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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00085332




Registration number
NCT00085332
Ethics application status
Date submitted
10/06/2004
Date registered
11/06/2004
Date last updated
13/01/2014

Titles & IDs
Public title
Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)
Scientific title
A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Secondary ID [1] 0 0
CDR0000368634
Secondary ID [2] 0 0
GOG-0129N
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed endometrial carcinoma

* Recurrent or persistent disease
* Refractory to curative or standard therapy
* Measurable disease

* At least 1 unidimensionally measurable lesion = 20 mm by conventional techniques OR = 10 mm by spiral CT scan
* At least 1 target lesion

* Tumors within a previously irradiated field are not considered target lesions
* Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment

* One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
* Ineligible for a higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age

* Any age

Performance status

* GOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count = 1,500/mm^3
* Platelet count = 100,000/mm^3

Hepatic

* SGOT = 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase = 2.5 times ULN
* Bilirubin = 1.5 times ULN

Renal

* Creatinine = 1.5 times ULN

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No neuropathy (sensory and motor) = grade 2
* No active infection requiring antibiotics
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
* At least 3 weeks since prior biologic or immunologic therapy for malignant tumor
* No concurrent prophylactic growth factors
* No concurrent prophylactic thrombopoietic agents

Chemotherapy

* See Disease Characteristics
* Recovered from prior chemotherapy
* No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs)

Endocrine therapy

* At least 1 week since prior hormonal therapy for malignant tumor
* Concurrent hormone replacement therapy allowed

Radiotherapy

* See Disease Characteristics
* Recovered from prior radiotherapy

Surgery

* Recovered from prior surgery

Other

* At least 3 weeks since other prior therapy for malignant tumor
* No prior anticancer therapy that would preclude current protocol therapy
* No concurrent amifostine or other protective reagents
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Australia New Zealand Gynaecological Oncology Trials Group - Camperdown
Recruitment postcode(s) [1] 0 0
1450 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Vermont
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Japan
State/province [34] 0 0
Kagoshima City
Country [35] 0 0
Norway
State/province [35] 0 0
Oslo

Funding & Sponsors
Primary sponsor type
Other
Name
Gynecologic Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).
Trial website
https://clinicaltrials.gov/study/NCT00085332
Trial related presentations / publications
Garcia AA, Blessing JA, Nolte S, Mannel RS; Gynecologic Oncology Group. A phase II evaluation of weekly docetaxel in the treatment of recurrent or persistent endometrial carcinoma: a study by the Gynecologic Oncology Group. Gynecol Oncol. 2008 Oct;111(1):22-6. doi: 10.1016/j.ygyno.2008.06.013.
Public notes

Contacts
Principal investigator
Name 0 0
Agustin Garcia, MD
Address 0 0
Premiere Oncology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00085332