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

Primary Purpose

LMS - Leiomyosarcoma, Uterine Leiomyosarcoma

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Gemcitabine

Dacarbazine

Cytoreductive Surgery

Functional Assessment of Cancer Therapy (FACT) G questionnaire

Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan

Gadolinium

About this trial

This is an interventional treatment trial for LMS - Leiomyosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine

Arm Description

Cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine followed by postoperative systemic chemotherapy with dacarbazine. Conceptually, HIPEC will be administered as a 60 minute heated intraperitoneal infusion (ie, intraperitoneal "wash" or "lavage"). HIPEC: Gemcitabine will be instilled at a dose of 1000 mg/m2 for 60 minutes at temperatures of 42° to 43°C. Systemic adjuvant chemotherapy starting 30 days ± 14 days post surgery. Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles

Outcomes

Primary Outcome Measures

Progression free survival (PFS)

Progression free survival as measured from the time of surgery until death or disease progression.

Secondary Outcome Measures

Rate of Grade 4 infections

Rate of Grade 4 infections within 30 days post surgery with gemcitabine HIPEC will be assessed using CTCAE version 5.0.

Intraabdominal relapse free survival

Relapse free survival as measured from time of surgery until intraabdominal recurrence

Intraabdominal relapse free survival

Relapse free survival as measured from time of surgery until intraabdominal recurrence

Overall Functional Assessment of Cancer Therapy: General (FACT G) score

Difference in overall FACT G score from baseline to 4 to 6 weeks post-surgery with gemcitabine HIPEC. FACT G is a quality of life questionnaire composed of 27 items divided into four main quality of life categories: Physical Well Being (PWB); Social/Family Well Being (SWB); Emotional Well Being (EWB); and Functional Well Being (FWB). Total FACT G score is obtained by summing the scores from the four main QoL categories (PWB; SWB; EWB; FWB). The range of the scale is 0-108. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate better Quality of life (Qol).

Full Information

NCT ID

NCT04727242

First Posted

January 22, 2021

Last Updated

August 10, 2023

Sponsor

Kristen Ganjoo

1. Study Identification

Unique Protocol Identification Number

NCT04727242

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 28, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kristen Ganjoo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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 the risk of the cancer coming back in the future.

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

LMS - Leiomyosarcoma, Uterine Leiomyosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cytoreductive Surgery+HIPEC gemcitabine+dacarbazine

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar, Infugem, difluorodeoxycytidine hydrochloride

Intervention Description

Hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine. Gemcitabine will be instilled at a dose of 1000 mg/m2 for 60 minutes at temperatures of 42° to 43°C.

Intervention Type

Drug

Intervention Name(s)

Dacarbazine

Other Intervention Name(s)

Dimethyl (triazeno) imidazolecarboxamide, Dacarbazine - DTIC, Biocarbazine

Intervention Description

Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles given IV

Intervention Type

Procedure

Intervention Name(s)

Cytoreductive Surgery

Intervention Description

Surgery for cancer removal

Intervention Type

Behavioral

Intervention Name(s)

Functional Assessment of Cancer Therapy (FACT) G questionnaire

Intervention Description

Preoperative and Postoperative FACT G questionnaire to assess QoL

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan

Intervention Description

Radiologic imaging after Cycle 3 and 6 and at each follow up visit

Intervention Type

Drug

Intervention Name(s)

Gadolinium

Intervention Description

Contrast Agent

Primary Outcome Measure Information:

Title

Progression free survival (PFS)

Description

Progression free survival as measured from the time of surgery until death or disease progression.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Rate of Grade 4 infections

Description

Rate of Grade 4 infections within 30 days post surgery with gemcitabine HIPEC will be assessed using CTCAE version 5.0.

Time Frame

30 days post surgery with gemcitabine HIPEC

Title

Intraabdominal relapse free survival

Description

Relapse free survival as measured from time of surgery until intraabdominal recurrence

Time Frame

6 months

Title

Intraabdominal relapse free survival

Description

Relapse free survival as measured from time of surgery until intraabdominal recurrence

Time Frame

12 months

Title

Overall Functional Assessment of Cancer Therapy: General (FACT G) score

Description

Time Frame

Baseline, 4 to 6 weeks post-surgery with HIPEC

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ghazal Jawed

Phone

650-724-1388

gjawed@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristen N Ganjoo, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ghazal Jawed

Phone

650-724-1388

gjawed@stanford.edu

First Name & Middle Initial & Last Name & Degree

Kristen N Ganjoo, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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