Clinical trial NCT00074009: Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: recurrent gastric cancer
stage III gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-12-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Jamaica
country: United States
facility: Queens Cancer Center of Queens Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Manish A. Shah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Gary K. Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.