Trial · NCT01012297

Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma

NCT01012297, Phase 3, Terminated, National Cancer Institute (NCI); results first posted 2017-07-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma. Trials, record NCT01012297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01012297

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma
NCT number: NCT01012297
Status: Terminated
Phases: Phase 3
Enrollment: 107 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Uterine Corpus Sarcoma, Stage IIIA Uterine Sarcoma, Stage IIIB Uterine Sarcoma, Stage IIIC Uterine Sarcoma, Stage IVA Uterine Sarcoma, Stage IVB Uterine Sarcoma, Uterine Corpus Leiomyosarcoma
Interventions: Bevacizumab, Docetaxel, Filgrastim, Gemcitabine Hydrochloride, Pegfilgrastim, Placebo
First posted: 2009-11-13
Last updated: 2026-06-24
Results first posted: 2017-07-14
Limitations and caveats: The study was targeted to accrue 130 patients, but closed early for futility. Early termination leading to small numbers of subjects analyzed.

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	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months	Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.
Secondary	Overall Survival	Up to 5 years	Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan. The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group.
Secondary	Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0	Up to 5 years	Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse. Please refer to the adverse event reporting for more detail.
Secondary	Objective Response Rate as Measured by RECIST 1.1 Criteria	Up to 5 years	"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) 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.

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	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months	All randomized	months	MEDIAN
SECONDARY	Overall Survival	Up to 5 years	All randomized	months	MEDIAN
SECONDARY	Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0	Up to 5 years	All randomized.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Objective Response Rate as Measured by RECIST 1.1 Criteria	Up to 5 years	All randomized	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-free Survival	Arm I Gem+Doce+Placebo	6.2	95% Confidence Interval 2.9 to 9.9	months
Progression-free Survival	Arm II Gem+Doce+Bev	4.2	95% Confidence Interval 3.1 to 8.4	months
Overall Survival	Arm I Gem+Doce+Placebo	26.9	95% Confidence Interval 15.9 to 32.1	months
Overall Survival	Arm II Gem+Doce+Bev	23.3	95% Confidence Interval 16.6 to 27.3	months
Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0	Arm I Gem+Doce+Placebo	36		Participants
Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0	Arm II Gem+Doce+Bev	46		Participants
Objective Response Rate as Measured by RECIST 1.1 Criteria	Arm I Gem+Doce+Placebo	31.5	95% Confidence Interval 21.2 to 43.4	percentage of participants
Objective Response Rate as Measured by RECIST 1.1 Criteria	Arm II Gem+Doce+Bev	35.8	95% Confidence Interval 24.9 to 48.0	percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I Gem+Doce+Placebo	54
Overall Study	STARTED	Arm II Gem+Doce+Bev	53
Overall Study	COMPLETED	Arm I Gem+Doce+Placebo	54
Overall Study	COMPLETED	Arm II Gem+Doce+Bev	53
Overall Study	NOT COMPLETED	Arm I Gem+Doce+Placebo	0
Overall Study	NOT COMPLETED	Arm II Gem+Doce+Bev	0

Source ClinicalTrials.gov

Adverse events492

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
other	Thrombotic Thrombocytopenic Purpura	Blood and lymphatic system disorders	Arm I	0	54
other	Thrombotic Thrombocytopenic Purpura	Blood and lymphatic system disorders	Arm II	1	53
other	Blood And Lymphatic System Disorders - Other	Blood and lymphatic system disorders	Arm I	1	54
other	Blood And Lymphatic System Disorders - Other	Blood and lymphatic system disorders	Arm II	2	53
other	Anemia	Blood and lymphatic system disorders	Arm I	47	54
other	Anemia	Blood and lymphatic system disorders	Arm II	48	53
other	Palpitations	Cardiac disorders	Arm I	2	54
other	Palpitations	Cardiac disorders	Arm II	3	53
other	Pericardial Effusion	Cardiac disorders	Arm I	1	54
other	Pericardial Effusion	Cardiac disorders	Arm II	1	53

1 to 10 of 492Source ClinicalTrials.gov

See all 492 adverse events

Adverse 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	51	54
Total, other adverse events	Arm II	51	53
Total, serious adverse events	Arm I	17	54
Total, serious adverse events	Arm II	21	53

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25713428	DERIVED	PubMed
34298376	DERIVED	PubMed

Grants1

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
U10CA027469	Gynecologic Oncology Group	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm I Gem+Doce+Placebo vs Arm II Gem+Doce+Bev: Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0	Trial comparisons
Arm I vs Arm II: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01012297

GET https://conductscience.org/api/trials/v1/NCT01012297/events?page=2

API reference For AI assistants