Trial · NCT02065687
Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
NCT02065687, Phase 2, Phase 3, Unknown, Gynecologic Oncology Group; results first posted 2021-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer. Trials, record NCT02065687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02065687
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
- NCT number
- NCT02065687
- Status
- Unknown
- Phases
- Phase 2, Phase 3
- Enrollment
- 469 participants, actual
- Lead sponsor
- Gynecologic Oncology Group
- Conditions
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Recurrent Uterine Corpus Carcinoma, Stage III Uterine Corpus Cancer AJCC v7, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage IIIB Uterine Corpus Cancer AJCC v7, Stage IIIC Uterine Corpus Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7, Stage IVA Uterine Corpus Cancer AJCC v7, Stage IVB Uterine Corpus Cancer AJCC v7
- Interventions
- Carboplatin, Laboratory Biomarker Analysis, Metformin Hydrochloride, Paclitaxel, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
- First posted
- 2014-02-19
- Last updated
- 2021-09-30
- Results first posted
- 2021-01-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) (Phase II) | From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years | Time until disease progression, death, or date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined. |
| Primary | Overall Survival (OS) (Phase II and III) | From date of study entry to time of death or the date of last contact, assessed up to 5 years | The observed length of life from randomization into the study to death or the date of last contact. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined. |
| Secondary | Proportion of Patients Responding to Therapy | During study treatment, up to 5 years. | The proportion of patients who had a response (complete or partial) by RECIST 1.1. Measurable disease is defined by RECIST (version 1.1). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT, MRI or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray. Lymph nodes must be \> 15 mm in short axis when measured by CT or MRI. |
| Secondary | Duration of Response by Treatment | From the date of response to disease progression, death, or date last seen assessed up to 5 years | Duration of response until disease progression, death, or date last seen among patients who responded. |
| Secondary | Overall Survival (OS) (Phase II) | From date of study entry to time of death or the date of last contact, assessed up to 5 years. | The observed length of life from randomization into the study to death or the date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined. |
| Secondary | Progression Free Survival (PFS) (Phase III) | From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years | Time until disease progression, death, or date of last contact. For response, only those patients who had measurable disease were included in an analysis of response. Non-measurable patients are included in the ITT analysis. This study was originally designed as a phase II/III study. It passed the phase 2 threshold and started the phase 3; however, a phase 3 interim analysis stopped the trial for futility. Therefore, data available for Phase III may be identical to data reported for Phase II or Phase II/III combined. |
| Secondary | Number of Participants With Grade 3 or Higher Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4 | Up to 5 years | Toxicities will be assessed by organ or organ system. For each category of toxicity, each patient will be evaluated by the worst grade experienced during the course of therapy. Data will be summarized by frequency and severity according to the regimen administered. The number of patients with a grade three or greater adverse event will be reported (by system organ class). |
| Secondary | Level of Obesity | Up to 5 years | Obesity will be quantitative assessed by body mass index (BMI) and will be assessed for its predictive and prognostic significance. The interaction between BMI and metformin treatment will be examined with an interaction term in a Cox proportional hazards model. |
| Other | Metabolic Factor Levels | Up to 5 years | Hip-to-waist ratio, diabetes status, hemoglobin A1c, fasting insulin glucose levels, and homeostatic model assessment scores will be assessed for their predictive and prognostic significance. Variables will be analyzed as continuous covariates (or as appropriate with transformations such as the logarithm) with Cox models or logistic regression. |
| Other | Incidence of PIK3 Mutations/Amplifications | Up to 5 years | PIK3CA mutations/amplifications and PIK3R1/PIK3R2 mutations will be examined for prognostic and predictive significance. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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) (Phase II) | From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years | All patients | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) (Phase II and III) | From date of study entry to time of death or the date of last contact, assessed up to 5 years | All patients. | Months | MEDIAN |
| SECONDARY | Proportion of Patients Responding to Therapy | During study treatment, up to 5 years. | Evaluable for response | percentage of patients | NUMBER |
