Intraperitoneal Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Cancer of the Peritoneal Cavity - Full Text View

Sponsor:	City of Hope Medical Center
Collaborators:	National Cancer Institute (NCI) National Comprehensive Cancer Network
Information provided by (Responsible Party):	City of Hope Medical Center
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 1

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase I Trial of Intraperitoneal Nab-Paclitaxel (Abraxane) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:

Maximum tolerated dose [ Time Frame: 28 days following the first course of treatment in which 2 or more patients experience a Dose Limiting Toxicity ] [ Designated as safety issue: Yes ]
Toxicities [ Time Frame: 28 days following the last course of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response [ Time Frame: 4 weeks after completion of the last course of treatment ] [ 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)

Intervention Details:

nab-paclitaxel administered intraperitoneally on days 1, 8 and 15 of a 28 day cycle. Dose escalation: Level 1- 35 mg/m2/dose, Level 2- 70 mg/m2/dose and Level 3- 90 mg/m2/dose

Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion.

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 Medical Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Medical Center 800-826-4673 becomingapatient@coh.org

Sponsors and Collaborators

City of Hope Medical Center

National Cancer Institute (NCI)

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00825201 History of Changes
Other Study ID Numbers:	08059, P30CA033572, CHNMC-08059, ABRAXIS-CHNMC-08059, NCCN-A02, CDR0000632797
Study First Received:	January 16, 2009
Last Updated:	December 7, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:

peritoneal carcinomatosis
peritoneal cavity cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Ovarian Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms

Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 24, 2012