Trial · NCT01042522
Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors
NCT01042522, Phase 2, Unknown, GOG Foundation; results first posted 2022-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors. Trials, record NCT01042522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01042522
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors
- NCT number
- NCT01042522
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- GOG Foundation
- Conditions
Ovarian Granulosa Cell Tumor, Ovarian Gynandroblastoma, Ovarian Sertoli-Leydig Cell Tumor, Ovarian Sex Cord Tumor With Annular Tubules, Ovarian Sex Cord-Stromal Tumor, Ovarian Sex Cord-Stromal Tumor, Not Otherwise Specified, Ovarian Steroid Cell Tumor
- Interventions
- Bleomycin Sulfate, Carboplatin, Cisplatin, Etoposide Phosphate, Laboratory Biomarker Analysis, Paclitaxel
- First posted
- 2010-01-05
- Last updated
- 2022-01-25
- Results first posted
- 2022-01-25
- Limitations and caveats
An interim analysis was planned occur after 20 PFS events were observed in either arm (roughly 50% information time). The futility threshold for paclitaxel and carboplatin relative to BEP was HR\>1.10. Median followup time was 48 months.~The study closed at the interim analysis for futility, and difficulty with accrual. At the time of closures, 63 of a planned 128 patients had enrolled at the time of accrual suspension.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months. | The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). |
| Secondary | Tumor Response Rate | Median followup time was 48 months. | Proportion of evaluable patients with complete or partial tumor response by RECIST 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (ORR = CR + PR). |
| Secondary | Overall Survival (OS) | From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months. | The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported. |
| Other | Change in Inhibin A and Inhibin B Levels | Baseline to up to 2 years | Pre-treatment levels of inhibin A and inhibin B will be examined in relation to OS and PFS in Cox proportional hazards models. Changes from baseline in inhibin levels will be compared between treatment groups using mixed effects models accounting for the longitudinal nature of the data. The repeated measures of inhibin will also be explored versus overall survival and PFS using time-dependent covariates in Cox proportional hazards models. |
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 | Progression-free Survival (PFS) | From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months. | Intent to Treat | months | MEDIAN |
| SECONDARY | Tumor Response Rate | Median followup time was 48 months. | Patients with at least one target lesion by RECIST 1.1 criteria and and at least one CT tumor assessment | proportion of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months. | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in Inhibin A and Inhibin B Levels | Baseline to up to 2 years |
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 |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Arm I (Paclitaxel, Carboplatin) | 27.7 | 95% Confidence Interval 11.2 to 41.0 | months | |
| Progression-free Survival (PFS) | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 19.7 | 95% Confidence Interval 10.4 to 52.7 | months | |
| Tumor Response Rate | Arm I (Paclitaxel, Carboplatin) | 0.43 | 95% Confidence Interval 0.21 to 0.67 | proportion of participants | |
| Tumor Response Rate | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 0.54 | 95% Confidence Interval 0.29 to 0.77 | proportion of participants | |
| Overall Survival (OS) | Arm I (Paclitaxel, Carboplatin) | 5 | Participants | ||
| Overall Survival (OS) | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 8 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Paclitaxel, Carboplatin) | 31 | |
| Overall Study | STARTED | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 32 | |
| Overall Study | COMPLETED | Arm I (Paclitaxel, Carboplatin) | 23 | |
| Overall Study | COMPLETED | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 26 | |
| Overall Study | NOT COMPLETED | Arm I (Paclitaxel, Carboplatin) | 8 | |
| Overall Study | NOT COMPLETED | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 6 |
Source ClinicalTrials.gov
Adverse events340
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 | Leukocytosis | Blood and lymphatic system disorders | Arm I (Paclitaxel, Carboplatin) | 0 | 31 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 2 | 32 | |
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Arm I (Paclitaxel, Carboplatin) | 3 | 31 | |
| other | Blood And Lymphatic System Disorders - Other | Blood and lymphatic system disorders | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 2 | 32 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Paclitaxel, Carboplatin) | 26 | 31 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 26 | 32 | |
| other | Atrial Fibrillation | Cardiac disorders | Arm I (Paclitaxel, Carboplatin) | 0 | 31 | |
| other | Atrial Fibrillation | Cardiac disorders | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 1 | 32 | |
| other | Sinus Bradycardia | Cardiac disorders | Arm I (Paclitaxel, Carboplatin) | 0 | 31 | |
| other | Sinus Bradycardia | Cardiac disorders | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 1 | 32 |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Paclitaxel, Carboplatin) | 5 | 31 |
| Total, all-cause mortality | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 8 | 32 |
| Total, other adverse events | Arm I (Paclitaxel, Carboplatin) | 31 | 31 |
| Total, other adverse events | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 29 | 32 |
| Total, serious adverse events | Arm I (Paclitaxel, Carboplatin) | 6 | 31 |
| Total, serious adverse events | Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin) | 11 | 32 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39265466 | DERIVED |
Source PubMed
Grants2
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 |
|---|---|---|---|---|---|---|
| U10CA180868 | NRG Oncology Network Group Operations Center | WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S. | NRG ONCOLOGY FOUNDATION, INC. | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Paclitaxel, Carboplatin) vs Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin): Overall Survival (OS) | Trial comparisons |
| Arm I (Paclitaxel, Carboplatin) vs Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin): deaths from any cause | Trial comparisons |
| Arm I (Paclitaxel, Carboplatin) vs Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin): serious adverse events | 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/NCT01042522
GET https://conductscience.org/api/trials/v1/NCT01042522/events?page=2