CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma

Primary Objective:

• To assess the efficacy of cytoreductive surgery with gemcitabine HIPEC followed by postoperative systemic chemotherapy with dacarbazine in subjects with locally recurrent uterine LMS.

Secondary Objectives:

• To assess the safety of cytoreductive surgery with gemcitabine HIPEC in subjects with locally recurrent uterine LMS.
• To assess the 6 month and 12 month intraabdominal relapse free survival in subjects with locally recurrent uterine LMS
• To determine quality of life prior to therapy (within 28 days prior to surgery with HIPEC), 4 to 6 weeks after surgery with HIPEC, and then at Cycle

Inclusion criteria

• 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 criteria

• 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