Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies the side effects and how well sunitinib malate works in treating patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer. Sunitinib malate may inhibit the ability of cancers to grow blood vessels, something they need to grow. It may also shrink tumors.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the efficacy (response rate) of sunitinib (sunitinib malate) given orally daily in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

II. To assess the toxicity of sunitinib in patients with advanced or metastatic previously treated epithelial ovarian, fallopian tube or primary peritoneal carcinoma.

III. To document cancer antigen 125 (CA125) response rate, early objective progression rate, and, if objective responses are observed, response duration.

OUTLINE:

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months thereafter. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00388037
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date January 2007
Completion date January 2012

See also
  Status Clinical Trial Phase
Completed NCT00390234 - Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma Phase 2
Terminated NCT00091195 - Depsipeptide (Romidepsin) in Treating Patients With Recurrent Ovarian Epithelial or Peritoneal Cavity Cancer Phase 2
Completed NCT00096395 - Sorafenib Tosylate and Gemcitabine Hydrochloride in Treating Patients With Recurrent Epithelial Ovarian Cancer Phase 2
Completed NCT00026091 - Fenretinide in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer Phase 2
Terminated NCT01962948 - Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Phase 1/Phase 2
Completed NCT01846520 - Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers N/A
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Completed NCT01764789 - Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer N/A
Completed NCT00093496 - Gemcitabine Hydrochloride and Tanespimycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer Phase 2
Completed NCT00132067 - Vorinostat in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cavity Cancer Phase 2
Completed NCT00275028 - AZD2171 in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Phase 2
Completed NCT00006942 - Bryostatin 1 and Cisplatin in Treating Patients With Advanced Recurrent or Residual Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Phase 2
Completed NCT00004032 - Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer Phase 1
Completed NCT00023712 - Bortezomib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer Phase 2
Terminated NCT01249443 - Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Phase 1
Completed NCT02046421 - Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Completed NCT00028535 - Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors Phase 1
Completed NCT01747798 - Auranofin in Treating Patients With Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Early Phase 1
Completed NCT01652794 - Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer Phase 1
Withdrawn NCT01558778 - Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant N/A