Trial · NCT00527124
Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
NCT00527124, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2014-03-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy. Trials, record NCT00527124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00527124
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
- NCT number
- NCT00527124
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adenocarcinoma of the Prostate, Stage IV Prostate Cancer
- Interventions
- cediranib maleate, docetaxel, prednisone, laboratory biomarker analysis
- First posted
- 2007-09-10
- Last updated
- 2018-08-09
- Results first posted
- 2014-03-11
- Limitations and caveats
- Closure was recommended by CTEP due to slow accrual.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 6-month Progression-free Survival (PFS) Proportion | Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months | The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free |
| Secondary | Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group | Up to 52 weeks | PSA \< 4.0 ng/ml. is a CR. A 50% decline or better in PSA is a PR. Less than a 50% decline in PSA and less than a 25% increase in PSA is SD. A 25% or greater increase in PSA level by at least 5 ng/mL is PD by PSA only. The point estimate and 95% Wilson CI estimates of the proportion for the Prostate-specific antigen (PSA) response will be computed . |
| Secondary | Overall Response Rate Evaluated by the RECIST Criteria | Up to 52 weeks | The overall response is determined by combining the patient's status on target lesions, PSA, non-target lesions, and new disease as defined in the following table. Target Lesions CR CR PR SD PD Any Any Any PSA Response CR PR PR Non-PD Any Any PD Any Non-Target Lesions CR Non-CR/Non-PD Non-PD Non-PD Any PD Any Any New Lesions No No No No Yes or No Yes or No Yes or No Yes Overall Response CR PR PR SD PD PD PD PD |
| Secondary | Time to Progression | The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks | Analyzed with standard K-M methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of TTP. These point and CI estimates will be reported for all patients combined, and separately for each treatment arm. |
| Secondary | Overall Survival | The time from registration date until death from any cause, assessed up to 52 weeks | Analyzed with standard K-M methodology. A 12 month survival rate will be calculated since median survival was not reached by the end of the study period. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 6-month Progression-free Survival (PFS) Proportion | Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months | Per protocol. 30 subjects on Arm I and 28 subjects on Arm II accrued for analysis of the primary endpoint of 6 mths PFS proportion. PFS is obtainable on all 58 participants enrolled, however 1 subject enrolled on Arm I withdrew before receiving any treatment, hence cannot be included for AE analysis and reporting, AE results involve 29 subjects. | percentage of patients | NUMBER |
| SECONDARY | Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group | Up to 52 weeks | proportion of evaluable patients | NUMBER | |
| SECONDARY | Overall Response Rate Evaluated by the RECIST Criteria | Up to 52 weeks | proportion of evaluable patients | NUMBER | |
| SECONDARY | Time to Progression | The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks | months | MEDIAN | |
| SECONDARY | Overall Survival | The time from registration date until death from any cause, assessed up to 52 weeks | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 6-month Progression-free Survival (PFS) Proportion | Arm I | 60 | 95% Confidence Interval 42 to 75 | percentage of patients | |
| 6-month Progression-free Survival (PFS) Proportion | Arm II | 54 | 95% Confidence Interval 36 to 71 | percentage of patients | |
| Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group | Arm I | CR | .35 | 95% Confidence Interval .19 to .54 | proportion of evaluable patients |
| Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group | Arm II | CR | .12 | 95% Confidence Interval .04 to .29 | proportion of evaluable patients |
| Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group | Arm I | PR | .27 | 95% Confidence Interval .14 to .46 | proportion of evaluable patients |
| Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group | Arm II | PR | .54 | 95% Confidence Interval .35 to .71 | proportion of evaluable patients |
| Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group | Arm I | SD | .35 | 95% Confidence Interval .19 to .54 | proportion of evaluable patients |
| Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group | Arm II | SD | .31 | 95% Confidence Interval .17 to .50 | proportion of evaluable patients |
| Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group | Arm I | PD | .04 | 95% Confidence Interval .01 to .19 | proportion of evaluable patients |
| Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group | Arm II | PD | .04 | 95% Confidence Interval .01 to .19 | proportion of evaluable patients |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I | 29 | |
| Overall Study | STARTED | Arm II | 28 | |
| Overall Study | COMPLETED | Arm I | 29 | |
| Overall Study | COMPLETED | Arm II | 28 | |
| Overall Study | NOT COMPLETED | Arm I | 0 | |
| Overall Study | NOT COMPLETED | Arm II | 0 |
Source ClinicalTrials.gov
Adverse events208
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 | Anemia | Blood and lymphatic system disorders | Arm I | 16 | 29 | 16 |
| other | Anemia | Blood and lymphatic system disorders | Arm II | 16 | 28 | 16 |
| other | Chest pain- cardiac | Cardiac disorders | Arm I | 0 | 29 | 0 |
| other | Chest pain- cardiac | Cardiac disorders | Arm II | 2 | 28 | 2 |
| other | Watering eyes | Eye disorders | Arm I | 5 | 29 | 5 |
| other | Watering eyes | Eye disorders | Arm II | 3 | 28 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Arm I | 4 | 29 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Arm II | 0 | 28 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Arm I | 6 | 29 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Arm II | 25 | 28 | 25 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I | ||
| Total, all-cause mortality | Arm II | ||
| Total, other adverse events | Arm I | 29 | |
| Total, other adverse events | Arm II | 28 | |
| Total, serious adverse events | Arm I | 20 | 29 |
| Total, serious adverse events | Arm II | 9 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants3
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| U01CA062487 | Early Clinical Trials of New Anti-Cancer Agents | LORUSSO, PATRICIA M. | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
| U01CA062491 | Early Clinical Trials of New Anti-Cancer Agents with Phase 1 Emphasis (U01) | LIU, GLENN | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I vs Arm 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/NCT00527124
GET https://conductscience.org/api/trials/v1/NCT00527124/events?page=2