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

Primary Purpose

Peritoneal Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
nanoparticulate paclitaxel
Sponsored by
CritiTech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Neoplasms focused on measuring ovarian cancer, Mullerian tumors, peritoneal cavity carcinoma, gastrointestinal tract tumor, GI tract tumor, pancreatic cancer, colon cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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

Sites / Locations

  • University of Kansas Medical Center
  • Cancer Center of Kansas
  • Peggy and Charles Stephenson Oklahoma Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Nanotax, 50 mg/m2

Nanotax, 82.5 mg/m2

Nanotax, 125 mg/m2

Nanotax, 175 mg/m2

Nanotax, 225 mg/m2

Nanotax 275 mg/m2

Arm Description

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 50 mg/m2 once every 28 days until progression or unacceptable toxicity

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 82.5 mg/m2 once every 28 days until progression or unacceptable toxicity

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 125 mg/m2 once every 28 days until progression or unacceptable toxicity

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 175 mg/m2 once every 28 days until progression or unacceptable toxicity

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 225 mg/m2 once every 28 days until progression or unacceptable toxicity

Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 275 mg/m2 once every 28 days until progression or unacceptable toxicity

Outcomes

Primary Outcome Measures

Determine maximum tolerated dose and to assess qualitative and quantitative toxicities

Secondary Outcome Measures

Determine preliminary anti-tumor activity using RECIST criteria
Determine pharmacokinetics of intraperitoneal administration

Full Information

First Posted
April 23, 2008
Last Updated
February 26, 2014
Sponsor
CritiTech, Inc.
Collaborators
University of Kansas Medical Center, Beckloff Associates, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00666991
Brief Title
Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal Cancers
Official Title
A Phase 1 Study of Intraperitoneal Nanoparticle Paclitaxel in Patients With Peritoneal Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CritiTech, Inc.
Collaborators
University of Kansas Medical Center, Beckloff Associates, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Neoplasms
Keywords
ovarian cancer, Mullerian tumors, peritoneal cavity carcinoma, gastrointestinal tract tumor, GI tract tumor, pancreatic cancer, colon cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nanotax, 50 mg/m2
Arm Type
Experimental
Arm Description
Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 50 mg/m2 once every 28 days until progression or unacceptable toxicity
Arm Title
Nanotax, 82.5 mg/m2
Arm Type
Experimental
Arm Description
Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 82.5 mg/m2 once every 28 days until progression or unacceptable toxicity
Arm Title
Nanotax, 125 mg/m2
Arm Type
Experimental
Arm Description
Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 125 mg/m2 once every 28 days until progression or unacceptable toxicity
Arm Title
Nanotax, 175 mg/m2
Arm Type
Experimental
Arm Description
Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 175 mg/m2 once every 28 days until progression or unacceptable toxicity
Arm Title
Nanotax, 225 mg/m2
Arm Type
Experimental
Arm Description
Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 225 mg/m2 once every 28 days until progression or unacceptable toxicity
Arm Title
Nanotax 275 mg/m2
Arm Type
Experimental
Arm Description
Nanoparticulate paclitaxel (Nanotax) administered via intraperitoneal infusion at a dose of 275 mg/m2 once every 28 days until progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
nanoparticulate paclitaxel
Other Intervention Name(s)
Nanotax
Intervention Description
This is a Phase 1, dose-escalation study with 6 cohorts of 1 - 6 patients. Patients receive Nanotax via intraperitoneal infusion once every 28 days continuing on this treatment schedule until disease progression or unacceptable toxicity is experienced. Dosing cohorts are as follows: 50 mg/m2, 82.5 mg/m2, 125 mg/m2, 175 mg/m2, 225 mg/m2, and 275 mg/m2.
Primary Outcome Measure Information:
Title
Determine maximum tolerated dose and to assess qualitative and quantitative toxicities
Time Frame
Through last patient visit
Secondary Outcome Measure Information:
Title
Determine preliminary anti-tumor activity using RECIST criteria
Time Frame
Through last patient visit
Title
Determine pharmacokinetics of intraperitoneal administration
Time Frame
Up to 14 days following Cycles 1 and 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Johnson, M.D.
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julia Chapman, M.D.
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas K Schulz, M.D.
Organizational Affiliation
Cancer Center of Kansas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathleen Moore, MD
Organizational Affiliation
Peggy and Charles Stephenson Oklahoma Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Peggy and Charles Stephenson Oklahoma Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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