Trials / Completed
CompletedNCT00478426
Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer
A Phase 2 Study of Sunitinib Malate in Recurrent or Metastatic Endometrial Carcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial studies how well sunitinib malate works in treating patients with endometrial cancer that has come back after a period of improvement (recurrent) or has spread to other places in the body (metastatic). 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.
Detailed description
PRIMARY OBJECTIVES: I. To assess the objective response rate of recurrent or metastatic endometrial cancer to sunitinib (sunitinib malate). II. To assess the frequency of prolonged stable disease (as defined by percentage \[%\] of patients alive and free from progressive disease at 6 months) in patients with recurrent or metastatic endometrial cancer treated with sunitinib. SECONDARY OBJECTIVES: I. To assess time-to- progression, median overall survival, and rate of one-year survival in patients with recurrent or metastatic endometrial cancer treated with sunitinib. II. To assess the toxicity associated with sunitinib in patients with recurrent or metastatic endometrial cancer. OUTLINE: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After the completion of study treatment, patients are followed up at 4 weeks and then every 3 months until relapse.
Conditions
- Endometrial Adenocarcinoma
- Endometrial Endometrioid Adenocarcinoma
- Endometrial Serous Adenocarcinoma
- Recurrent Uterine Corpus Carcinoma
- Stage IVA Uterine Corpus Cancer AJCC v7
- Stage IVB Uterine Corpus Cancer AJCC v7
- Uterine Carcinosarcoma
- Uterine Corpus Carcinosarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sunitinib Malate | Given PO |
Timeline
- Start date
- 2007-04-30
- Primary completion
- 2019-02-12
- Completion
- 2019-02-12
- First posted
- 2007-05-24
- Last updated
- 2020-02-17
- Results posted
- 2020-02-17
Locations
29 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00478426. Inclusion in this directory is not an endorsement.