Trial · NCT00170573
Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer
NCT00170573, Phase 2, Completed, North Eastern German Society of Gynaecological Oncology; results first posted 2024-12-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer. Trials, record NCT00170573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00170573
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer
- NCT number
- NCT00170573
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- North Eastern German Society of Gynaecological Oncology
- Conditions
- Ovarian Cancer
- Interventions
- Caelyx
- First posted
- 2005-09-15
- Last updated
- 2024-12-16
- Results first posted
- 2024-12-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | through study completion, an average of 18 months | The outcome will be measured by number of participants with reported skin toxicity PPE of CTC (Common Toxicity Criteria)-Grade I / II / III / IV. Grade I - Dysesthesia/paraesthesia tingling of hands and feet; Grade II - Discomfort in holding objects and upon walking, painless swelling and erythema; Grade III - painful erythema and swelling of palms and soles, periungual erythema and swelling; Grade IV - Desquamation, ulceration, blistering, severe pain |
| Secondary | Overall Survival | for up to 3 years | Overall survival estimated by the Kaplan-Meier method |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | through study completion, an average of 18 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | for up to 3 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | Caelyx | CTC-Grade I | 18 | Participants | |
| Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | Caelyx | CTC-Grade II | 9 | Participants | |
| Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | Caelyx | CTC-Grade III | 3 | Participants | |
| Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | Caelyx | CTC-Grade IV | 0 | Participants | |
| Occurrence of Palmar-plantar Erythrodysesthesia (PPE) | Caelyx | no PPE | 34 | Participants | |
| Overall Survival | Caelyx | 18.2 | Full Range 1.4 to 34.0 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Caelyx | 77 | |
| Overall Study | COMPLETED | Caelyx | 64 | |
| Overall Study | NOT COMPLETED | Caelyx | 13 |
Source ClinicalTrials.gov
Adverse events5
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 | Leucopenia | Blood and lymphatic system disorders | Caelyx | 26 | 64 | |
| other | PPE | Skin and subcutaneous tissue disorders | Caelyx | 30 | 64 | |
| other | Thrombopenia | Blood and lymphatic system disorders | Caelyx | 4 | 64 | |
| serious | Anemia | Blood and lymphatic system disorders | Caelyx | 3 | 64 | |
| serious | Thrombopenia | Blood and lymphatic system disorders | Caelyx | 1 | 64 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Caelyx | ||
| Total, other adverse events | Caelyx | 60 | 64 |
| Total, serious adverse events | Caelyx | 4 | 64 |
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 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/NCT00170573
GET https://conductscience.org/api/trials/v1/NCT00170573/registered