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

Brief Title

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

Official Title

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

Brief Summary

      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.

Detailed Description

      This study used a two-stage design to evaluate efficacy of sunitinib based on overall
      response (OR) defined as complete response (CR) or partial response (PR). The null and
      alternative OR rate were 5% and 20%. If one or more patients enrolled in the stage one cohort
      (n=17 patients) achieved PR or better than accrual would proceed to stage two (n=18
      patients). There was 42% probability of stopping the trial at stage one if the true OR rate
      was 5%. With 35 patients, this design had 85% power to detect the 15% difference in OR rates
      assuming 2-sided type I error rate of 0.05.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Overall Response Rate

Secondary Outcome

 16-Week Progression-Free Survival

Condition

Ovarian Cancer

Intervention

Sunitinib

Study Arms / Comparison Groups

 Sunitinib

Description:  Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

September 2008

Completion Date

February 2013

Primary Completion Date

May 2012

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Susana M. Campos, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00768144

Organization ID

08-056

Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Beth Israel Deaconess Medical Center

Study Sponsor

Susana M. Campos, MD, Principal Investigator, Dana-Farber Cancer Institute

Verification Date

July 2018