Endometrial CancerPhase 2NCT00071929
Oxaliplatin in Treating Patients With Persistent or Recurrent Endometrial Cancer
A Phase 2 study testing oxaliplatin in people with Endometrial Cancer, run by Gynecologic Oncology Group at 38 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- oxaliplatin
- How many people
- Not given
- Where
- 38 sitesUnited States
- Study dates
- Nov 1999to Sep 2007
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed endometrial carcinoma that is refractory to curative therapy or established treatment
- Clinically and/or histologically confirmed persistent or recurrent disease
- Measurable disease by physical examination or medical imaging
- Sonography allowed if lesions are clearly defined on initial examination and bidimensionally measurable
- Ascites or pleural effusions not considered measurable
- Must have received 1 prior cytotoxic therapy regimen
- May include high-dose therapy, consolidation, or extended therapy after surgical or nonsurgical assessment
- 1 additional noncytotoxic regimen allowed
- Biologic or cytostatic agents include, but are not limited to:
- Monoclonal antibodies
- Cytokines
- Small-molecule inhibitors of signal transduction
- Ineligible for a higher priority GOG protocol
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2 if received 1 prior therapy regimen
- GOG 0-1 if received 2 prior therapy regimens
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
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Neurologic
- No sensory or motor neuropathy greater than grade 1
- No residual neuropathy attributed to prior chemotherapy or other chronic conditions (e.g., diabetes, venous stasis, or carpal tunnel syndrome)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergy to platinum compounds or antiemetics
- No active infection requiring antibiotics
- No other uncontrolled illness
- No other invasive malignancies within the past 5 years except nonmelanomatous skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 14 days since prior pegfilgrastim
- At least 24 hours since other prior growth factors
- At least 3 weeks since prior biologic or immunologic therapy
- No concurrent growth factors during first course of study therapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy and recovered
- No more than 1 prior cytotoxic chemotherapy regimen, either single or combination cytotoxic drug therapy
- No prior oxaliplatin
Endocrine therapy
- At least 1 week since prior hormonal therapy directed at tumor
- Concurrent hormone replacement therapy allowed
Radiotherapy
- At least 4 weeks since prior radiotherapy and recovered
Surgery
- Recovered from any recent surgery
Other
- At least 3 weeks since prior therapy for endometrial cancer
- No other concurrent investigational agents
- No prior anticancer therapy that would preclude study participation
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
SUNY Downstate Medical Center
Brooklyn, New York, 11203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Ireland Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44124
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
Mount Carmel West Hospital
Columbus, Ohio, 43222
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
CCOP - Central Illinois
Decatur, Illinois, 62794-9640
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010
CCOP - Evanston
Evanston, Illinois, 60201
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
CCOP - Kansas City
Kansas City, Missouri, 64131
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, 37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, 37232-2516
New Britain General Hospital
New Britain, Connecticut, 06052
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213-3180
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, 11790-7775
CCOP - Scott and White Hospital
Temple, Texas, 76508
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
About this study
Official title: Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.
Read the detailed description
OBJECTIVES:
- Determine the antitumor activity of oxaliplatin in terms of response rate in patients with persistent or recurrent endometrial carcinoma that is refractory to curative or established therapy.
- Determine the nature and degree of toxicity of this treatment regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.
- Conditions
- Endometrial Cancer
- Being tested
- oxaliplatin
- 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.
oxaliplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2003 (estimated)
- Study startNov 1999
- Study completionSep 2007
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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Paula M. Fracasso, MD, PhD, Study chair, Washington University Siteman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071929
- Sponsor's protocol ID
- CDR0000068235
- Other IDs
- GOG-0129K
- Status last verified
- Sep 2004
- First submitted
- 4 Nov 2003
- Last updated
- 24 Jun 2013
- Results posted
- No
Publications
Fracasso PM, Blessing JA, Molpus KL, Adler LM, Sorosky JI, Rose PG. Phase II study of oxaliplatin as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Nov;103(2):523-6. doi: 10.1016/j.ygyno.2006.03.043. Epub 2006 May 19.
PubMed 16712905
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
- Phase II Evaluation of Oxaliplatin in the Treatment of Recurrent or Persistent Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00071929
- Acronym / sponsor ID
- CDR0000068235
- 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
- Nov 1999
- Study completion
- Sep 2007 (actual)
- First posted
- 6 Nov 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, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have persistent or recurrent endometrial cancer.
Detailed description
OBJECTIVES:
- Determine the antitumor activity of oxaliplatin in terms of response rate in patients with persistent or recurrent endometrial carcinoma that is refractory to curative or established therapy.
- Determine the nature and degree of toxicity of this treatment regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: Approximately 19-51 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| oxaliplatin | 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 16712905Fracasso PM, Blessing JA, Molpus KL, Adler LM, Sorosky JI, Rose PG. Phase II study of oxaliplatin as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2006 Nov;103(2):523-6. doi: 10.1016/j.ygyno.2006.03.043. Epub 2006 May 19.
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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.
Paula M. Fracasso, MD, PhD study chair
Washington University Siteman Cancer Center
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing oxaliplatin in people with Endometrial Cancer, run by Gynecologic Oncology Group at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
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 38 sites in United States. 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 NCT00071929, 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.