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Monoclonal Antibodies
Chemotherapy Combinations for Endometrial Cancer
Phase 2
Waitlist Available
Led By Carol Aghajanian
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fasting triglycerides =< 2.5 x ULN (CTCAE v3.0 grade 1)
Histologic confirmation of the original primary tumor is required; eligible histologic epithelial cell types include endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from date of study entry to time of death or the date of last contact, assessed up to 5 years
Awards & highlights
Study Summary
This trial is testing three different combination chemotherapy regimens to treat endometrial cancer.
Who is the study for?
This trial is for adults with advanced (stage III/IV) or recurrent endometrial cancer. Eligible participants may have had hormonal therapy but must not have received chemotherapy, targeted therapy, or radiation outside of specific criteria. They should have a certain level of blood cells and organ function, no serious wounds or bleeding risks, controlled seizures if present, stable heart conditions without recent severe events, and no known allergies to certain biologic drugs.Check my eligibility
What is being tested?
The study compares three treatment combinations: Paclitaxel with Carboplatin and Bevacizumab; Paclitaxel with Carboplatin and Temsirolimus; Ixabepilone with Carboplatin and Bevacizumab. It aims to find out which regimen is most effective in stopping tumor growth by killing the cells or preventing them from dividing.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used, increased risk of infection due to lowered blood cell counts, potential bleeding issues related to Bevacizumab use, nerve damage that could cause pain or numbness (neuropathy), as well as general symptoms like fatigue and digestive problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My fasting triglyceride levels are within normal limits.
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My cancer is confirmed and is one of the specified types like endometrioid or serous adenocarcinoma.
Select...
I can take care of myself but might not be able to do heavy physical work.
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My kidney function, measured by creatinine, is within the normal range.
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My fasting cholesterol is below 300 mg/dL.
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My endometrial cancer is at a late stage or has come back.
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My white blood cell count is healthy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from date of study entry to time of death or the date of last contact, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from date of study entry to time of death or the date of last contact, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Who Progressed or Died by 25 Months From Enrollment
Secondary outcome measures
Frequency and Severity of Toxicity as Assessed by CTCAE v3.0 for Each of the Three Arms.
The Median Duration of Overall Survival for Each of the Three Arms.
The Proportion of Patients With Measurable Disease Who Have Confirmed Objective Tumor Responses by Treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm III (ixabepilone, carboplatin, bevacizumab)Experimental Treatment4 Interventions
Patients receive ixabepilone IV over 1 hour, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (paclitaxel, carboplatin, temsirolimus)Experimental Treatment4 Interventions
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and temsirolimus IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Group III: Arm I (paclitaxel, carboplatin, bevacizumab)Experimental Treatment4 Interventions
Patients receive paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Carboplatin
2014
Completed Phase 3
~6670
Ixabepilone
2006
Completed Phase 3
~2270
Paclitaxel
2011
Completed Phase 4
~5380
Temsirolimus
2008
Completed Phase 2
~1940
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,804 Total Patients Enrolled
18 Trials studying Endometrial Carcinoma
8,838 Patients Enrolled for Endometrial Carcinoma
NRG OncologyOTHER
231 Previous Clinical Trials
100,503 Total Patients Enrolled
3 Trials studying Endometrial Carcinoma
223 Patients Enrolled for Endometrial Carcinoma
Carol AghajanianPrincipal InvestigatorNRG Oncology
3 Previous Clinical Trials
1,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chemotherapy for a tumor in my abdomen or pelvis in the last 3 years.I do not have a history of brain or spinal cord diseases.I have not undergone any major surgeries recently.My fasting triglyceride levels are within normal limits.I do not have any non-healing wounds, ulcers, or bone fractures.I do not have lung inflammation, low oxygen levels, or difficulty breathing.I haven't had any other cancer besides this one in the last 3 years.I have had radiation therapy to my abdomen or pelvis in the last 3 years.I do not have any current bleeding or conditions that increase my risk of bleeding.I do not have any major heart conditions.My diabetes is not under control and my HgbA1C level is above 8.My cancer is confirmed and is one of the specified types like endometrioid or serous adenocarcinoma.I can take care of myself but might not be able to do heavy physical work.My fasting cholesterol is below 300 mg/dL.I do not have severe numbness or pain in my hands or feet.My endometrial cancer is at a late stage or has come back.My white blood cell count is healthy.I have not been excluded from receiving chemotherapy or targeted therapy.My kidney function, measured by creatinine, is within the normal range.I meet the specific requirements for radiation and hormonal therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (paclitaxel, carboplatin, bevacizumab)
- Group 2: Arm II (paclitaxel, carboplatin, temsirolimus)
- Group 3: Arm III (ixabepilone, carboplatin, bevacizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a heightened risk associated with Bevacizumab?
"While Phase 2 trials don't have the same level of efficacy data as Phase 3, this medication did show some signs of safety in earlier testing. Bevacizumab received a score of 2."
Answered by AI
Is this research being conducted in numerous hospitals in the city?
"So far, this study has 100 enrollees from locations such as University of Missouri - Ellis Fischel in Columbia, Vince Lombardi Cancer Clinic-Sheboygan in Sheboygan, and Michiana Hematology Oncology PC-Elkhart in Elkhart. There are also another 100 enrollees spread out across different medical centres."
Answered by AI
What are Bevacizumab's most common applications in medical treatment?
"Bevacizumab is generally used as a first line of treatment. This medication can also be effective in treating other conditions such as metastatic bladder cancer, stiff shoulder, and advanced testicular cancer."
Answered by AI
Are we still looking for participants in this experiment?
"This particular trial is not enrolling patients at the moment. The study was first made public on September 14th, 2009 and updated for the last time on September 23rd, 2022. If you are interested in alternative trials, there are 2093 endometrial neoplasms studies and 1672 Bevacizumab clinical trials that are still admitting participants."
Answered by AI
Can you tell me about any other times Bevacizumab has been used in clinical trials?
"In 1997, Bevacizumab was first trialed at City of Hope Comprehensive Cancer Center. Since then, there have been 3344 completed trials with 1672 more presently underway. Many of these active clinical trials are based in Columbia, Missouri."
Answered by AI
How many willing participants are needed for this research project?
"This specific trial is not enrolling patients at the moment, however, there are 2093 studies for endometrial neoplasms and 1672 trials involving Bevacizumab that are. The original posting for this trial was on September 14th, 2009 with the most recent update being from September 23rd, 2022."
Answered by AI
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