Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Bortezomib and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	OSU-01H0147 OSU 0158, NCI-1857, NCT00030368, 1857

Objectives

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

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed locally advanced or metastatic solid tumor for which there is no curative treatment



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• Prior paclitaxel allowed

Endocrine therapy:

• 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)

Radiotherapy:

• At least 4 weeks since prior radiotherapy

Surgery:

• At least 4 weeks since prior surgery

Other:

• 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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin normal
• AST/ALT no greater than 2.5 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than ULN

Cardiovascular:

• 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

Other:

• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Charles Shapiro, MD, Protocol chair		Ph: 614-293-6401 Email: charles.shapiro@osumc.edu

Registry Information
Official Title		A Phase I Study of PS-341 in Combination with Paclitaxel in Metastatic Solid Tumors
Trial Start Date		2001-11-16
Trial Completion Date		2009-02-20
Registered in ClinicalTrials.gov		NCT00030368
Date Submitted to PDQ		2001-11-28
Information Last Verified		2007-04-05
NCI Grant/Contract Number		CA16058, CA76576

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