| SECONDARY | Duration of Response by Treatment | From the date of response to disease progression, death, or date last seen assessed up to 5 years | Patients who responded | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) (Phase II) | From date of study entry to time of death or the date of last contact, assessed up to 5 years. | All patients | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) (Phase III) | From date of study entry to time of progression or death, whichever occurs first, assessed up to 5 years | All patients. | Months | MEDIAN |
| SECONDARY | Number of Participants With Grade 3 or Higher Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4 | Up to 5 years | All patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Level of Obesity | Up to 5 years | All patients | proportion of participants obese | NUMBER |
| OTHER_PRE_SPECIFIED | Metabolic Factor Levels | Up to 5 years | |||
| OTHER_PRE_SPECIFIED | Incidence of PIK3 Mutations/Amplifications | Up to 5 years |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group56
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) (Phase II) | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 9.0 | 95% Confidence Interval 8.4 to 10.5 | Months | |
| Progression-free Survival (PFS) (Phase II) | Arm II (Paclitaxel, Carboplatin, Placebo) | 8.5 | 95% Confidence Interval 8.0 to 10.3 | Months | |
| Overall Survival (OS) (Phase II and III) | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 34.6 | 95% Confidence Interval 28.0 to 50.1 | Months | |
| Overall Survival (OS) (Phase II and III) | Arm II (Paclitaxel, Carboplatin, Placebo) | 30.4 | 95% Confidence Interval 24.6 to 37.8 | Months | |
| Proportion of Patients Responding to Therapy | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 61.6 | 95% Confidence Interval 53.7 to 69.1 | percentage of patients | |
| Proportion of Patients Responding to Therapy | Arm II (Paclitaxel, Carboplatin, Placebo) | 60.2 | 95% Confidence Interval 52.5 to 67.6 | percentage of patients | |
| Duration of Response by Treatment | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 8.0 | 95% Confidence Interval 6.3 to 9.4 | Months | |
| Duration of Response by Treatment | Arm II (Paclitaxel, Carboplatin, Placebo) | 8.0 | 95% Confidence Interval 6.2 to 10.3 | Months | |
| Overall Survival (OS) (Phase II) | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 34.6 | 95% Confidence Interval 28.0 to 50.1 | Months | |
| Overall Survival (OS) (Phase II) | Arm II (Paclitaxel, Carboplatin, Placebo) | 30.4 | 95% Confidence Interval 24.6 to 37.8 | Months |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 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 (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 234 | |
| Overall Study | STARTED | Arm II (Paclitaxel, Carboplatin, Placebo) | 235 | |
| Overall Study | COMPLETED | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 234 | |
| Overall Study | COMPLETED | Arm II (Paclitaxel, Carboplatin, Placebo) | 235 | |
| Overall Study | NOT COMPLETED | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 0 | |
| Overall Study | NOT COMPLETED | Arm II (Paclitaxel, Carboplatin, Placebo) | 0 |
Source ClinicalTrials.gov
Adverse events728
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 | Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 1 | 234 | |
| other | Thrombotic Thrombocytopenic Purpura | Blood and lymphatic system disorders | Arm II (Paclitaxel, Carboplatin, Placebo) | 0 | 235 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 1 | 234 | |
| other | Lymph Node Pain | Blood and lymphatic system disorders | Arm II (Paclitaxel, Carboplatin, Placebo) | 1 | 235 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 2 | 234 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Arm II (Paclitaxel, Carboplatin, Placebo) | 1 | 235 | |
| other | Anemia | Blood and lymphatic system disorders | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 168 | 234 | |
| other | Anemia | Blood and lymphatic system disorders | Arm II (Paclitaxel, Carboplatin, Placebo) | 154 | 235 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 9 | 234 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Arm II (Paclitaxel, Carboplatin, Placebo) | 5 | 235 |
1 to 10 of 728Source ClinicalTrials.gov
See all 728 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, Metformin Hydrochloride) | 95 | 234 |
| Total, all-cause mortality | Arm II (Paclitaxel, Carboplatin, Placebo) | 95 | 235 |
| Total, other adverse events | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 222 | 234 |
| Total, other adverse events | Arm II (Paclitaxel, Carboplatin, Placebo) | 222 | 235 |
| Total, serious adverse events | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | 46 | 234 |
| Total, serious adverse events | Arm II (Paclitaxel, Carboplatin, Placebo) | 53 | 235 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| U10CA180830 | NCI NCTN- Network Lead Academic Participating Site: USC | LENZ, HEINZ JOSEF; EL-KHOUEIRY, ANTHONY BOUTROS; QUINN, DAVID IAN | UNIVERSITY OF SOUTHERN CALIFORNIA | NATIONAL CANCER INSTITUTE | 2014 to 2018 | NIH RePORTER |
| U10CA027469 | Gynecologic Oncology Group | DISAIA, PHILIP J. | GYNECOLOGIC ONCOLOGY GROUP | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) vs Arm II (Paclitaxel, Carboplatin, Placebo): deaths from any cause | Trial comparisons |
| Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) vs Arm II (Paclitaxel, Carboplatin, Placebo): 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/NCT02065687
GET https://conductscience.org/api/trials/v1/NCT02065687/results?page=2