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Tailored-dose Sorafenib Plus Metronomic Cyclophosphamide in Advanced Neuroendocrine Tumors (NET): a Phase II Clinical Trial Based on Individual Pharmacodynamic Assessment


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Neuroendocrine Tumors

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Trial Information

Tailored-dose Sorafenib Plus Metronomic Cyclophosphamide in Advanced Neuroendocrine Tumors (NET): a Phase II Clinical Trial Based on Individual Pharmacodynamic Assessment


Inclusion Criteria:



- Histologically or cytologically confirmed neuroendocrine tumors

- Progressive and measurable metastatic disease

- Patients must not have disease that is currently amenable to surgery

- Life expectancy of greater than 3 months

- ECOG performance status ≤2

- Patients must have normal organ and marrow function

- Negative pregnancy test; agreement to use adequate birth control

Exclusion Criteria:

- Patients receiving chemotherapy or radiotherapy within last 4 weeks

- Patients that had received Sorafenib for advanced NET(neuroendocrine tumors) are
not allowed

- Any other investigational agents within 4 weeks of study

- Patients with known brain metastases

- History of allergic reactions to compounds of similar chemical/biologic composition
to sorafenib or cyclophosphamide

- Concurrent cancer from another primary site requiring treatment within the past 3
years

- Uncontrolled intercurrent illness

- Pregnant women and women who are breastfeeding

- HIV-positive patients receiving combination anti-retroviral therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the efficacy of combination sorafenib plus metronomic cyclophosphamide in advanced, progressive NET, as measured by the objective response rate (ORR), and to assess the feasibility of the individual dose adjustment of sorafenib.

Outcome Time Frame:

Every 8 weeks

Safety Issue:

No

Principal Investigator

Lillian Siu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

Canada: Ethics Review Committee

Study ID:

SOR-NET-001

NCT ID:

NCT00605566

Start Date:

January 2008

Completion Date:

May 2013

Related Keywords:

  • Neuroendocrine Tumors
  • Neuroendocrine
  • sorafenib
  • cyclophosphamide
  • pharmacodynamic
  • Neuroendocrine Tumors

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