Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Phase 2CompletedNCT00282087

Sarcoma Alliance for Research through Collaboration47 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leiomyosarcoma Uterine Neoplasm

Interventions

gemcitabine, docetaxel, doxorubicinDRUG

Cycles = 28 days

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Washington Cancer Institute/Washington Hospital Center (Medstar)

Washington D.C., District of Columbia, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Winship Cancer Institute at Emory University

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS

Time frame: Every 3 months up to two years

Secondary Outcomes

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.

Time frame: Every 28 days during dosing and then every 3 months thereafter until patient comes off study

Correlation Between Age and Tumor Response to Treatment (PFS)

Time frame: 2 years

Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS)

Time frame: 2 years

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

Time frame: 2 years

Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS)

Mitotic rate is measured in mitoses per 10 high-power fields

Time frame: 2 years

Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS)

Time frame: 2 years

Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS)

Time frame: 2 years

Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS)

Data from ClinicalTrials.gov

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