Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

• ClinicalTrials.gov Identifier: NCT00282087
• Recruitment Status: Completed
• First Posted: January 25, 2006
• Results First Posted: December 1, 2014
• Last Update Posted: December 1, 2014
• Sponsor: Sarcoma Alliance for Research through Collaboration
• Information provided by (Responsible Party): Sarcoma Alliance for Research through Collaboration

Tracking Information

• First Submitted Date: January 24, 2006
• First Posted Date: January 25, 2006
• Results First Submitted Date: July 19, 2013
• Results First Posted Date: December 1, 2014
• Last Update Posted Date: December 1, 2014
• Study Start Date: January 2006
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 23, 2014): 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 Measures (submitted: January 24, 2006): determine two-year progression-free survival among women treated with this adjuvant regimen for high risk uterine LMS

Current Secondary Outcome Measures (submitted: November 23, 2014)

• 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 Measures (submitted: January 24, 2006)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma
• 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 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Leiomyosarcoma
• Uterine Neoplasm

Intervention

Drug: gemcitabine, docetaxel, doxorubicin

Cycles = 28 days

Study Arms

gemcitabine/docetaxel then doxorubicin

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).

Intervention: Drug: gemcitabine, docetaxel, doxorubicin

• Publications *: Hensley ML, Wathen JK, Maki RG, Araujo DM, Sutton G, Priebat DA, George S, Soslow RA, Baker LH. Adjuvant therapy for high-grade, uterus-limited leiomyosarcoma: results of a phase 2 trial (SARC 005). Cancer. 2013 Apr 15;119(8):1555-61. doi: 10.1002/cncr.27942. Epub 2013 Jan 18.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2012): 47
• Original Enrollment (submitted: January 24, 2006): 45
• Actual Study Completion Date: January 2012
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00282087
• Other Study ID Numbers: SARC005; MSKCC05-128 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sarcoma Alliance for Research through Collaboration
• Original Responsible Party: Not Provided
• Current Study Sponsor: Sarcoma Alliance for Research through Collaboration
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Martee L. Hensley, MD; Memorial Sloan Kettering Cancer Center

• PRS Account: Sarcoma Alliance for Research through Collaboration
• Verification Date: November 2014