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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2003 (estimated)
  2. Study startNov 1999
  3. Study completionSep 2007

Resources

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)
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

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.

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