Megestrol Acetate for Endometrial Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Endometrial Cancer+1 MoreMegestrol Acetate - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is testing megestrol acetate, with or without pterostilbene, to see if it can treat endometrial cancer.

Eligible Conditions
  • Endometrial Cancer
  • Endometrial Atypical Hyperplasia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 6 weeks

Week 6
Neoplasms
Immunohistochemical expression of Casp3 to assess tumor growth and apoptosis
Tumor Ki-67 proliferation index
Up to 6 weeks
Histologic response of eosinophilic cytoplasm
Histologic response of gland cellularity
Primary Myelofibrosis
Antimitotic Agents

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Megestrol Acetate
57%Hemorrhage, GU: Vagina
30%Weight gain
23%Pain: Abdomen NOS
23%Pain: Head/headache
23%Nausea
23%Fatigue (asthenia, lethargy, malaise)
17%Distension/bloating, abdominal
17%Mood alteration: Depression
13%Insomnia
13%Urinary frequency/urgency
13%Dyspnea (shortness of breath)
13%Gastrointestinal - Other: Increased Appetite
10%Neuropathy: sensory
10%Hot flashes/flushes
10%Constipation
10%Constitutional Symptoms - Other: thirst
10%Mood alteration: Anxiety
10%Pain: Back
7%Pain: Chest/thorax NOS
7%Sweating (diaphoresis)
7%Vaginal discharge (non-infectious)
7%Pain - Other: side of body
7%Pain: Throat/pharynx/larynx
7%Dry skin
7%Hypertension
3%Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
3%Rigors/chills
3%Pain: Muscle
3%Rash: acne/acneiform
3%Pain: Pain NOS
3%Pruritus/itching
3%Dermatology/Skin - Other: blister
3%Dysphagia (difficulty swallowing)
3%Musculoskeletal/Soft Tissue - Other: Spasm
3%Pain: Neuralgia/peripheral nerve
3%Edema: head and neck:
3%pain: stomach
3%Neuropathy: cranial: CN V Motor-jaw muscles; Sensory-facial
3%Hypotension
3%Cystitis
3%Dermatology/Skin - Other: skin peeling
3%Odor (patient odor)
3%Pain: Pelvis
3%Flushing
3%Diarrhea
3%Muscle weakness, generalized or specific area (not due to neuropathy): Whole body/generalized
3%Proteinuria
3%Rash/desquamation
3%Pain: Extremity-limb
3%Renal/Genitourinary - Other: Burning With Urination
3%Thrombosis/thrombus/embolism
3%Glucose, serum-low (hypoglycemia)
3%Pain: Pleura
3%Pain: Vagina
3%Urticaria (hives, welts, wheals)
3%Vomiting
3%Irregular menses (change from baseline)
3%Memory impairment
3%Libido
3%Mood alteration: Agitation
3%Anorexia
3%Allergic reaction/hypersensitivity (including drug fever)
3%Dizziness
3%Flatulence
3%Flu-like syndrome
3%Confusion
3%Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
This histogram enumerates side effects from a completed 2013 Phase 2 trial (NCT00483327) in the Megestrol Acetate ARM group. Side effects include: Hemorrhage, GU: Vagina with 57%, Weight gain with 30%, Pain: Abdomen NOS with 23%, Pain: Head/headache with 23%, Nausea with 23%.

Trial Design

2 Treatment Groups

Arm II (megestrol acetate)
1 of 2
Arm I (pterostilbene, megestrol acetate)
1 of 2

Experimental Treatment

28 Total Participants · 2 Treatment Groups

Primary Treatment: Megestrol Acetate · No Placebo Group · Phase 2

Arm II (megestrol acetate)
Drug
Experimental Group · 1 Intervention: Megestrol Acetate · Intervention Types: Drug
Arm I (pterostilbene, megestrol acetate)Experimental Group · 2 Interventions: Pterostilbene, Megestrol Acetate · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Megestrol acetate
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 weeks

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,073 Previous Clinical Trials
41,138,890 Total Patients Enrolled
70 Trials studying Endometrial Cancer
70,467 Patients Enrolled for Endometrial Cancer
City of Hope Medical CenterLead Sponsor
515 Previous Clinical Trials
2,248,052 Total Patients Enrolled
Thanh H DellingerPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
49 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have provided informed consent of the participant and/or legally authorized representative.
You have a performance status of 0-2.
You have a histologically confirmed EC or complex atypical hyperplasia of the endometrium.
You are about to initiate preoperative window period, with planned hysterectomy scheduled.
Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement.