Heated chemotherapy after surgery for uterine leiomyosarcoma

Phase 2 Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Gemcitabine Followed by Systemic Adjuvant Chemotherapy With Dacarbazine for Locally Recurrent Uterine Leiomyosarcoma (LMS)

This study is testing whether a combination of surgery and heated chemotherapy can help people with recurrent uterine leiomyosarcoma avoid cancer coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Stanford University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Stanford, California)
• Trial ID: NCT04727242 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of cytoreductive surgery combined with heated chemotherapy using gemcitabine, followed by systemic chemotherapy with dacarbazine in patients with locally recurrent uterine leiomyosarcoma. The primary goal is to determine if this approach reduces the risk of cancer recurrence. Secondary objectives include assessing the safety of the treatment and measuring intraabdominal relapse-free survival at 6 and 12 months, as well as evaluating the quality of life of participants at various stages of treatment.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with a confirmed diagnosis of locally recurrent uterine leiomyosarcoma who are eligible for radical surgery.

Not a fit: Patients with advanced disease not amenable to surgery or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly lower the risk of cancer recurrence in patients with uterine leiomyosarcoma.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination of treatments is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed diagnosis of uterine leiomyosarcoma (LMS) with evidence of local recurrence.
2. Imaging provides evidence of locally recurrent uterine LMS.
3. Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician.
4. Age ≥ 18 years.
5. Life expectancy \> 3 months.
6. Women of childbearing potential (WOCBP) will have a negative pregnancy test ≤ 7 days prior to surgery (this test can be omitted if subject is post menopausal by either surgery or elevated FSH)
7. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
8. Hemoglobin (HGB) ≥ 9 g/dL.
9. White blood cell count (WBC) ≥ 3.0 K/ul.
10. Absolute neutrophil count (ANC) ≥ 1.5 K/ul.
11. Platelets (PLT) ≥ 100 K/ul.
12. Total bilirubin within normal institutional limits.
13. Serum glutamic oxaloacetic transaminase (SGOT/Serum glutamic pyruvic transaminase (SGPT) \< 2.5 x institutional upper limit of normal (ULN).
14. Creatinine \< 1.5 x ULN or creatinine clearance \> 60 mL/min according to Cockroft Gault formula.
15. Prothrombin Time (PT) such that international normalized ratio (INR) is \< 1.5 (or an in range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) \< 1.2 times control.
16. Serum albumin ≥ 2.5 g/dL.
17. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

Note that this study does not allow the use of a legally authorized representative

Exclusion Criteria:

1. Recurrence of LMS within less than 6 months after the last dose of gemcitabine.
2. Active extra abdominal disease including active malignant pleural effusion. Subjects who have been successfully treated with neoadjuvant chemotherapy and no longer have (malignant) pleural effusions may be included.
3. Prior gemcitabine given in non adjuvant setting.
4. Prior treatment with dacarbazine.
5. Active infection requiring antibiotics.
6. Unresolved toxic effects of prior therapy (except alopecia). Resolution is considered ≤ Grade 1 per NCI CTCAE, version 5.0.
7. Pregnant.
8. Breast feeding.
9. Presence of metastatic liver disease

Where this trial is running

Stanford, California

• Stanford University — Stanford, California, United States (Recruiting)

Study contacts

• Principal investigator: Kristen N Ganjoo, MD — Stanford University
• Study coordinator: Amanda Siy

Conditions LMS - Leiomyosarcoma; Uterine Leiomyosarcoma