Status:
ACTIVE_NOT_RECRUITING
CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma
Lead Sponsor:
Stanford University
Conditions:
LMS - Leiomyosarcoma
Uterine Leiomyosarcoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out if giving a dose of heated chemotherapy in the abdomen immediately after surgery that is done to remove uterine leiomyosarcoma type of cancer will help lower t...
Detailed Description
Primary Objective: \- To assess the efficacy of cytoreductive surgery with gemcitabine HIPEC followed by postoperative systemic chemotherapy with dacarbazine in subjects with locally recurrent uterin...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of uterine leiomyosarcoma (LMS) with evidence of local recurrence.
- Imaging provides evidence of locally recurrent uterine LMS.
- Candidate for potentially radical, maximal effort cytoreductive surgery at the discretion and expertise of the treating physician.
- Age ≥ 18 years.
- Life expectancy \> 3 months.
- 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)
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Hemoglobin (HGB) ≥ 9 g/dL.
- White blood cell count (WBC) ≥ 3.0 K/ul.
- Absolute neutrophil count (ANC) ≥ 1.5 K/ul.
- Platelets (PLT) ≥ 100 K/ul.
- Total bilirubin within normal institutional limits.
- Serum glutamic oxaloacetic transaminase (SGOT/Serum glutamic pyruvic transaminase (SGPT) \< 2.5 x institutional upper limit of normal (ULN).
- Creatinine \< 1.5 x ULN or creatinine clearance \> 60 mL/min according to Cockroft Gault formula.
- 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.
- Serum albumin ≥ 2.5 g/dL.
- 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
- Recurrence of LMS within less than 6 months after the last dose of gemcitabine.
- 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.
- Prior gemcitabine given in non adjuvant setting.
- Prior treatment with dacarbazine.
- Active infection requiring antibiotics.
- Unresolved toxic effects of prior therapy (except alopecia). Resolution is considered ≤ Grade 1 per NCI CTCAE, version 5.0.
- Pregnant.
- Breast feeding.
- Presence of metastatic liver disease
Key Trial Info
Start Date :
January 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04727242
Start Date
January 28 2021
End Date
May 1 2026
Last Update
November 25 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305