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Cytoreductive Surgery with Gemcitabine Followed by Dacarbazine for the Treatment of Locally Recurrent Uterine Leiomyosarcoma

Trial Status: Active

This phase II trial studies the effects of giving a dose of heated chemotherapy (gemcitabine) in the abdomen immediately after cytoreductive surgery in patients with uterine leiomyosarcoma that has come back (locally recurrent). Cytoreductive surgery is a surgical procedure that aims to remove all visible tumors from the abdominal cavity. Heated chemotherapy is a treatment that uses heated chemotherapy inside the abdomen at the time of surgery to try to eliminate any remaining cancer cells and decrease chances of disease recurrence. Chemotherapy drugs, such as gemcitabine and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving a dose of heated chemotherapy in the abdomen immediately after cytoreductive surgery may lower the risk of the cancer coming back in the future.

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 follicle-stimulating hormone [FSH])
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Hemoglobin (HGB) >= 9 g/dL
  • White blood cell count (WBC) >= 3,000/uL
  • Absolute neutrophil count (ANC) >= 1,500/uL
  • Platelets (PLT) >= 100,000/uL
  • Total bilirubin within normal institutional limits
  • Serum glutamic oxaloacetic transaminase/serum glutamic pyruvic transaminase (SGOT/SGPT) < 2.5 x institutional upper limit of normal (ULN)
  • Creatinine < 1.5 x ULN or creatinine clearance > 60 mL/min according to Cockcroft-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 Institutional Review Board (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 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
  • Pregnant
  • Breast-feeding
  • Presence of metastatic liver disease

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Contact: Kristen Nooshin Ganjoo
Phone: 650-725-6413

PRIMARY OBJECTIVE:

I. To assess the efficacy of cytoreductive surgery with gemcitabine hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative systemic chemotherapy with dacarbazine in subjects with locally recurrent uterine leiomyosarcoma (LMS).

SECONDARY OBJECTIVES:

I. To assess the safety of cytoreductive surgery with gemcitabine HIPEC in subjects with locally recurrent uterine LMS.

II. To assess the 6 month and 12 month intraabdominal relapse free survival in subjects with locally recurrent uterine LMS.

III. To determine quality of life prior to therapy (within 28 days prior to surgery with gemcitabine hyperthermic intraperitoneal chemotherapy [HIPEC]) and 4 to 6 weeks after surgery with HIPEC.

EXPLORATORY OBJECTIVES:

I. To collect biospecimens and perform correlative studies to examine circulating tumor deoxyribonucleic acid (DNA) levels before surgery and at every odd cycle of systemic chemotherapy (cycles 1, 3, 5).

II. To collect biospecimens and perform NextGen sequencing of tumors to look at mutations.

OUTLINE:

Patients undergo cytoreductive surgery and receive HIPEC with gemcitabine intraperitoneally (IP) over 60 minutes on day 0. Beginning 30 days after surgery, patients receive dacarbazine intravenously (IV) every 3 weeks (Q3W) for up to 6 doses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for years 1 and 2, every 4 months for year 3, and then every 6 months for years 4 and 5.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Stanford Cancer Institute Palo Alto

Principal Investigator
Kristen Nooshin Ganjoo

  • Primary ID SARCOMA0045
  • Secondary IDs NCI-2021-03258
  • Clinicaltrials.gov ID NCT04727242