NCT00825201

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 ovarian-cancer

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1 ovarian-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2018

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

9 years

First QC Date

January 16, 2009

Last Update Submit

January 17, 2018

Conditions

Ovarian CancerPeritoneal Cavity CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

peritoneal carcinomatosisperitoneal cavity cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • Dose-limiting toxicities as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and maximum-tolerated dose

    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 Outcomes (1)

  • Response according to Response Evaluation Criteria in Solid Tumors (RECIST)

    4 weeks after completion of the last course of treatment

Other Outcomes (2)

  • Pharmacokinetic (area under the curve [AUC], pharmacological advantage, and clearance in the plasma and peritoneum)

    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)

    Course 1 days 1 and 15 at 1, 2, 4, 8, 12, 24 and 48 hours

Study Arms (1)

Treatment (paclitaxel albumin-stabilized nanoparticle)

EXPERIMENTAL

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.

Drug: paclitaxel albumin-stabilized nanoparticle formulationOther: liquid chromatographyOther: mass spectrometryOther: pharmacological studyOther: laboratory biomarker analysis

Interventions

paclitaxel albumin-stabilized nanoparticle formulationDRUG

Given IP

Also known as: ABI-007, nab paclitaxel, nab-paclitaxel, nanoparticle albumin-bound paclitaxel
Treatment (paclitaxel albumin-stabilized nanoparticle)
liquid chromatographyOTHER

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.

Treatment (paclitaxel albumin-stabilized nanoparticle)
mass spectrometryOTHER

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.

Treatment (paclitaxel albumin-stabilized nanoparticle)
pharmacological studyOTHER

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.

Treatment (paclitaxel albumin-stabilized nanoparticle)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (paclitaxel albumin-stabilized nanoparticle)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Cristea MC, Frankel P, Synold T, Rivkin S, Lim D, Chung V, Chao J, Wakabayashi M, Paz B, Han E, Lin P, Leong L, Hakim A, Carroll M, Prakash N, Dellinger T, Park M, Morgan RJ. A phase I trial of intraperitoneal nab-paclitaxel in the treatment of advanced malignancies primarily confined to the peritoneal cavity. Cancer Chemother Pharmacol. 2019 Mar;83(3):589-598. doi: 10.1007/s00280-019-03767-9. Epub 2019 Jan 8.

    PMID: 30623229DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsPeritoneal NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

TaxesAlbumin-Bound Paclitaxel130-nm albumin-bound paclitaxelChromatography, LiquidMass Spectrometry

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersAbdominal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and OrganizationsPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsChromatographyChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Mihaela Cristea, MD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

  • Mihaela Cristea, MD

    City of Hope Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 19, 2009

Study Start

January 1, 2009

Primary Completion

January 16, 2018

Study Completion

January 16, 2018

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

US(2)