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

NCT ID: NCT00074009

Last Updated: 2012-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31

Brief Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

Detailed Description

OBJECTIVES:

Primary

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

Secondary

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

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.

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

Conditions

Gastric Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bortezomib

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

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/mm^3
• Absolute neutrophil count at least 1,000/mm^3
• Platelet count at least 100,000/mm^3

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Manish A. Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Gary K. Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Queens Cancer Center of Queens Hospital

Jamaica, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Countries

United States

References

Shah MA, Power DG, Kindler HL, Holen KD, Kemeny MM, Ilson DH, Tang L, Capanu M, Wright JJ, Kelsen DP. A multicenter, phase II study of bortezomib (PS-341) in patients with unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma. Invest New Drugs. 2011 Dec;29(6):1475-81. doi: 10.1007/s10637-010-9474-7. Epub 2010 Jun 25.

Reference Type: RESULT

PMID: 20574790 (View on PubMed)

Other Identifiers

MSKCC-03101

Identifier Type: -

Identifier Source: secondary_id

NCI-6003

Identifier Type: -

Identifier Source: secondary_id

CDR0000341565

Identifier Type: -

Identifier Source: org_study_id