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
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Response rate (defined as CR+ PR) for patients treated with sunitinib [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 35
Study Start Date: September 2008
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sunitinib
    Taken orally once a day in the evening
    Other Name: Sutent
Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768144

Locations
United States, Massachusetts
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Susana M. Campos, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Susana Campos, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00768144     History of Changes
Other Study ID Numbers: 08-056
Study First Received: September 29, 2008
Last Updated: December 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Sutent
sunitinib

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014