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

Completed · Phase 1

Conditions studied: Ovarian Cancer, Peritoneal Cavity Cancer, Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID: NCT00825201
Run by: City of Hope Medical Center
People needed: 27
Starts: 2009-01-01
Expected to finish: 2018-01-16
Last updated by the study team: 2018-01-19

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

City of Hope Medical Center — Duarte, California, United States
Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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