Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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.
- 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
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
FEMALE
Accepts Healthy Volunteers
No