Status:
COMPLETED
Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal Cancers
Lead Sponsor:
CritiTech, Inc.
Collaborating Sponsors:
University of Kansas Medical Center
Beckloff Associates, Inc.
Conditions:
Peritoneal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in patients with refractory...
Detailed Description
This is an open-label, Phase 1, dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticle paclitaxel (Nanot...
Eligibility Criteria
Inclusion
- Patients must be at least 18 years of age.
- Patients must have histologic or cytologic diagnosis of carcinoma predominantly confined to the peritoneal cavity.
- Patients must have failed all potentially curative therapy and have no other systemic treatment options available for extra-peritoneal disease. Patients with ovarian cancer that are platinum sensitive must have failed primary and at least one salvage regimen. Patients may undergo surgical debulking prior to entry into the trial.
- At least 28 days must have elapsed since completion of any other previous chemotherapy treatment received prior to registration in this study.
- Patients may have received prior abdominal surgery greater than 2 weeks prior to registration. Patients must have recovered from all effects of the surgical procedure.
- Patients must have a Zubrod Performance Status of 0 - 2.
- Patients must have a pretreatment granulocyte count greater than or equal to 1,500/microliter and platelet count greater than or equal to 100,000/microliter obtained within 14 days prior to registration.
- Patients must have adequate renal function as documented by a serum creatinine less than or equal to 1.5 times the institutional upper limit of normal obtained within 14 days prior to registration.
- Patients must have adequate hepatic function as documented by a bilirubin of less than or equal to 2 times the institutional upper limit of normal and an SGOT less than 5 times the institutional upper limit of normal obtained within 14 days prior to registration. Patients with hepatobiliary stents are eligible for this trial if the bilirubin meets the above parameter.
- There should be no plans for the patient to receive concomitant radiation therapy, hormonal therapy, or other chemotherapy for their tumor while on this protocol.
Exclusion
- Patients with active inflammatory bowel disease or chronic diarrhea
- Patients with uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within previous 6 months or serious uncontrolled cardiac arrhythmia
- Patients with active infection requiring systemic therapy
- Pregnant or nursing women
- Patients with Grade 2 or greater sensory neuropathy (by NCI Common Toxicity Criteria) at the time of study registration
- Patients taking concomitant medications demonstrated to inhibit or induce CYP3A4 or CYP2C8
- Patients with pre-existing conditions that prohibit the use of intravenous dexamethasone at the recommended dose
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00666991
Start Date
July 1 2008
End Date
May 1 2013
Last Update
February 27 2014
Active Locations (3)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
Cancer Center of Kansas
Wichita, Kansas, United States, 67208
3
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States, 73104