A Phase II Study of Paclitaxel and Carboplatin in Patients With an Elevated-Risk Cancer of the Uterus

This study has been terminated.

(low accrual)

Sponsor:

Information provided by (Responsible Party):

J. Michael Straughn, MD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00584909

First received: December 21, 2007

Last updated: February 28, 2012

Last verified: January 2012

History of Changes

Results First Received: September 21, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Uterine Cancer
Intervention:	Drug: Paclitaxel and carboplatin combination

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
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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
Paclitaxel + Carboplatin	Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.

Participant Flow: Overall Study

	Paclitaxel + Carboplatin
STARTED	13
COMPLETED	9
NOT COMPLETED	4
Adverse Event	4

Baseline Characteristics

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Reporting Groups

	Description
Paclitaxel + Carboplatin	Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.

Baseline Measures

	Paclitaxel + Carboplatin
Number of Participants [units: participants]	13
Age [units: participants]
<=18 years	0
Between 18 and 65 years	8
>=65 years	5
Age [units: years] Mean ± Standard Deviation	63 ± 6
Gender [units: participants]
Female	13
Male	0
Region of Enrollment [units: participants]
United States	13

Outcome Measures

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1. Primary:

Disease-free Survival [ Time Frame: 4 years - Median follow up time of 45.3 months ]

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2. Secondary:

Toxicity [ Time Frame: 4 years ]

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Serious Adverse Events

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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
This study was terminated early due to slow accrual. 4 patients withdrew from the study due to side-effects from the treatment. All 9 patients were evaluable for toxicity and PFS.

Results Point of Contact:

Name/Title: J. MIchael Straughn, MD
Organization: UAB
phone: 205-934-4986
e-mail: Michael.Straughn@ccc.uab.edu

No publications provided

Responsible Party:	J. Michael Straughn, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00584909 History of Changes
Other Study ID Numbers:	F060328016 (UAB 0604), UAB 0604
Study First Received:	December 21, 2007
Results First Received:	September 21, 2011
Last Updated:	February 28, 2012
Health Authority:	United States: Food and Drug Administration

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