Trial · NCT00278343
Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer
NCT00278343, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-07-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer. Trials, record NCT00278343. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00278343
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cediranib Maleate in Treating Patients With Persistent, Recurrent, or Refractory Advanced Ovarian Epithelial, Peritoneal Cavity, or Fallopian Tube Cancer
- NCT number
- NCT00278343
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 74 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer
- Interventions
- cediranib maleate, laboratory biomarker analysis
- First posted
- 2006-01-18
- Last updated
- 2018-08-29
- Results first posted
- 2017-07-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria | After 16 weeks | 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 | Time to Disease Progression | Up to 4 years | Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. |
| Secondary | Overall Survival (OS) (Discontinued as of 4/25/2014) | From date of radomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months. | The Kaplan-Meier method will be used to estimate OS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. |
| Secondary | Progression-free Survival (PFS) | Time from start of treatment to time of progression, assessed up to 6 months | The Kaplan-Meier method will be used to estimate PFS. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible. 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 | Duration of Overall CA-125 Response | Up to 4 years | Confirmed response on CA125 - defined as reduction in level of pre-treatment sample by \> 50%. |
| Secondary | Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0 | Up to 4 years |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria | After 16 weeks | Total # of Patients 74 PL-S (platinum sensitive) 39 patients PL-R (platinum resistant) 35 patients Confirmed PR PL-S group 9/39 patients Confirmed PR PL-R group 0/35 patients | participants | NUMBER |
| SECONDARY | Time to Disease Progression | Up to 4 years | Platinum sensitive cohort | months | MEDIAN |
| SECONDARY | Overall Survival (OS) (Discontinued as of 4/25/2014) | From date of radomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 32 months. | months | MEDIAN | |
| SECONDARY | Progression-free Survival (PFS) | Time from start of treatment to time of progression, assessed up to 6 months | months | MEDIAN | |
| SECONDARY | Duration of Overall CA-125 Response | Up to 4 years | 1 confirmed PR observed in PS group. Response will be defined as reduction in level of pre-treatment sample by \> 50%.~0 confirmed PR observed in PR group. | weeks | NUMBER |
| SECONDARY | Incidence of Toxicity Graded According to National Cancer Institution Common Terminology Criteria for Adverse Events Version 3.0 | Up to 4 years | Data were not collected. |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria | Treatment (Cediranib Maleate) | Platinum sensitive participants | 9 | participants | |
| Response Benefit (Complete Response or Partial Response or Stable Disease) Based on the RECIST/Rustin Criteria | Treatment (Cediranib Maleate) | Platinum resistant participants | 0 | participants | |
| Time to Disease Progression | Treatment (Cediranib Maleate) | Platinum Sensitive Participants | 7.2 | 95% Confidence Interval 3.9 to 9.4 | months |
| Time to Disease Progression | Treatment (Cediranib Maleate) | Platinum Resistant Participants | 3.7 | 95% Confidence Interval 3.4 to 4.5 | months |
| Overall Survival (OS) (Discontinued as of 4/25/2014) | Treatment (Cediranib Maleate) | 18.9 | 95% Confidence Interval 13.5 to 31.5 | months | |
| Progression-free Survival (PFS) | Treatment (Cediranib Maleate) | 4.9 | 95% Confidence Interval 3.9 to 7 | months | |
| Duration of Overall CA-125 Response | Treatment (Cediranib Maleate) | Platinum sensitive participants | 108 | weeks |
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 | Treatment (Cediranib Maleate) | 74 | |
| Overall Study | COMPLETED | Treatment (Cediranib Maleate) | 74 | |
| Overall Study | NOT COMPLETED | Treatment (Cediranib Maleate) | 0 |
Source ClinicalTrials.gov
Adverse events12
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 | Myocardial infarction | Cardiac disorders | Treatment (Cediranib Maleate) | 2 | 74 | 2 |
| other | Small intestinal obstruction | Gastrointestinal disorders | Treatment (Cediranib Maleate) | 4 | 74 | 4 |
| other | Thromboembolic event | Vascular disorders | Treatment (Cediranib Maleate) | 2 | 74 | 2 |
| other | Hypertension | Vascular disorders | Treatment (Cediranib Maleate) | 18 | 74 | 18 |
| other | fatigue | General disorders | Treatment (Cediranib Maleate) | 13 | 74 | 13 |
| other | diarrhea | Gastrointestinal disorders | Treatment (Cediranib Maleate) | 7 | 74 | 7 |
| other | headache | Nervous system disorders | Treatment (Cediranib Maleate) | 47 | 74 | 47 |
| serious | Sinus tachycardia | Cardiac disorders | Treatment (Cediranib Maleate) | 1 | 74 | 1 |
| serious | Hypomagnesemia | Metabolism and nutrition disorders | Treatment (Cediranib Maleate) | 1 | 74 | 1 |
| serious | Death NOS | General disorders | Treatment (Cediranib Maleate) | 1 | 74 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Cediranib Maleate) | ||
| Total, other adverse events | Treatment (Cediranib Maleate) | 47 | 74 |
| Total, serious adverse events | Treatment (Cediranib Maleate) | 5 | 74 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25895616 | DERIVED |
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 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/NCT00278343
GET https://conductscience.org/api/trials/v1/NCT00278343/registered