Trial · NCT00653328
Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma
NCT00653328, Phase 2, Terminated, Vanderbilt-Ingram Cancer Center; results first posted 2011-04-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma. Trials, record NCT00653328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00653328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ph II Atrasentan + DOXIL in Recurrent Ovarian/Fallopian/Peritoneal Serous Papillary Adenocarcinoma
- NCT number
- NCT00653328
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- Interventions
- atrasentan hydrochloride, doxil
- First posted
- 2008-04-04
- Last updated
- 2012-05-23
- Results first posted
- 2011-04-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Time to Tumor Progression | Date on study to the date of measured progressive disease, every 2 cycles (2 months) | Tumor progression is determined by appropriate imaging techniques according to RECIST criteria or by CA-125 serum level \>=2x baseline and \>=70 IU/ml, confirmed by a second determination at least 28 days after the first determination |
| Secondary | Number of Patients With Objective Response | At month 2 and monthly thereafter to cessation of treatment | Patient response to treatment: Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started, or appearance of \>= 1 new lesions, and/or 2x CA-125 levels to \>=70 IU/ml, confirmed by second measurement after 28 days Complete response (CR): disappearance of all target lesions Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD |
| Secondary | Overall Survival | Date on study to date of death from any cause | |
| Secondary | Number of Patients With Worst Grade Toxicities | Weekly for 2 weeks, then monthly for 5 months | Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables. Tables represent the number of patients with worst-grade toxicity at each of five grades (grade 1, least severe; to grade 5, most severe) following NCI Common Toxicity Criteria |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Time to Tumor Progression | Date on study to the date of measured progressive disease, every 2 cycles (2 months) | Patients available for measurement of tumor response. One patient withdrew after beginning treatment. | Months | MEDIAN |
| SECONDARY | Number of Patients With Objective Response | At month 2 and monthly thereafter to cessation of treatment | Patients who were available for measurement of tumor response.One patient withdrew after beginning treatment and was not available for measurement. | participants | NUMBER |
| SECONDARY | Overall Survival | Date on study to date of death from any cause | All patients who received treatment. Two patients alive at last follow-up. | Months | MEDIAN |
| SECONDARY | Number of Patients With Worst Grade Toxicities | Weekly for 2 weeks, then monthly for 5 months | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Median Time to Tumor Progression | Altrasentan + Doxil | 1 | Full Range 2.9 | Months | |
| Number of Patients With Objective Response | Altrasentan + Doxil | Complete Response | 0 | participants | |
| Number of Patients With Objective Response | Altrasentan + Doxil | Partial Response | 0 | participants | |
| Number of Patients With Objective Response | Altrasentan + Doxil | Stable Disease | 3 | participants | |
| Number of Patients With Objective Response | Altrasentan + Doxil | Progressive Disease | 11 | participants | |
| Overall Survival | Altrasentan + Doxil | 10 | Full Range 1 to 33 | Months | |
| Number of Patients With Worst Grade Toxicities | Altrasentan + Doxil | Number of participants with worst grade toxicity 1 | 5 | participants | |
| Number of Patients With Worst Grade Toxicities | Altrasentan + Doxil | Number of participants with worst grade toxicity 2 | 3 | participants | |
| Number of Patients With Worst Grade Toxicities | Altrasentan + Doxil | Number of participants with worst grade toxicity 3 | 3 | participants | |
| Number of Patients With Worst Grade Toxicities | Altrasentan + Doxil | Number of participants with worst grade toxicity 4 | 0 | participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Altrasentan + Doxil | 15 | |
| Overall Study | COMPLETED | Altrasentan + Doxil | 0 | |
| Overall Study | NOT COMPLETED | Altrasentan + Doxil | 15 |
Source ClinicalTrials.gov
Adverse events84
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 | Hemoglobin | Blood and lymphatic system disorders | Altrasentan + Doxil | 7 | 15 | 50 |
| other | fatigue | General disorders | Altrasentan + Doxil | 10 | 15 | 34 |
| other | Hypoalbuminemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Altrasentan + Doxil | 1 | 15 | 1 |
| other | Hyponatremia | Metabolism and nutrition disorders | Altrasentan + Doxil | 1 | 15 | 2 |
| other | pelvic pain | Reproductive system and breast disorders | Altrasentan + Doxil | 2 | 15 | 2 |
| other | Urinary urgency | Renal and urinary disorders | Altrasentan + Doxil | 1 | 15 | 2 |
| other | Nausea | Gastrointestinal disorders | Altrasentan + Doxil | 5 | 15 | 8 |
| other | Vomiting | Gastrointestinal disorders | Altrasentan + Doxil | 4 | 15 | 5 |
| other | Abdominal Pain | Gastrointestinal disorders | Altrasentan + Doxil | 4 | 15 | 4 |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Altrasentan + Doxil | 8 | 15 | 11 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Altrasentan + Doxil | ||
| Total, other adverse events | Altrasentan + Doxil | 15 | 15 |
| Total, serious adverse events | Altrasentan + Doxil | 5 | 15 |
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/NCT00653328
GET https://conductscience.org/api/trials/v1/NCT00653328/events?page=2