Clinical Trial: Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Sarcoma Alliance for Research through Collaboration

Current Primary Outcome: 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 ]

Original Primary Outcome: determine two-year progression-free survival among women treated with this adjuvant regimen for high risk uterine LMS

Current Secondary Outcome:

  • Tolerability/Toxicity of This Regimen [ Time Frame: Every 28 days during dosing and then every 3 months thereafter until patient comes off study ]
    Unacceptable toxicity is defined as grade 3 or 4 non-hematologic toxicity events that are considered to be treatment-related, excluding alopecia and fatigue.
  • 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) [ Time Frame: 2 years ]
    AJCC Stage I: No serosal involvement AJCC Stage II: No serosal involement AJCC Stage III: Serosal only
  • Correlation Between Mitotic Rate and Tumor Response to Treatment (PFS) [ Time Frame: 2 years ]
    Mitotic rate is measured in mitoses per 10 high-power fields
  • 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) [ Time Frame: 2 years ]
    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)
  • Correlation Between Estrogen Receptor (ER) or Progesterone Receptor (PR) Positive and Tumor Response to Treatment (PFS) [ Time Frame: 2 years ]


Original Secondary Outcome:

  • dtermine tolerability/toxicity of this regimen
  • Improve understanding of behavior of uterine LMS through data collection


Information By: Sarcoma Alliance for Research through Collaboration

Dates:
Date Received: January 24, 2006
Date Started: January 2006
Date Completion:
Last Updated: November 23, 2014
Last Verified: November 2014