NCT00030368

Brief Summary

Phase I trial to study the effectiveness of combining bortezomib with paclitaxel in treating patients who have advanced or metastatic solid tumors. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with paclitaxel may kill more tumor cells.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

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

November 1, 2001

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

7.3 years

First QC Date

February 14, 2002

Last Update Submit

June 3, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (3)

  • Dose-limiting toxicity (DLT) defined as Common Terminology Criteria (CTC) version 2.0 grade 3 or greater non-hematologic toxicity or grade 4 hematologic toxicity with the exception of asymptomatic neutropenia [ANC < 500]

    21 days

  • Maximum-tolerated dose (MTD) based on the incidence of DLT

    21 days

  • Dose of PS-341 that results in not more than 70% to 80% 20S proteasome inhibition [20S-PI] in combination with a paclitaxel

    At baseline and at 1 hour of weeks 1, 2 and 4

Secondary Outcomes (5)

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

    Up to 21 days

  • Change in the level of p27 and Bax proteins in peripheral blood mononuclear cells

    From baseline to 6 hours of day 1 (week 1) and day 2 (week 2)

  • Change in plasma levels of TNF, IL-1, IL-6, and C-reactive protein

    From baseline to 6 hours of day 2 (weeks 1 and 2)

  • Change in NF-kb biomarkers TRAP I and c-IAP-2 in tumor tissue blocks

    From baseline to 6 hours of day 2 (weeks 1 and 2)

  • Change in phosphorylation of c-Jun and JNK in tumor tissue blocks

    From baseline to 6 hours of day 2 (weeks 1 and 2)

Study Arms (1)

Treatment (bortezomib, paclitaxel)

EXPERIMENTAL

Patients receive bortezomib IV on days 2 and 9 and paclitaxel IV over 1 hour on days 1 and 8. For the first course only, patients do not receive paclitaxel on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Drug: bortezomibDrug: paclitaxelOther: laboratory biomarker analysis

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Treatment (bortezomib, paclitaxel)
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Treatment (bortezomib, paclitaxel)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (bortezomib, paclitaxel)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed locally advanced or metastatic solid tumor for which there is no curative treatment
  • No known brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • WBC at least 3,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN)
  • Creatinine no greater than ULN
  • Left ventricular function at least lower limit of normal if received prior doxorubicin
  • No grade II or IV tilt-table test
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

BortezomibPaclitaxelTaxes

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesEconomicsHealth Care Economics and Organizations

Study Officials

  • Charles Shapiro

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 14, 2002

First Posted

April 9, 2003

Study Start

November 1, 2001

Primary Completion

February 1, 2009

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)