Clinical Trial: Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal Cancers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Study of Intraperitoneal Nanoparticle Paclitaxel in Patients With Peritoneal Malignancies

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 malignancies principally confined to the peritoneal cavity.

Detailed Summary:

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 (Nanotax) in patients with refractory malignancies principally confined to the peritoneal cavity.

Nanotax will be administered via intraperitoneal infusion once every 28 days (equals one treatment cycle), continuing on this treatment schedule until disease progression or unacceptable toxicity is experienced.

This study will treat one patient per predefined dose level until one patient experiences a dose limiting toxicity (DLT) or until one patient has a Grade 2 or higher non-hematological toxicity or a Grade 3 or higher hematological toxicity during the first cycle of treatment. At this time, two additional patients will be treated at this dose level. If these 2 additional patients do not experience a DLT, then the next cohort of three patients will be treated at the next highest dose level. If 2/3 or 3/3 patients experience a DLT then the next cohort of three patients is enrolled at the next lower dose level. If 1/3 of the patients experience a DLT, then the next cohort of three patients is enrolled at the same dose level. If 0/3 patients experience a DLT, then the next cohort of three patients is enrolled at the next highest dose level. If 2 (or more)/6 patients at a given level experience a DLT, then the maximum tolerated dose has been exceeded and another cohort of three patients is treated at the next lower dose level.

The protocol will not treat above the highest dose level of 275 mg/m2.

Adverse event data will be collected throughout the study. Peritoneal fluid and blood samples will be collected prior to Nanotax administration
Sponsor: CritiTech, Inc.

Current Primary Outcome: Determine maximum tolerated dose and to assess qualitative and quantitative toxicities [ Time Frame: Through last patient visit ]

Original Primary Outcome: Evidence of dose limiting toxicity [ Time Frame: Within the 28 days following initial dosing ]

Current Secondary Outcome:

  • Determine preliminary anti-tumor activity using RECIST criteria [ Time Frame: Through last patient visit ]
  • Determine pharmacokinetics of intraperitoneal administration [ Time Frame: Up to 14 days following Cycles 1 and 2 ]


Original Secondary Outcome:

  • Determine preliminary anti-tumor activity using RECIST criteria [ Time Frame: 9 weeks following initial dosing ]
  • Determine pharmacokinetics of intraperitoneal administration [ Time Frame: Up to 14 days following Cycles 1 and 2 ]


Information By: CritiTech, Inc.

Dates:
Date Received: April 23, 2008
Date Started: July 2008
Date Completion:
Last Updated: February 26, 2014
Last Verified: February 2014