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Intraperitoneal Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Cancer of the Peritoneal Cavity
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
First Received: January 16, 2009   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
National Comprehensive Cancer Network
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00825201
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle formulation directly into the abdomen may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced cancer of the peritoneal cavity.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Other: liquid chromatography
Other: mass spectrometry
Other: pharmacological study
Phase I

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Trial of Intraperitoneal Nab-Paclitaxel (Abraxane) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Toxicities [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2008
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation in patients with advanced malignancies primarily confined to the peritoneal cavity.

Secondary

  • To evaluate the pharmacokinetics and potential pharmacokinetic advantage of this drug in these patients.

OUTLINE: Patients receive intraperitoneal paclitaxel albumin-stabilized nanoparticle formulation on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Plasma and peritoneal fluid samples are collected periodically for pharmacokinetic analysis by liquid chromatography and mass spectometry.

After completion of study treatment, patients are followed for 4 weeks.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced cancer primarily confined to the peritoneal cavity

    • Refractory to chemotherapy OR disease for which no "standard" chemotherapeutic regimen exists
  • Patients with ovarian cancer who have residual disease at second-look laparotomy or following secondary debulking (performed 4-6 weeks ago) are eligible
  • Measurable disease allowed but not required
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Life expectancy > 3 months
  • Leukocytes > 3,000/mm^3
  • ANC > 1,500/mm^3
  • Platelet count > 100,000/mm^3
  • Total bilirubin normal
  • AST/ALT < 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance > 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situations that would limit compliance with study requirements
  • No ongoing abdominal infections or bowel obstruction
  • No known peritoneal adhesions
  • No pre-existing sensory neuropathy ≥ grade 2
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel albumin-stabilized nanoparticle formulation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior surgery
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
  • Prior taxanes allowed
  • Prior intraperitoneal chemotherapy allowed provided it was not complicated by peritoneal adhesions
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825201

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen     800-826-4673     becomingapatient@coh.org    
Sponsors and Collaborators
Beckman Research Institute
National Comprehensive Cancer Network
Investigators
Principal Investigator: Mihaela Cristea, MD Beckman Research Institute
Study Chair: Mihaela Cristea, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Comprehensive Cancer Center ( Mihaela Cristea )
Study ID Numbers: CDR0000632797, CHNMC-08059, ABRAXIS-CHNMC-08059, NCCN-A02
Study First Received: January 16, 2009
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00825201     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
peritoneal carcinomatosis
peritoneal cavity cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Ovarian Neoplasms
Digestive System Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Ovarian Epithelial Cancer
Abdominal Neoplasms
Recurrence
Genital Diseases, Female
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Gonadal Disorders
Antineoplastic Agents
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Antimitotic Agents
Abdominal Neoplasms
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Peritoneal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009