Warfarin and Vatalanib in Treating Patients With Advanced Solid Tumors

NCT00091299 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000386239UCLA-0403067-01NOVARTIS-CPTK7870113
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• To evaluate acute and chronic changes in INR when Warfarin is co-administered with PTK787/ZK 222584

  2 weeks

Secondary Outcomes (2)

• To evaluate the steady state pharmacokinetics of (R) and (S) Warfarin when co-administered with PTK787/ZK 222584

  2 weeks

• Safety of low dose warfarin when co-administered with PTK787/ZK 222584

  2 weeks

Study Arms (1)

warfarin

EXPERIMENTAL

Drug: warfarin

Interventions

warfarin DRUG

warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-7187, United States

Location

MeSH Terms

Interventions

Warfarin

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joel R. Hecht, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2004
• First Posted: September 9, 2004
• Study Start: May 1, 2004
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 5, 2020

Record last verified: 2012-08

Locations

US (1)