Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Leiomyosarcoma, Uterine Neoplasm

Intervention / Treatment
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* Drug: gemcitabine, docetaxel, doxorubicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: gemcitabine/docetaxel then doxorubicin<br>Gemcitabine 900 mg/m2 IV over 90 minutes days 1 and 8 Docetaxel 75 mg/m2 IV day 8 (pre-medication dexamethasone 4-8 mg p.o. bid for 3 days, starting 12-24 hours prior to docetaxel). Doxorubicin 60 mg/m2 IVP every 21 days for 4 cycles (recommend use of central venous catheter access). | Drug: gemcitabine, docetaxel, doxorubicin<br>* Cycles = 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS |  | Every 3 months up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Correlation Between Age and Tumor Response to Treatment (PFS) |  | 2 years | 
| Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS) |  | 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 | 2 years | 
| Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS) | Mitotic rate is measured in mitoses per 10 high-power fields | 2 years | 
| Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS) |  | 2 years | 
| Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS) |  | 2 years | 
| 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 | 
| Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early stage, high grade, uterine leiomyosarcoma, adjuvant treatment