Tirzepatide for Endometrial Cancer

Recruiting at 6 trial locations

Overseen By Angela Green, MD

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Tirzepatide, Semaglutide

Must not be taking: GIP/GLP-1 agonists

Disqualifiers: Type 1 diabetes, Pancreatitis, others

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

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tirzepatide, a medication for managing weight and blood sugar, and possibly semaglutide, can help manage these factors in patients with endometrial cancer undergoing chemotherapy. The study also examines the drug's safety and its effects on weight, body fat, and blood pressure. It suits adults who recently had surgery for stage I-III endometrial cancer and are beginning chemotherapy, particularly those with obesity or type 2 diabetes. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to contribute to groundbreaking research.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are currently using GIP/GLP-1 or GLP-1 receptor agonists, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tirzepatide is generally safe for people. Many clinical studies have confirmed its safety, and any side effects can be managed. Importantly, a large study with over 10,000 participants found no link between tirzepatide and cancer. Additionally, when assessing cancer risk, tirzepatide was similar to other treatments, indicating it doesn't pose extra danger. Overall, most people tolerate tirzepatide well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for endometrial cancer, which typically involve surgery, radiation, or chemotherapy, tirzepatide offers a novel approach by targeting metabolic pathways. This drug is a GLP-1 receptor agonist, originally used for managing diabetes, which can also influence cancer growth by affecting insulin levels and weight management. Researchers are excited about tirzepatide because it not only has the potential to inhibit cancer progression but also offers a new mechanism of action that could complement or enhance current treatment strategies.

What evidence suggests that tirzepatide might be an effective treatment for endometrial cancer?

Studies have shown that tirzepatide can help reduce body weight by affecting how the body processes sugars and fats. One study found that tirzepatide significantly reduced tumor size by over 60% in some groups. Additionally, tirzepatide has been linked to significant weight loss, with some patients losing up to 22.9% of their body weight over several years. These findings suggest that tirzepatide might be useful for managing weight and possibly slowing cancer growth in patients with endometrial cancer. Participants in this trial will receive tirzepatide, and if insurance does not cover it, the GLP-1 agonist semaglutide may be substituted if deemed appropriate by the study PI. ^{1 2 3 6 7}

Who Is on the Research Team?

Angela Green, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with endometrial cancer who are experiencing severe weight loss. Participants should be undergoing chemotherapy and interested in managing their weight and blood sugar levels.

Inclusion Criteria

My cancer is one of the specified types of epithelial cell cancer.

I can take care of myself but might not be able to do heavy physical work.

I had surgery to remove my uterus/ovaries and no visible cancer remains.

Exclusion Criteria

I have a history of delayed stomach emptying.

I haven't had obesity treatments like surgery or devices in the last 2 years.

I have Type 1 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive tirzepatide or semaglutide for weight management and blood sugar control during chemotherapy

24 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue treatment for up to 1 year to assess long-term effects

28 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The study is testing the effectiveness of tirzepatide, a medication, on weight management and blood sugar control in patients with endometrial cancer during chemotherapy treatment.

How Is the Trial Designed?

Group I: tirzepatide Experimental Treatment 1 Intervention

Patients will meet with the study endocrinologist during screening and be prescribed SC tirzepatide 2.5 mg administered using a pre-filled injector once weekly for 4 weeks and then increase to 5 mg once weekly. If insurance does not cover tirzepatide, the GLP-1 agonist semaglutide (Wegovy, Ozempic) initiated at 0.25 mg weekly SC may be substituted if deemed appropriate by the study PI.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Oral etoposide was well tolerated in a study of 44 women with metastatic endometrial cancer, with only a few experiencing significant side effects, indicating its safety as a treatment option.

