Overall Study | NOT COMPLETED | Regimen II (Topotecan 4.0 mg/m2 ) | 1 |
Source ClinicalTrials.gov
Adverse events356
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 | Allergic Reaction/Hypersensitivity | Immune system disorders | Regimen I | 0 | 15 | |
| other | Allergic Reaction/Hypersensitivity | Immune system disorders | Regimen II | 3 | 65 | |
| other | Rhinitis | Immune system disorders | Regimen I | 0 | 15 | |
| other | Rhinitis | Immune system disorders | Regimen II | 3 | 65 | |
| other | Hearing (Without Monitoring Program) | Ear and labyrinth disorders | Regimen I | 0 | 15 | |
| other | Hearing (Without Monitoring Program) | Ear and labyrinth disorders | Regimen II | 2 | 65 | |
| other | Tinnitus | Ear and labyrinth disorders | Regimen I | 0 | 15 | |
| other | Tinnitus | Ear and labyrinth disorders | Regimen II | 2 | 65 | |
| other | Neutrophils | Blood and lymphatic system disorders | Regimen I | 9 | 15 | |
| other | Neutrophils | Blood and lymphatic system disorders | Regimen II | 44 | 65 |
1 to 10 of 356Source ClinicalTrials.gov
See all 356 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen I | ||
| Total, all-cause mortality | Regimen II | ||
| Total, other adverse events | Regimen I | 10 | 15 |
| Total, other adverse events | Regimen II | 60 | 65 |
| Total, serious adverse events | Regimen I | 8 | 15 |
| Total, serious adverse events | Regimen II | 10 | 65 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21168198 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Regimen I vs Regimen II: 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/NCT00114166
GET https://conductscience.org/api/trials/v1/NCT00114166/results?page=2