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Alkylating agents
Questionnaire Administration for Endometrial Adenocarcinoma
Phase 2 & 3
Waitlist Available
Led By Victoria L Bae-Jump
Research Sponsored by Gynecologic Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether paclitaxel, carboplatin, and metformin hydrochloride is more effective than paclitaxel, carboplatin, and placebo in treating endometrial cancer.
Eligible Conditions
- Endometrial Adenocarcinoma
- Uterine Cancer
- Uterine Corpus Cancer
- Endometrial Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Overall Survival (OS) (Phase II and III)
Progression-free Survival (PFS) (Phase II)
Secondary outcome measures
Duration of Response by Treatment
Level of Obesity
Number of Participants With Grade 3 or Higher Adverse Events as Assessed by Common Terminology Criteria for Adverse Events Version 4
+3 moreOther outcome measures
Expression of MATE 2
Incidence of PIK3 Mutations/Amplifications
Levels of Key Targets of the Metformin/mTOR Signaling Pathway
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (paclitaxel, carboplatin, metformin hydrochloride)Experimental Treatment6 Interventions
Patients receive paclitaxel IV over 3 hours on day 1, carboplatin IV over 30 minutes on day 1, and metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
In both arms, patients who achieve SD or PR and still have measurable disease at the completion of course 6 may continue to receive paclitaxel IV and carboplatin IV (with metformin hydrochloride or placebo) for an additional 4 courses at the discretion of the treating investigator.
Group II: Arm II (paclitaxel, carboplatin, placebo)Active Control6 Interventions
Patients receive paclitaxel IV and carboplatin IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
In both arms, patients who achieve SD or PR and still have measurable disease at the completion of course 6 may continue to receive paclitaxel IV and carboplatin IV (with metformin hydrochloride or placebo) for an additional 4 courses at the discretion of the treating investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Paclitaxel
FDA approved
Metformin
FDA approved
Find a Location
Who is running the clinical trial?
Gynecologic Oncology GroupLead Sponsor
250 Previous Clinical Trials
70,457 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,932,684 Total Patients Enrolled
Victoria L Bae-JumpPrincipal InvestigatorNRG Oncology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a health condition or habits that may increase the risk of a serious side effect called metformin-associated lactic acidosis. This includes having severe congestive heart failure or a history of certain types of acidosis, or regularly drinking three or more alcoholic beverages per day.You have not received chemotherapy or targeted therapy before for treating endometrial carcinoma.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (paclitaxel, carboplatin, placebo)
- Group 2: Arm I (paclitaxel, carboplatin, metformin hydrochloride)
Awards:
This trial has 2 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
In how many total locations is this research being conducted?
"There are 100 medical facilities enrolling patients in this clinical trial, such as Fairview-Southdale Hospital in Edina, Marshfield Clinic - Weston Center in Weston, and Novant Health Oncology Specialists-Statesville in Statesville."
Answered by AI
Has there been any previous research completed through administering surveys?
"Questionnaire Administration was first researched in 1997 at City of Hope Comprehensive Cancer Center. So far, 3297 studies have been completed. Presently, there are 1402 studies in progress with a large number of them taking place in Edina, Minnesota."
Answered by AI
What medical conditions are helped by the use of Questionnaire Administration?
"Although it is most often used in palliative care, questionnaire administration can also be used to treat things like malignant peritoneal neoplasm, advanced endometrial cancer, and melanoma."
Answered by AI
Can people with the required qualifications join this trial right now?
"Unfortunately, this clinical trial is not presently looking for candidates. Although, it is worth noting that the study was last edited on September 28th, 2021. If you are exploring other studies, there are presently 4212 trials actively looking for participants with cystadenocarcinoma, serous and 1402 studies for Questionnaire Administration actively recruiting patients."
Answered by AI
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