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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more
Other outcome measures
Expression of MATE 2
Incidence of PIK3 Mutations/Amplifications
Levels of Key Targets of the Metformin/mTOR Signaling Pathway
+1 more

Trial 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
70,917 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,952,845 Total Patients Enrolled
Victoria L Bae-JumpPrincipal InvestigatorNRG Oncology

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02065687 — Phase 2 & 3
Endometrial Adenocarcinoma Research Study Groups: Arm I (paclitaxel, carboplatin, metformin hydrochloride), Arm II (paclitaxel, carboplatin, placebo)
Endometrial Adenocarcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02065687 — Phase 2 & 3
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02065687 — Phase 2 & 3
~42 spots leftby Jun 2025
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