NCT00028587

Brief Summary

Phase I trial to study the effectiveness of combining PS-341 and combination chemotherapy in treating patients who have advanced solid tumors. PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining PS-341 and chemotherapy may kill more tumor cells

Trial Health

80
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at 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

December 1, 2001

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

4.3 years

First QC Date

January 4, 2002

Last Update Submit

January 15, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

  • MTD of paclitaxel, bortezomib, and carboplatin defined as the highest safely-tolerated dose where =< 1 patient experience dose-limiting toxicity (DLT) with the next higher dose having at least 2 patients who experience DLT as assessed by CTC version 2.0

    21 days

  • Number of toxicity incidents as assessed by CTC Version 2.0

    Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.

    21 days

Secondary Outcomes (3)

  • Number of responses

    Up to 3 months

  • Change in p53 accumulation

    From baseline to up to 3 months

  • Change in other proteasome levels

    From baseline to up to 3 months

Study Arms (2)

Group I (paclitaxel, carboplatin, bortezomib)

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and bortezomib IV over 3-5 seconds on days 2, 5, and 8.

Drug: bortezomibDrug: paclitaxelDrug: carboplatinOther: laboratory biomarker analysis

Group II (bortezomib, paclitaxel, carboplatin)

EXPERIMENTAL

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2

Drug: bortezomibDrug: paclitaxelDrug: carboplatinOther: laboratory biomarker analysis

Interventions

bortezomibDRUG

Given IV

Also known as: LDP 341, MLN341, VELCADE
Group I (paclitaxel, carboplatin, bortezomib)Group II (bortezomib, paclitaxel, carboplatin)
paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol
Group I (paclitaxel, carboplatin, bortezomib)Group II (bortezomib, paclitaxel, carboplatin)
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Group I (paclitaxel, carboplatin, bortezomib)Group II (bortezomib, paclitaxel, carboplatin)
laboratory biomarker analysisOTHER

Optional correlative studies

Group I (paclitaxel, carboplatin, bortezomib)Group II (bortezomib, paclitaxel, carboplatin)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed malignancy for which no known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
  • No hematologic malignancies
  • No symptomatic CNS metastases
  • Brain metastases allowed if previously treated (radiotherapy and/or surgery)and patient is stable for at least 8 weeks
  • Performance status - ECOG 0-2
  • At least 12 weeks
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No New York Heart Association class III or IV heart disease
  • HIV negative
  • No peripheral neuropathy grade 2 or greater
  • No uncontrolled infection
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

BortezomibPaclitaxelTaxesCarboplatin

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Alex Adjei

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

December 1, 2001

Primary Completion

April 1, 2006

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)