Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus

NCT00378911 | Completed Phase 2

• 4 other identifiers: NCI-2012-02702CDR0000495190GOG-0231CU10CA027469
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well sunitinib works in treating patients with recurrent or persistent leiomyosarcoma of the uterus. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Conditions

Recurrent Uterine Sarcoma; Uterine Leiomyosarcoma

Outcome Measures

Primary Outcomes (3)

• Progression-free survival

  From study entry until disease progression, death or date of last contact., assessed up to 6 months

• Objective tumor response according to GOG RECIST criteria

  Up to 5 years

• Frequency and severity of adverse events as assessed by CTCAE v 3.0

  The frequency and severity of all toxicities will be tabulated.

  Up to 5 years

Secondary Outcomes (2)

• Duration of progression-free survival

  Up to 5 years

• Duration of overall survival

  From entry into the study to death or the date of last contact, assessed up to 5 years

Study Arms (1)

Treatment (sunitinib malate)

EXPERIMENTAL

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

Given orally

Also known as: SU11248, sunitinib, Sutent

Treatment (sunitinib malate)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed leiomyosarcoma of the uterus
• Recurrent or persistent disease
• Refractory to curative therapy or established treatments
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Ascites and pleural effusions are not considered measurable disease
• Must have ≥ 1 target lesion to assess response
• Tumors in a previously irradiated field are considered non-target lesions unless there is documented progression or biopsy-confirmed persistence ≥ 90 days after completion of radiotherapy
• Received at least 1 but no more than 2 prior cytotoxic regimens
• Initial treatment may have included high-dose chemotherapy, consolidation, or extended therapy administered after surgery or nonsurgical assessment
• Cytotoxic regimens may have included any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
• Not a candidate for a higher priority GOG protocol
• No known brain metastases
• GOG performance status 0-2 (for patients who have received 1 prior regimen) OR GOG 0-1 (for patients who have received 2 prior regimens)
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Martee Hensley

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2006
• First Posted: September 21, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: January 1, 2010
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

US (1)