Ovarian Cancer Clinical Trial
Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies
Summary
This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.
Eligibility Criteria
Inclusion Criteria:
18 years old or greater
Malignancy scheduled to receive etoposide and carboplatin therapy
Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1
Adequate bone marrow, liver, renal function and coagulation status
Informed consent
Agree to use birth control through 28 days of last treatment dose
Pregnancy test for women of child-bearing potential
No available standard therapy
Exclusion Criteria:
Allergy to the the study treatment drugs
Unstable current medical condition
Presence or history of injury to the urinary tract
Active infection
Major surgery within 4 weeks prior to treatment
Minor surgery within 2 weeks prior to treatment
Current acute steroid therapy or taper
Currently pregnant or nursing
Substance abuse or condition that may interfere with participation
Received other investigational drugs within 30 days
Within 4 weeks of their last chemotherapy
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There are 4 Locations for this study
Indianapolis Indiana, 46202, United States
Lafayette Indiana, 47905, United States
Muncie Indiana, 47303, United States
St. Louis Missouri, 63110, United States
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