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A Phase II Trial of Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Thank you

Trial Information

A Phase II Trial of Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

- 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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Response rate (defined as CR+ PR) for patients treated with sunitinib

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Susana M. Campos, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Sutent
  • sunitinib
  • Carcinoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Beth-Israel Deaconess Medical Center Boston, Massachusetts