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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Cancer Research Center
  • Queens Cancer Center of Queens Hospital
  • Memorial Sloan-Kettering Cancer Center
  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 2003
Last Updated
February 11, 2012
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00074009
Brief Title
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

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
recurrent gastric cancer, stage III gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bortezomib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish A. Shah, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary K. Schwartz, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Queens Cancer Center of Queens Hospital
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-3236
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20574790
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.
Results Reference
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Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

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