Peritoneal Neoplasms Clinical Trial
Official title:
A Phase 1 Study of Intraperitoneal Nanoparticle Paclitaxel in Patients With Peritoneal Malignancies
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.
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 and up to 14 days following
infusion for Cycle 1 and Cycle 2 only. Evaluation of tumor response using RECIST criteria
will be conducted following each treatment cycle.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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