Progestins for Endometrial Cancer

Not yet recruiting at 3 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: New Mexico Cancer Research Alliance

Must not be taking: Progestins, Anti-estrogens

Disqualifiers: Non-endometrioid histology, Thrombosis, Peanut allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 3-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial tests compares the effect of progestins, megestrol acetate to micronized progesterone, in treating patients with endometrial cancer and precancers of the uterus (atypical endometrial hyperplasia) before surgery. Progestins, similar to the natural hormone progesterone, are approved drugs used in birth control and hormone replacement pills, and some can treat uterine endometrial cancers. In the initial comparison of this rotating umbrella trial, megestrol acetate, a progestin, will be compared to micronized progesterone, a form of natural progesterone that is a hormone produced by body normally. Hormone therapy using megestrol acetate and micronized progesterone may be effective in treating patients with endometrial cancer or atypical endometrial hyperplasia before surgery, and understanding the tissue effects of each agent on the malignant endometrium will uncover novel mechanistic and biomarker data to understand how best to advanced hormone therapy for endometrial cancer.

Who Is on the Research Team?

Carolyn Y Muller

Principal Investigator

University of New Mexico Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

* Platelets ≥ 100,000/μl

I was diagnosed with endometrioid endometrial cancer by biopsy within the last 8 weeks.

I have tumor tissue samples and a pathology report available from my biopsy or curettage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either megestrol acetate or micronized progesterone for 21-24 days before surgery

3-4 weeks

1 visit (in-person) for biopsy or curettage

Surgery

Participants undergo standard of care hysterectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4-6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Megestrol Acetate
• Progesterone Only Hormone Replacement Therapy

How Is the Trial Designed?

Group I: Arm II (biopsy, curettage, progesterone, hysterectomy) Experimental Treatment 4 Interventions

Patients undergo biopsy or curettage and then receive micronized progesterone PO QD beginning 21-24 days prior to SOC hysterectomy on study.

Group II: Arm I (biopsy, curettage, MPA, hysterectomy) Active Control 4 Interventions

Patients undergo biopsy or curettage and then receive megestrol acetate PO BID 21-24 days prior to SOC hysterectomy on study.

Who Is Running the Clinical Trial?

New Mexico Cancer Research Alliance

Lead Sponsor

Trials

71

Recruited

52,500+

University of New Mexico Cancer Center

Collaborator

Trials

7

Recruited

160+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+