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A Phase I Study of PS-341 in Combination With Paclitaxel in Metastatic Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of PS-341 in Combination With Paclitaxel in Metastatic Solid Tumors


PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose of bortezomib when given in combination with
paclitaxel in patients with locally advanced or metastatic solid tumors.

OUTLINE: This is a multicenter, dose-escalation study of bortezomib.

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.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity or greater than 80% 20S proteasome
inhibition. Once the MTD is determined, an additional 6-9 patients are accrued and treated
at that dose.

Patients are followed at 21 days.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.


Inclusion Criteria:



- 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

- No thrombotic event within the past 6 months

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior allergic reaction to compounds of similar chemical or biological composition
to study drugs

- No other concurrent uncontrolled illness

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- Prior paclitaxel allowed

- At least 2 weeks since prior hormonal therapy

- No concurrent steroids or hormonal therapy except steroids to prevent
hypersensitivity reactions to paclitaxel or hormonal therapy for non-disease-related
conditions (e.g., insulin for diabetes)

- At least 4 weeks since prior radiotherapy

- At least 4 weeks since prior surgery

- Recovered from prior therapy

- No other concurrent investigational agents

- No concurrent combination anti-retroviral therapy for HIV-positive patients

- No concurrent anticoagulation therapy

- Concurrent pamidronate or zoledronate allowed for treatment of hypercalcemia or for
palliation of skeletal metastases

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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]

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Charles Shapiro

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01408

NCT ID:

NCT00030368

Start Date:

November 2001

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location

Ohio State University Medical CenterColumbus, Ohio  43210