The treatment showed a modest efficacy, with a 14% response rate (1 complete and 5 partial responses), suggesting that while it may not be highly effective alone, its low toxicity makes it a potential candidate for combination therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II trial of oral etoposide in recurrent or refractory endometrial adenocarcinoma: a southwest oncology group study. Poplin, EA., Liu, PY., Delmore, JE., et al.[2013]

Ixabepilone, a microtubule-stabilizing agent approved for metastatic breast cancer, has been evaluated for its potential effectiveness in treating advanced or recurrent endometrial cancer, but its role remains unclear.

Despite some preclinical and clinical studies, ixabepilone has shown limited efficacy in endometrial cancer, highlighting the ongoing need for more effective treatment strategies in this challenging area of gynecological malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ixabepilone for the treatment of endometrial cancer. Marchetti, C., Piacenti, I., Imperiale, L., et al.[2016]

In a study of 48 patients with high-risk stage III and IV endometrial cancer, the combination of paclitaxel and carboplatin (TC) after complete tumor resection resulted in a 3-year overall survival rate of 56% and a median overall survival of 47 months.

The treatment was well tolerated, with 90% of patients completing all planned cycles, and a median time to disease progression of 13 months, indicating that TC is an effective option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel and carboplatin in the adjuvant treatment of patients with high-risk stage III and IV endometrial cancer: a retrospective study. Sovak, MA., Hensley, ML., Dupont, J., et al.[2015]

In a phase 2 trial involving 39 patients with advanced or recurrent endometrial cancer, the combination of nonpegylated doxorubicin citrate and carboplatin showed a response rate of 44%, with 1 complete response and 16 partial responses, indicating significant efficacy in this patient population.

The median progression-free survival was 7.2 months and median overall survival was 14.7 months, with manageable toxicity; however, 17% of patients experienced grade 3/4 neutropenia, highlighting the need for monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carboplatin and nonpegylated liposomal doxorubicin in primary advanced or recurrent endometrial cancer: a phase 2 trial conducted by AGO Austria. Volgger, B., Zeimet, AG., Reinthaller, A., et al.[2018]

In a phase III study involving 496 women with advanced endometrial cancer, ixabepilone did not improve overall survival compared to standard chemotherapy (doxorubicin or paclitaxel), leading to the study's discontinuation based on interim results.

The safety profiles of ixabepilone and the control treatments were comparable, indicating that while ixabepilone was not more effective, it also did not present additional safety concerns compared to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. McMeekin, S., Dizon, D., Barter, J., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12593436/

Tirzepatide for fertility-sparing treatment in obese/overweight ... Further analysis revealed that tirzepatide effectively alters the host and tumour environment, reducing body weight by modulating glycolysis, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07065552

Tirzepatide in Obesity-Driven Endometrial Cancer The primary objective is to determine if tirzepatide decreases proliferation in the tumors of EC patients. The effect of tirzepatide on the endometrium of 20 ...

3. gynecologiconcology-online.net gynecologiconcology-online.net/article/S0090-8258(24)01154-5/fulltext

Tirzepatide as an innovative treatment strategy in a pre- ... Treatment with tirzepatide for 4 weeks significantly reduced tumor weight by 66.4 % and 60.1 % in the HFD- and LFD-fed groups, respectively (Fig ...

4. e-enm.org e-enm.org/journal/view.php?number=2572

Tirzepatide and Cancer Risk in Individuals with and without ... A recent meta-analysis, which included data from 37 RCTs and 19 real-world studies, reported no increased risk of any cancer with semaglutide ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2416394

Tirzepatide as Compared with Semaglutide for ... Clinically meaningful weight reductions occur with both medications, with reported mean weight reductions of up to 22.9% after nearly 3.5 years ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0090825824011545

Tirzepatide as an innovative treatment strategy in a pre- ... Numerous clinical studies have consistently demonstrated that tirzepatide exhibits a favorable safety profile, manageable adverse effects and a unique ability ...

7. fellahealth.com fellahealth.com/guide/is-tirzepatide-linked-to-cancer

Is Tirzepatide Linked to Cancer? FDA Safety Data and ... As of 2024, no established causal link exists between tirzepatide and cancer development in humans. Clinical trials involving over 10,000 participants showed no ...