Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Leiomyosarcoma Clinical Trial

Official title:

Adjuvant Treatment of High Risk Uterine Leiomyosarcoma With Gemcitabine/Docetaxel Followed by Doxorubicin: A Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282087
• Other study ID #: SARC005
• Secondary ID: MSKCC05-128
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2006
• Last updated: November 23, 2014
• Start date: January 2006
• Est. completion date: January 2012

Study information

• Verified date: November 2014
• Source: Sarcoma Alliance for Research through Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.

Description:

Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years of age

• high risk uterine LMS, FIGO stage I or II

• pathology review of LMS high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf

• no longer than 12 weeks from surgical resection of cancer

• no evidence of residual disease

• ECOG 0 or 1

• ANC = 1,500, hemoglobin = 8.0, platelets =100,000

• creatinine = 1.5 x institutional upper limits of normal

• adequate liver function

• neuropathy (sensory and motor) = CTC grade 1

• negative pregnancy test

• signed consent

Exclusion Criteria:

• patients with other invasive malignancies

• prior therapy with gemcitabine or docetaxel or doxorubicin

• hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

• women who are breast feeding

• cardiac ejection fraction <50%

• prior pelvic irradiation

• treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyosarcoma
• Uterine Neoplasm
• Uterine Neoplasms

Intervention

Drug:
• gemcitabine, docetaxel, doxorubicin
Cycles = 28 days

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Winship Cancer Institute at Emory University	Atlanta	Georgia
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	St. Vincent Gynecologic Oncology	Indianapolis	Indiana
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Pennsylvania Oncology Hematology Associates	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Washington Cancer Institute/Washington Hospital Center (Medstar)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sarcoma Alliance for Research through Collaboration

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS		Every 3 months up to two years	Yes
Secondary	Tolerability/Toxicity of This Regimen	Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.	Every 28 days during dosing and then every 3 months thereafter until patient comes off study	Yes
Secondary	Correlation Between Age and Tumor Response to Treatment (PFS)		2 years	No
Secondary	Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)		2 years	No
Secondary	Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS)	AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only	2 years	No
Secondary	Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)	Mitotic rate is measured in mitoses per 10 high-power fields	2 years	No
Secondary	Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)		2 years	No
Secondary	Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)		2 years	No
Secondary	Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)	Stage I: confined to the uterine corpus Stage II: confined to corpus and cervix Stage IIIA: serosa involvement only (disease could involve the uterine serosa, but patients must have had no other evidence of local spread)	2 years	No
Secondary	Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS)		2 years	No

External Links

•   SARC Website