Tirzepatide for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen by Angela Green, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

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

Trial Summary

What is the purpose of this trial?

The researchers are doing this study is to find out whether tirzepatide and semaglutide are practical (feasible) for weight management and blood sugar control for endometrial cancer patients undergoing chemotherapy. The researchers will also look at participants' experience with the study drug, the safety of taking the study drug while receiving chemotherapy, and changes in weight, body fat composition, and blood pressure of participants.

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.

How is the drug Tirzepatide unique for treating endometrial cancer?

Tirzepatide is unique because it is primarily known for treating type 2 diabetes by mimicking hormones that regulate blood sugar and appetite, which is different from traditional chemotherapy drugs used for endometrial cancer. This novel approach could offer a new mechanism of action compared to existing treatments. ^{1 2 3 4 5}

Research Team

Angela Green, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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 am 18 years old or older.

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

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.

Trial Timeline

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

Treatment Details

Interventions

• Tirzepatide (GLP-1 Receptor Agonist)

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.

Participant Groups

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+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Findings from Research

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 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 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]

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]

References

1. England 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. [2018]

2. United States 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. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Phase II trial of oral etoposide in recurrent or refractory endometrial adenocarcinoma: a southwest oncology group study. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Ixabepilone for the treatment of endometrial cancer. [2016]