Trabectedin + Doxorubicin for Uterine Leiomyosarcoma

Overseen By Elise Nassif Haddad, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Investigational agents

Disqualifiers: Uncontrolled illness, Allergic reactions, 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: Unknown

Duration: 6 cycles

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining the chemotherapy drugs trabectedin and doxorubicin can help individuals who have undergone surgery to remove uterine leiomyosarcoma remain cancer-free longer. The trial focuses on those with Stage 1b/2 of this cancer who have had their tumors completely removed and have not previously received chemotherapy. It may suit individuals who recently had surgery for uterine leiomyosarcoma, show no remaining cancer on scans, and have not undergone radiation therapy to the pelvic area. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on any other investigational drugs while participating in this trial.

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

Research has shown that using trabectedin and doxorubicin together effectively treats leiomyosarcoma, a cancer that develops in smooth muscle. This treatment has yielded promising results, with 60% of patients experiencing partial improvement and 87% having their disease under control. These figures suggest the treatment effectively manages the disease.

Regarding safety, studies indicate that this combination is generally safe. In past research, patients with advanced uterine leiomyosarcoma tolerated trabectedin well. While some side effects may occur, the overall safety record makes this treatment a viable option for those considering joining a clinical trial. Always discuss potential side effects and concerns with a healthcare provider before participating in any trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for uterine leiomyosarcoma, which often includes surgery, radiation, and chemotherapy regimens like gemcitabine with docetaxel, trabectedin offers a unique approach by targeting the DNA of cancer cells directly. Trabectedin works by binding to the DNA minor groove, interfering with cell division and ultimately leading to cancer cell death. Researchers are excited about this treatment because it has shown potential in overcoming resistance to conventional chemotherapy, offering hope for improved outcomes in patients with this challenging cancer.

What evidence suggests that this treatment might be an effective treatment for uterine leiomyosarcoma?

This trial involves a single treatment arm where participants receive a combination of trabectedin and doxorubicin. Studies have shown that this combination can benefit people with certain cancers, including uterine leiomyosarcoma. Research indicates that using these drugs together can delay cancer's return or worsening. In one study, about 30% of patients treated with this combination were alive without their cancer worsening two years after starting treatment. Another study found that adding trabectedin to doxorubicin helped patients live longer without their cancer worsening. While not every patient will have the same results, these findings suggest the combination could be an effective treatment option. ^{1 3 5 6 7}

Who Is on the Research Team?

Elise Nassif Haddad, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with a type of cancer called Uterine Leiomyosarcoma (uLMS). Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be required to have had no prior treatments that could interfere with the study.

Inclusion Criteria

My uterine sarcoma is at an early but high-risk stage.

My cancer is a confirmed uterine leiomyosarcoma.

My recent scans show no signs of cancer remaining.

Exclusion Criteria

Patients who are receiving any other investigational agents

History of allergic reactions attributed to compounds of similar chemical or biologic composition to doxorubicin or trabectedin or other agents used in study

I am HIV positive, on treatment, and my viral load is undetectable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive adjuvant chemotherapy with doxorubicin and trabectedin for 6 cycles

6 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Doxorubicin
• Trabectedin

Trial Overview The trial is testing the safety and effectiveness of two chemotherapy drugs, Trabectedin and Doxorubicin Hydrochloride. It's unclear how these drugs will be administered or compared in this phase II study.

How Is the Trial Designed?

Group I: Phase II Single Arm Treatment with Doxorubicin and Trabectedin Experimental Treatment 2 Interventions

Participants will receive treatment on an outpatient and standard of care basis

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2403394

Doxorubicin–Trabectedin with Trabectedin Maintenance in ... Combination therapy with doxorubicin and trabectedin induction, followed by trabectedin maintenance, was associated with improved overall survival and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35835135/

a randomised, multicentre, open-label phase 3 trial Doxorubicin plus trabectedin in first-line therapy was found to significantly increase progression-free survival in patients with metastatic or unresectable ...

3. cancer.gov cancer.gov/news-events/cancer-currents-blog/2024/leiomyosarcoma-yondelis-doxorubicin-improve-survival

Trabectedin and Doxorubicin Effective for Leiomyosarcoma Two years after starting treatment, 30% of people in the combination chemotherapy group were alive without their cancer getting worse, compared ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24198180

An Increasing Role for Trabectedin in Gynecological Cancers Thus, the results of phase II studies have shown that treatment with trabectedin results in 30% progression-free survival at 6 months. More than 50% of these ...

5. esmoopen.com esmoopen.com/article/S2059-7029(21)00170-8/fulltext

A single-arm multicentre phase II trial of doxorubicin in ... In uterine LMSs, first-line trabectedin is associated with ∼10% of patients achieving an objective response, a median PFS of 5.8 months, and a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11403398/

Doxorubicin and trabectedin for recurrent leiomyosarcoma The promising results of that trial, including a partial response rate of 60 % and disease control rate of 87 %, steered the development of the ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/14796694.2025.2463881

Full article: Doxorubicin and trabectedin in leiomyosarcoma Although some combination therapies demonstrated modest progression-free survival (PFS) outcomes, none had demonstrated significant overall survival (OS) ...