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

January 17, 2018 updated by: City of Hope Medical Center

Phase I Trial of Intraperitoneal Nab-Paclitaxel (Abraxane) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of nab-paclitaxel as a single agent administered intraperitoneally via an intraperitoneal catheter.

SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetics of nab-paclitaxel (Abraxane) in the plasma and peritoneum when it is administered directly into the peritoneal cavity. II. To determine the potential pharmacokinetic advantage (favorable ratio of nab-paclitaxel (Abraxane) concentration in the peritoneal cavity vs. plasma) for nab-paclitaxel administered intraperitoneally. III. To determine the progression of peripheral neuropathy in patients treated with intraperitoneal chemotherapy on this study through pre-treatment and sequential evaluation of the Neuropathic Pain Syndrome Inventory and Serial Nerve Conduction Studies.

OUTLINE: This is a dose-escalation study. Patients receive paclitaxel albumin-stabilized nanoparticle formulation given intraperitoneally (IP) on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have histological confirmed advanced cancer primarily confined to the peritoneal cavity which have progressed on previous chemotherapeutic regimens, or for which no "standard" chemotherapeutic regimens exist
  • Prior taxane exposure is allowed; prior IP chemotherapy is allowed, if it was not complicated by peritoneal adhesions; patients with ovarian cancer having residual disease at second-look laparotomy or following secondary debulking are also eligible; patients must be 4-6 weeks after surgery and they must have recovered from the surgery prior to initiating IP chemotherapy
  • Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
  • Life expectancy of greater than 3 months
  • Absolute neutrophil count > 1,500/mcL
  • Platelets > 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 2.5 x institutional upper limit of normal
  • Creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Documentation of measurable disease (with baseline measurements taken with 4 weeks of study entry, when present and appropriate); presence of measurable disease is not, per se, a prerequisite for entry onto this study
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administer more than 4 weeks earlier; there is no limit on the number of prior lines of chemotherapy
  • Patients may not be receiving any other investigational agents
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-paclitaxel
  • Patients with ongoing abdominal infections or bowel obstruction
  • Patients with known peritoneal adhesions that preclude the placement of an intraperitoneal catheter in the opinion of the surgeon placing the intraperitoneal catheter
  • Pre-existing grade >= 2 sensory neuropathy
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with nab-paclitaxel
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
  • "Massive Ascites" requiring therapeutic paracentesis, will not be cause for ineligibility, per se, it will be evaluated on an individual basis; investigators who have any questions regarding assessing ascites are asked to speak with the Principal Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment (paclitaxel albumin-stabilized nanoparticle)
Patients receive paclitaxel albumin-stabilized nanoparticle formulation given IP on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Correlative studies
Drug: paclitaxel albumin-stabilized nanoparticle formulation
Given IP
Other Names:
  • ABI-007
  • nab-paclitaxel
  • nab paclitaxel
  • nanoparticle albumin-bound paclitaxel
Other: liquid chromatography
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.
Other: mass spectrometry
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.
Other: pharmacological study
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-limiting toxicities as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and maximum-tolerated dose
Time Frame: 28 days following the first course of treatment in which 2 or more patients experience a Dose Limiting Toxicity
The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by CTCAE and nadir or maximum values for the laboratory measures), time of onset (i.e., course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and course.
28 days following the first course of treatment in which 2 or more patients experience a Dose Limiting Toxicity

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response according to Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: 4 weeks after completion of the last course of treatment
All responses will be reported; because of the potential heterogeneity of the patients, no attempt will be made to estimate the response rate.
4 weeks after completion of the last course of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (area under the curve [AUC], pharmacological advantage, and clearance in the plasma and peritoneum)
Time Frame: Course 1 days 1 and 15 at 1, 2, 4, 6, 8, 12, 24, and 48 hours
Will be summarized by dose level with simple summary statistics: means (possibly after transformation) or medians, ranges, and standard deviations (if numbers and distribution permit).
Course 1 days 1 and 15 at 1, 2, 4, 6, 8, 12, 24, and 48 hours
Pharmacodynamic (AUC, pharmacological advantage, and clearance in the plasma and peritoneum)
Time Frame: Course 1 days 1 and 15 at 1, 2, 4, 8, 12, 24 and 48 hours
Will be summarized by dose level with simple summary statistics: means (possibly after transformation) or medians, ranges, and standard deviations (if numbers and distribution permit).
Course 1 days 1 and 15 at 1, 2, 4, 8, 12, 24 and 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)
National Comprehensive Cancer Network

Investigators

  • Principal Investigator: Mihaela Cristea, MD, City of Hope Comprehensive Cancer Center
  • Study Chair: Mihaela Cristea, MD, City of Hope Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

January 16, 2018

Study Completion (ACTUAL)

January 16, 2018

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (ESTIMATE)

January 19, 2009

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08059
  • CHNMC-08059
  • ABRAXIS-CHNMC-08059
  • NCCN-A02
  • CDR0000632797 (REGISTRY: NCI PDQ)
  • NCI-2010-00921 (REGISTRY: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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