Status:
COMPLETED
Warfarin and Vatalanib in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vatalanib may stop the growth of tumor cells by stopping blood flow to the tumor. Warfarin may be effective in preventing the formation of blood clots in patients who are undergoing treatme...
Detailed Description
OBJECTIVES: Primary * Determine the acute and chronic changes in INR in patients with advanced solid tumors treated with low-dose warfarin and vatalanib. Secondary * Determine the steady-state pha...
Eligibility Criteria
Inclusion
- Histologically confirmed advanced solid tumor
- Progressed despite standard therapy OR no known standard therapy exists
- \-- Currently receiving OR a candidate for prophylactic low-dose warfarin (1 mg/day)
- INR ≤ 1.4
- Must be an extensive metabolizer of CYP2C9 (at least 1 wild type allelle: \*1)
- 18 and over
- Hemoglobin ≥ 9 g/dL
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- Albumin ≥ 3.0 g/dL
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- Creatinine ≤ 1.5 ULN OR
- Creatinine clearance \> 50 mL/min
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- More than 14 days since prior anticancer chemotherapy
- More than 14 days since prior anticancer hormonal therapy
- More than 14 days since prior anticancer radiotherapy
- More than 14 days since other prior anticancer therapy
- More than 30 days since prior investigational drugs
- No ethanol for 2 days prior to and for the first 17 days of study treatment
Exclusion
- No poor metabolizers of CYP2C9 (2 alleles of either \*2 or \*3)
- brain metastases
- history of or active coagulation disorders
- significant risk for bleeding
- uncontrolled high blood pressure (BP), defined as diastolic BP \> 90 mm Hg or systolic BP \> 140 mm Hg
- history of cerebral or aortic aneurysm
- pregnant or nursing
- recent history or evidence of drug or alcohol abuse
- active peptic ulcer disease or gastrointestinal bleeding
- contraindication or allergy to warfarin or related compounds
- risk for adverse events related to prolonged PT/PTT due to warfarin administration
- other medical condition that would preclude study participation
- concurrent chemotherapy
- concurrent hormonal therapy
- concurrent radiotherapy
- other concurrent CYP2C9 substrates or inhibitors
- concurrent CYP3A4 inducers or inhibitors
- concurrent food or dietary supplement known to alter the metabolism of CYP3A4 (e.g., grapefruit or Hypericum perforatum \[St. John's wort\])
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00091299
Start Date
May 1 2004
End Date
August 1 2012
Last Update
August 5 2020
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-7187