Dr. Martee Hensley. Associate Attending, Gynecologic Medical Oncology Service, Memorial Sloan-Kettering Cancer Center, is the Principal Investigator for this clinical trial for women with uterine leiomyosarcoma which is open to accrual at sites across the United States. 

 

Trial Background

Leiomyosarcoma is a type of cancer that can affect the uterus.  Women with early stage leiomyosarcoma have approximately 50- 70% chance of relapse/recurrence of their disease.  The purpose of this national study is to evaluate if a combination of chemotherapy drugs given after surgery will reduce the chance that the cancer will come back.  The reason that physicians would consider the combination of gemcitabine and docetaxel for women with high risk leiomyosarcoma following surgery is based on information learned from a clinical trial that studied this combination in women who had metastatic disease.  Fifty percent (50%) of women who had metastatic leiomyosarcoma had objective response rates to this combination of chemotherapy drugs.  This study will also evaluate if this therapy will be safe and well tolerated by observing the side effects associated with the treatment. 

 

Trial

In this trial, three drugs will be given:  Gemcitabine, docetaxel and doxorubicin.  These drugs are all FDA approved drugs for the treatment of various types of cancer.  As part of this study, women will receive gemcitabine/docetaxel first followed by doxorubicin.  The combination of gemcitabine/docetaxel has already been shown to be safe and to decrease the size of leiomyosarcoma tumors of the uterus that have come back or have continued to grow despite treatment with other chemotherapy drugs.  Doxorubicin has also been shown to be safe when given to women with leiomyosarcoma of the uterus and to decrease the size of these tumors.

 

In addition, the investigators will look at certain features of each woman’s cancer to see if there are any particular factors that may predict which woman may have a higher risk of cancer recurrence.  To perform these tests, the investigators may need to request additional slides that contain a small piece of the tumor that had been previously removed. Patients will not need to have any additional surgery or biopsy done for these tests to be completed.  The results will not affect the treatment on this study but may help women in the future who develop high risk leiomyosarcoma.

 

Participation in the trial

To be eligible to participate in this trial a woman must:

1.  Have confirmed diagnosis of high-risk uterine leiomyosarcoma that has not spread beyond the uterus and cervix.

2.  Have had surgery (hysterectomy), within 12 weeks of entering the study

3.  Appear to be free of cancer after surgery

4.  Must be age 18 or older

5.  Be active, able to perform light physical activity (such as light housework or office work)

 

Women would NOT be able to participate in the study if they have:

1. Received radiation to the pelvis

2. Received treatment with gemcitabine, docetaxel, or doxorubicin

3. Have evidence that the cancer has already come back or spread

 

*this represents only a partial list of requirements to be included or excluded from the study.  A complete list is available from SARC or Dr. Hensley.

 

For more information contact SARC at 734.930.7600 or Dr. Hensley at 212.639.6902.

 

This trial is registered at clinicaltrials.gov

 

The full title is: A Phase II Study Assessing Adjuvant Treatment of High-Risk Uterine Leiomyosarcoma with gemcitabine/docetaxel, followed by doxorubicin (SARC005)

 

Glossary:

*gemcitabine (brand name Gemzar)

*docetaxel (brand name Taxotere)

*doxorubicin (brand name Adriamycin)