Brief Summary

Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of combining bortezomib with carboplatin and etoposide in treating patients who have advanced solid tumors that have not responded to previous treatment

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2001

Completed

25 days until next milestone

Study Start

First participant enrolled

January 1, 2002

Completed

1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed

Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

4 years

First QC Date

December 7, 2001

Last Update Submit

February 6, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (2)

MTD defined as the dose level below the dose level that results in DLT in >= 2 of 6 new patients assessed using NCI CTC version 2.0
21 days
Biological data
The variation of these samples as a function of dose and time will be analyzed to define the mathematical function (e.g. linear, exponential, logistic) that best fits and models the data.
Up to 4 years

Study Arms (1)

Treatment (bortezomib, carboplatin, and etoposide)

EXPERIMENTAL

Patients receive bortezomib IV on days 1 and 8, carboplatin IV over 30 minutes on day 1, and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Drug: bortezomibDrug: carboplatinDrug: etoposideOther: laboratory biomarker analysisOther: pharmacological study