Carboplatin, Docetaxel, and Radiation Therapy in Treating Patients With Stage III/IV, or Recurrent Endometrial Cancer

This study has been completed.

Sponsor:

Collaborator:

Sanofi

Information provided by (Responsible Party):

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT00258362

First received: November 22, 2005

Last updated: November 6, 2012

Last verified: November 2012

History of Changes

Results First Received: August 20, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Endometrial Cancer
Interventions:	Drug: carboplatin Drug: docetaxel Radiation: radiation therapy

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
42 patients consented originally, but 1 patient withdrew consent before receiving any treatment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Patients With Endometrial Cancer	Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.

Participant Flow: Overall Study

	Patients With Endometrial Cancer
STARTED	41
COMPLETED	41
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Patients With Endometrial Cancer	Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. This group excludes those patients with recurrent endometrial cancer.

Baseline Measures

	Patients With Endometrial Cancer
Number of Participants [units: participants]	41
Age [units: participants]
<=18 years	0
Between 18 and 65 years	30
>=65 years	11
Age [units: years] Mean ± Standard Deviation	59.0 ± 11.5
Gender [units: participants]
Female	41
Male	0
Race/Ethnicity, Customized [units: Participants]
White	35
Black	1
Hispanic	2
Other	2
Unknown	1
Region of Enrollment [units: participants]
United States	41
Histology ^[1] [units: Participants]
Endometroid	32
Serous	4
Mucinous	1
Adenosquamous	3
Endometroid + Serous	1

[1]	Type or classification of cancer

Outcome Measures

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1. Primary:

Percent of Patients Estimated to be Progression-Free and Alive [ Time Frame: 1 Year, 2 Years, 3 Years ]

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2. Secondary:

Percent of Patients Estimated to be Alive [ Time Frame: 1 Year, 2 Years, 3 Years ]

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Serious Adverse Events

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Time Frame	Serious, related adverse events and other adverse events were collected from day 1 of treatment to 30 days post-treatment. Deaths outside the collection timeframe were not reported.
Additional Description	Other adverse events were collected only once per patient (incidence); the number of events for each adverse event were not collected (frequency).

Reporting Groups

	Description
Patients With Endometrial Cancer	Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.

Serious Adverse Events

	Patients With Endometrial Cancer
Total, serious adverse events
# participants affected / at risk	8/41 (19.51%)
Blood and lymphatic system disorders
Lymphocele ^{† 1}
# participants affected / at risk	1/41 (2.44%)
# events	1
Gastrointestinal disorders
Dehydration ^{† 1}
# participants affected / at risk	2/41 (4.88%)
# events	2
Nausea ^{† 1}
# participants affected / at risk	1/41 (2.44%)
# events	1
Vomiting ^{† 1}
# participants affected / at risk	1/41 (2.44%)
# events	1
Infections and infestations
Blood Infection ^{† 1}
# participants affected / at risk	1/41 (2.44%)
# events	1
Febrile Neutropenia ^{† 1}
# participants affected / at risk	1/41 (2.44%)
# events	1
Renal and urinary disorders
Bladder Infection ^{† 1}
# participants affected / at risk	2/41 (4.88%)
# events	2
Stricture/stenosis of ureter ^{† 1}
# participants affected / at risk	1/41 (2.44%)
# events	1
Respiratory, thoracic and mediastinal disorders
Metastatic disease to lung ^{† 1 [3]}
# participants affected / at risk	1/41 (2.44%)
# events	1
Vascular disorders
Thrombosis/embolism ^{† 1}
# participants affected / at risk	1/41 (2.44%)
# events	1

†	Events were collected by systematic assessment
1	Term from vocabulary, CTCAE (3.0)
[3]	Resulted in death

Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Melissa Geller, M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-626-3111
e-mail: gelle005@umn.edu

No publications provided

Responsible Party:	Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:	NCT00258362 History of Changes
Other Study ID Numbers:	2004LS021, UMN-WCC-38, 13062
Study First Received:	November 22, 2005
Results First Received:	August 20, 2010
Last Updated:	November 6, 2012
Health Authority:	United States: Food and Drug Administration

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