Bortezomib and Docetaxel in Treating Patients With Advanced Solid Tumors

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00049088
Phase
PHASE1
Status
Terminated

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • docetaxel — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

Phase I trial to study the effectiveness of combining bortezomib with docetaxel in treating patients who have advanced solid tumors. Bortezomib 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 bortezomib with docetaxel may kill more tumor cells

Key Dates

First listed
Jan 27, 2003
Start date
Aug 31, 2002
Status verified
Jan 2013
Primary completion
Feb 28, 2009

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (docetaxel, bevacizumab)
    For course 1, patients receive docetaxel IV over 1 hour on days 1 and 8 and bortezomib IV over 3-5 seconds on days 9 and 12. Patients then receive 1 week of rest. For course 2 and all subsequent courses, patients receive docetaxel on days 1 and 8 and bortezomib on days 2, 5, 9, and 12. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 2-6 patients receive escalating doses of bortezomib and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.

Primary Outcome Measure

Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT) as assessed by the NCI Common Toxicity Criteria (CTC) version 2.0 [ Time Frame: 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287-8936-

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By research site
Johns Hopkins University· Baltimore, MD

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