Warfarin and Vatalanib in Treating Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

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 treatment for advanced solid tumors. PURPOSE: This phase I trial is studying how well giving warfarin together with vatalanib works in treating patients with advanced solid tumors.

Key facts

Study ID

NCT00091299

Run by

Jonsson Comprehensive Cancer Center

People needed

24

Starts

2004-05-01

Expected to finish

2012-08-01

Last updated by the study team

2020-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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])

Where it is running

• Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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