Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Dana-Farber Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00768144
First received: September 29, 2008
Last updated: December 17, 2010
Last verified: December 2010

September 29, 2008
December 17, 2010
September 2008
September 2011   (final data collection date for primary outcome measure)
Response rate (defined as CR+ PR) for patients treated with sunitinib [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00768144 on ClinicalTrials.gov Archive Site
  • Clinical benefit defined as CR+ PR+ SD greater than 6 months [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety of this agent in this patient population [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
A Phase II Trial of Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

The purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor.

  • Each treatment cycle lasts 28 days during which participants will take sunitinib orally every evening before going to sleep.
  • During all treatment cycles participants will have a physical exam and will be asked questions about their general health and specific questions about any problems they may be having.
  • A CT or MRI scan will be performed every two cycles (8 weeks) of therapy for the first 6 cycles, then every 3 cycles (12 weeks) after that.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
Drug: Sunitinib
Taken orally once a day in the evening
Other Name: Sutent
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
Not Provided
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed epithelial ovarian, fallopian tube or peritoneal cancer
  • Recurrent or refractory disease
  • Measurable disease, defined by RECIST
  • 0 to 3 prior cytotoxic chemotherapy or biologic regimens for metastatic disease
  • Adverse events related to prior tumor-specific therapy must have resolved to less than or equal to grade 1 prior to study entry
  • Ability to swallow oral medications
  • 18 years of age or older
  • ECOG Performance status must be 0-2
  • Normal organ and marrow function as outlined in the protocol

Exclusion Criteria:

  • Receiving systemic therapy less than 14 days prior to starting sunitinib
  • Receiving any other investigational agent
  • Received prior sunitinib
  • Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on screening CT or MRI scans
  • Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
  • Evidence of a bleeding diathesis. Major surgery or NCI CTCA 3.0 grade 3 or worse hemorrhage within 4 weeks of starting study treatment
  • Ongoing cardiac dysrhythmias of NCI CTCAE version 3.0 grade > 2
  • Pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication
  • Prolonged QTc interval on baseline EKG
  • Uncontrolled hypertension
  • Patients who are taking cytochrome P450 enzyme-inducing antiepileptic drugs, rifampin, theophylline, ketoconazole, or St. John's wort.
  • Psychiatric illness or social situations that wold limit compliance with study requirements
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
  • Pregnant women
  • Clinical or radiographical evidence of a small bowel obstruction
  • Poor oral intake
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00768144
08-056
Yes
Susana Campos, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
Principal Investigator: Susana M. Campos, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP