Endometrial CancerPhase 2NCT00023894
Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
A Phase 2 study testing alvocidib in people with Endometrial Cancer, run by Gynecologic Oncology Group at 54 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- alvocidib
- How many people
- Not given
- Where
- 54 sitesin 5 countries
- Study dates
- Jul 2001to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
54 sites in 5 countries.
54 sites in 5 countries
United States50 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
Tuft-New England Medical Center
Boston, Massachusetts, 02111
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103-1489
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Medical University of South Carolina
Charleston, South Carolina, 29425-2233
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3864
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Barrett Cancer Center
Cincinnati, Ohio, 45267-0526
Ireland Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
Simmons Cancer Center - Dallas
Dallas, Texas, 75390-9032
University of Colorado Cancer Center
Denver, Colorado, 80010
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
University of Texas Medical Branch
Galveston, Texas, 77555-0587
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Community Hospital of Los Gatos
Los Gatos, California, 95032
North Shore University Hospital
Manhasset, New York, 11030
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Brookview Research, Inc.
Nashville, Tennessee, 37203
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
Chao Family Comprehensive Cancer Center
Orange, California, 92868
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905-0001
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Washington University School of Medicine
St Louis, Missouri, 63110
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
Tacoma General Hospital
Tacoma, Washington, 98405
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1065
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01605-2982
Australia1 site
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, 1450
United Kingdom1 site
University of Birmingham
Birmingham, England, B15 2TT
About this study
Official title: A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
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.
Read the detailed description
OBJECTIVES:
- Determine the antitumor activity of flavopiridol in patients with recurrent or persistent endometrial carcinoma.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.
- Conditions
- Endometrial Cancer
- Being tested
- alvocidib
- Keywords
- recurrent endometrial carcinoma
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alvocidibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 2001
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Edward C. Grendys, MD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023894
- Sponsor's protocol ID
- CDR0000068874
- Other IDs
- GOG-0129M
- Status last verified
- May 2004
- First submitted
- 13 Sep 2001
- Last updated
- 24 Jun 2013
- Results posted
- No
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.
PubMed 15978659
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00023894
- Acronym / sponsor ID
- CDR0000068874
- Conditions
- Endometrial Cancer
- Keywords
- recurrent endometrial carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2001
- Study completion
- Feb 2006 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Determine the antitumor activity of flavopiridol in patients with recurrent or persistent endometrial carcinoma.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alvocidib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Results publication: PubMed 15978659Grendys 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward C. Grendys, MD study chair
Robert H. Lurie Cancer Center
54 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alvocidib in people with Endometrial Cancer, run by Gynecologic Oncology Group at 54 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Australia, Canada, Norway, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00023894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.