Phase 2
Completed N=47
Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma
Leiomyosarcoma · Uterine Neoplasm
Source: ClinicalTrials.gov NCT00282087 ↗
Enrolled (actual)
47
Serious AEs
19.2%
Results posted
Dec 2014
Primary outcomePrimary: Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS — 78 percentage of participants — p=0.15
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Two-year Progression-free Survival Among Women Treated With This Adjuvant Regimen for High Risk Uterine LMS |
78 | 0.15 |
| SECONDARY Tolerability/Toxicity of This Regimen |
6 | — |
| SECONDARY Correlation Between Age and Tumor Response to Treatment (PFS) |
53 | — |
| SECONDARY Correlation Between Menopausal Status at Diagnosis and Tumor Response to Treatment (PFS) |
43; 4 | — |
| SECONDARY Correlation Between Uterine Serosal Involvement and Tumor Response to Treatment (PFS) |
0; 6; 41 | — |
| SECONDARY Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS) |
18 | — |
| SECONDARY Correlation Between Estrogen Receptor (ER) Status and Tumor Response to Treatment (PFS) |
24; 14 | — |
| SECONDARY Correlation Between Progesterone Receptor (PR) Status and Tumor Response to Treatment (PFS) |
19; 19 | — |
| SECONDARY Correlation Between 1988 FIGO Stage and Tumor Response to Treatment (PFS) |
38; 7; 2 | — |
| SECONDARY Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS) |
33; 14 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00282087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.