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

Alternate Title

Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI MSKCC-03101 NCI-6003, NCT00074009, 6003

Objectives

Primary

1. Determine the efficacy of bortezomib in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Secondary

1. Determine the toxicity of this drug in these patients.
2. Determine possible predictors of response to this drug, using pretreatment tumor immunohistochemistry, in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
  • Siewert’s class II or III disease



• Measurable disease
  • At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan



• No history of known or active brain metastases or primary brain tumors

Prior/Concurrent Therapy:

Biologic therapy

• More than 3 weeks since prior immunotherapy
• No concurrent biological or immunological agents

Chemotherapy

• No more than 1 prior chemotherapy regimen (including adjuvant chemotherapy)
• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 3 weeks since prior radiotherapy
• No concurrent radiotherapy

Surgery

• Not specified

Other

• Recovered from all prior therapy
• No other concurrent investigational agents
• No other concurrent anticancer agent or therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

  OR

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• Bilirubin no greater than 1.5 mg/dL
• AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• No prior cerebrovascular event
• No prior orthostatic hypotension
• No myocardial infarction within the past 6 months
• No peripheral vascular disease requiring surgical management
• No evidence of acute ischemia or significant conduction abnormality by EKG

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 2 months after study participation
• No evidence of peripheral neuropathy
• No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib
• No other malignancy within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or adequately treated nonmetastatic prostate cancer
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study participation
• No other concurrent uncontrolled illness that would preclude study participation
• No other medical condition or reason that would preclude study participation

Expected Enrollment

A total of 15-33 patients will be accrued for this study within 5-12 months.

Outline

This is an open-label, nonrandomized, multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Manish Shah, MD, Principal investigator		Ph: 212-639-3113; 800-525-2225
Gary K. Schwartz, MD, Principal investigator		Ph: 212-639-8324; 800-525-2225

Registry Information
Official Title		A Multicenter, Open-Label, Two-Stage, Phase II Study Of PS-341 (LDP-341, NSC # 681239) In Patients With Unresectable Or Metastatic Gastric Adenocarcinoma
Trial Start Date		2003-10-16
Registered in ClinicalTrials.gov		NCT00074009
Date Submitted to PDQ		2003-10-21
Information Last Verified		2005-04-06
NCI Grant/Contract Number		P30-CA08748, N01-CM17105

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