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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00023894




Registration number
NCT00023894
Ethics application status
Date submitted
13/09/2001
Date registered
27/01/2003
Date last updated
24/06/2013

Titles & IDs
Public title
Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
Scientific title
A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Secondary ID [1] 0 0
GOG-0129M
Secondary ID [2] 0 0
CDR0000068874
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
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 primary endometrial carcinoma

* Recurrent or persistent disease
* Refractory to curative therapy or established treatment
* Previously treated with only 1 prior cytotoxic chemotherapy regimen (either single agent or combination therapy) for endometrial carcinoma

* Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
* At least 1 unidimensionally measurable lesion

* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* At least 1 target lesion outside previously irradiated field
* Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol, defined as any active GOG phase III protocol for the same patient population

PATIENT CHARACTERISTICS:

Age:

* Any age

Performance status:

* GOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

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

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* PT/PTT normal

Renal:

* Creatinine no greater than 1.5 times ULN

Cardiovascular:

* No prior thromboembolic events or thrombophlebitis
* No prior recent myocardial infarction
* No prior angina
* No prior cerebrovascular accident
* No prior transient ischemic attacks

Other:

* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No grade 2 or greater sensory or motor neuropathy
* No active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 3 weeks since prior biologic or immunologic agents for endometrial carcinoma

Chemotherapy:

* See Disease Characteristics
* At least 3 weeks since prior chemotherapy for endometrial carcinoma and recovered

Endocrine therapy:

* At least 1 week since prior hormonal therapy for endometrial carcinoma
* Concurrent hormone replacement therapy allowed

Radiotherapy:

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy for endometrial carcinoma and recovered

Surgery:

* At least 3 weeks since prior surgery for endometrial carcinoma and recovered
* At least 6 months since prior re-vascularization procedures (e.g., coronary artery bypass graft, carotid endarterectomy or bypass, or angioplasty with or without stents)

Other:

* At least 3 weeks since other prior therapy for endometrial carcinoma
* At least 6 months since prior thrombolytic procedures
* No prior cyclin-dependent kinase inhibitors
* No prior anticancer therapy that would preclude study
* 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
Blinded (masking 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
1/07/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2006
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
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United States of America
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California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Illinois
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Indiana
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United States of America
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Iowa
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United States of America
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Kentucky
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United States of America
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Maryland
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Massachusetts
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Minnesota
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Mississippi
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Vermont
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United States of America
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Virginia
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United States of America
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Washington
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Canada
State/province [27] 0 0
Alberta
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Norway
State/province [28] 0 0
Oslo
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United Kingdom
State/province [29] 0 0
England

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 use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or persistent endometrial cancer.
Trial website
https://clinicaltrials.gov/study/NCT00023894
Trial related presentations / publications
Grendys EC Jr, Blessing JA, Burger R, Hoffman J. A phase II evaluation of flavopiridol as second-line chemotherapy of endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Aug;98(2):249-53. doi: 10.1016/j.ygyno.2005.05.017.
Public notes

Contacts
Principal investigator
Name 0 0
Edward C. Grendys, MD
Address 0 0
Robert H. Lurie Cancer Center
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/NCT00023894