Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal Cancers - Full Text View

Sponsors and Collaborators:	CritiTech, Inc. University of Kansas Medical Center Research Institute, Inc. Beckloff Associates, Inc.
Information provided by:	CritiTech, Inc.
ClinicalTrials.gov Identifier:	NCT00666991

Purpose

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.

Condition	Intervention	Phase
Peritoneal Neoplasms	Drug: nanoparticulate paclitaxel	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Study of Intraperitoneal Nanoparticle Paclitaxel in Patients With Peritoneal Malignancies

Further study details as provided by CritiTech, Inc.:

Primary Outcome Measures:

Determine maximum tolerated dose and to assess qualitative and quantitative toxicities [ Time Frame: Through last patient visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine preliminary anti-tumor activity using RECIST criteria [ Time Frame: Through last patient visit ] [ Designated as safety issue: No ]
Determine pharmacokinetics of intraperitoneal administration [ Time Frame: Up to 14 days following Cycles 1 and 2 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: nanoparticulate paclitaxel sterile suspension of nanoparticulate paclitaxel administered intraperitoneally on Day 1 of each 28 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.

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 300 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666991

Locations

United States, Kansas
University of Kansas Medical Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Marilyn Labinski, R.N. 913-588-4254 mlabinski@kumc.edu
Contact: Holly J. Smith, M.A. 913-588-4709 hsmith@kumc.edu
Principal Investigator: Stephen K Williamson, M.D.
Principal Investigator: Julia Chapman, M.D.

Sponsors and Collaborators

CritiTech, Inc.

University of Kansas Medical Center Research Institute, Inc.

Beckloff Associates, Inc.

Investigators

Principal Investigator:	Stephen K Williamson, M.D.	University of Kansas
Principal Investigator:	Julia Chapman, M.D.	University of Kansas

More Information

No publications provided

Responsible Party:	CritiTech, Inc. ( Sam D. Campbell/President and CEO )
Study ID Numbers:	HSC#11140
Study First Received:	April 23, 2008
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00666991 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by CritiTech, Inc.:

ovarian cancer
Mullerian tumors
peritoneal cavity carcinoma
gastrointestinal tract tumor

GI tract tumor
pancreatic cancer
colon cancer

Study placed in the following topic categories:

Ovarian Neoplasms
Digestive System Neoplasms
Pancreatic Neoplasms
Antimitotic Agents
Abdominal Neoplasms
Carcinoma
Digestive System Diseases

Paclitaxel
Peritoneal Diseases
Tubulin Modulators
Gastrointestinal Neoplasms
Ovarian Cancer
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Abdominal Neoplasms
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Digestive System Diseases
Paclitaxel
Therapeutic Uses
Peritoneal Diseases
Tubulin Modulators
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009