Endometrial CancerPhase 2NCT00005861
Liposomal Doxorubicin in Treating Patients With Advanced or Recurrent Endometrial Cancer
A Phase 2 study testing pegylated liposomal doxorubicin hydrochloride in people with Endometrial Cancer, run by Gynecologic Oncology Group at 10 sites in United States.
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 liposomal doxorubicin in treating women who have recurrent, stage III, or stage IV 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?
- pegylated liposomal doxorubicin hydrochloride
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- May 2000to Aug 2005
- 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 stage III, IV, or recurrent endometrial carcinoma for which curative radiotherapy or surgery is not an option
- Bidimensionally measurable disease
- Irradiated field as only site allowed if evidence of progression since radiotherapy
PATIENT CHARACTERISTICS:
Age:
- Not specified
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 3 times ULN
- Alkaline phosphatase no greater than 3 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- LVEF normal by cardiac echocardiogram or MUGA
Other:
- No concurrent active infection
- No prior or concurrent malignancy within past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior chemotherapy as radiosensitizer allowed
- No prior chemotherapy for advanced or metastatic disease
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- Recovered from prior radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from prior surgery
Other:
- No prior therapy that would preclude study
- No other concurrent antineoplastic agents
- No other concurrent investigational agents
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
New England Medical Center Hospital
Boston, Massachusetts, 02111
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
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
Brookview Research, Inc.
Nashville, Tennessee, 37203
Chao Family Comprehensive Cancer Center
Orange, California, 92868
Washington University School of Medicine
St Louis, Missouri, 63110
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
About this study
Official title: Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent 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 liposomal doxorubicin in treating women who have recurrent, stage III, or stage IV endometrial cancer.
Read the detailed description
OBJECTIVES:
- Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer.
- Determine the response rate, response duration, and overall survival of these patients treated with this regimen.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Courses repeat every 4 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: A total of 19-51 patients will be accrued for this study.
- Conditions
- Endometrial Cancer
- Being tested
- pegylated liposomal doxorubicin hydrochloride
- Keywords
- stage III endometrial carcinoma, stage IV endometrial carcinoma, 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.
pegylated liposomal doxorubicin hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2003 (estimated)
- Study startMay 2000
- Primary completionAug 2005
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
- Howard D. Homesley, MD, Study chair, Gynecologic Oncology NetworkPaula M. Fracasso, MD, PhD, Washington University Siteman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005861
- Sponsor's protocol ID
- CDR0000067891
- Other IDs
- GOG-0086M
- Status last verified
- Aug 2002
- First submitted
- 2 Jun 2000
- Last updated
- 10 Jun 2013
- Results posted
- No
Publications
Homesley HD, Blessing JA, Sorosky J, Reid G, Look KY. Phase II trial of liposomal doxorubicin at 40 mg/m(2) every 4 weeks in endometrial carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2005 Aug;98(2):294-8. doi: 10.1016/j.ygyno.2005.05.016.
PubMed 15975638
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Doxil as First-Line Therapy of Advanced or Recurrent Endometrial Carcinoma
- ClinicalTrials.gov ID
- NCT00005861
- Acronym / sponsor ID
- CDR0000067891
- Conditions
- Endometrial Cancer
- Keywords
- stage III endometrial carcinoma, stage IV endometrial carcinoma, 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
- May 2000
- Primary completion
- Aug 2005 (actual)
- First posted
- 19 May 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 liposomal doxorubicin in treating women who have recurrent, stage III, or stage IV endometrial cancer.
Detailed description
OBJECTIVES:
- Determine the antitumor activity and safety of doxorubicin HCl liposome in patients with advanced or recurrent endometrial cancer.
- Determine the response rate, response duration, and overall survival of these patients treated with this regimen.
OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour. Courses repeat every 4 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: A total of 19-51 patients will be accrued for this study.
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 |
|---|---|---|
| pegylated liposomal doxorubicin hydrochloride | 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 10 Jun 2013.
- Results publication: PubMed 15975638Homesley HD, Blessing JA, Sorosky J, Reid G, Look KY. Phase II trial of liposomal doxorubicin at 40 mg/m(2) every 4 weeks in endometrial carcinoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2005 Aug;98(2):294-8. doi: 10.1016/j.ygyno.2005.05.016.
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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.
Howard D. Homesley, MD study chair
Gynecologic Oncology Network
Paula M. Fracasso, MD, PhD
Washington University Siteman Cancer Center
10 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 pegylated liposomal doxorubicin hydrochloride in people with Endometrial Cancer, run by Gynecologic Oncology Group at 10 sites in United States.
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 10 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 10 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 NCT00005861, 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 10 Jun 2013.