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Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer

Primary Purpose

Gastric Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
fluorouracil
leucovorin calcium
Sponsored by
California Cancer Consortium
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 IV gastric cancer, adenocarcinoma of the stomach

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Diagnosis of gastric or gastroesophageal junction adenocarcinoma Metastatic or unresectable disease Progressive disease after receiving 1 prior chemotherapy regimen for metastatic disease comprising 1 of the following: Fluorouracil Cisplatin and irinotecan Capecitabine Taxanes Measurable disease No esophageal cancer No brain metastases PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy At least 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No acute ischemia by EKG No significant conduction abnormality by EKG, including either of the following: Bifasicular block, defined as left anterior hemiblock in the presence of right bundle branch block Second or third degree atrioventricular block No history of cardiac or cerebrovascular disease due to hypotension and tachycardia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception before, during, and for 6 months after study participation No ongoing or active infection No other uncontrolled illness No peripheral neuropathy ≥ grade 2 within the past 2 weeks No allergy to boron or mannitol PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior immunotherapy Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy and recovered Surgery More than 2 weeks since prior major surgery Other No concurrent highly active anti-retroviral therapy for HIV-positive patients No other concurrent investigational agents

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • City of Hope Medical Group
  • University of California Davis Cancer Center
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

Outcomes

Primary Outcome Measures

Response rate as measured by RECIST every 8 weeks

Secondary Outcome Measures

Time to progression every 8 weeks
Overall survival
Toxicity every 4 weeks
Molecular correlates on and off study treatment

Full Information

First Posted
February 7, 2005
Last Updated
October 11, 2010
Sponsor
California Cancer Consortium
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00103103
Brief Title
Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer
Official Title
A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Terminated
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
California Cancer Consortium
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer.
Detailed Description
OBJECTIVES: Primary Determine response in patients with previously treated metastatic or unresectable gastric or gastroesophageal junction adenocarcinoma treated with bortezomib, fluorouracil, and leucovorin calcium. Secondary Determine time to progression and overall survival of patients treated with this regimen. Determine the toxic effects of this regimen in these patients. OUTLINE: This is a non-randomized, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. One hour after completion of bortezomib, patients receive leucovorin calcium IV and fluorouracil IV followed by fluorouracil IV continuously over 46 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for survival. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.

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 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
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Primary Outcome Measure Information:
Title
Response rate as measured by RECIST every 8 weeks
Secondary Outcome Measure Information:
Title
Time to progression every 8 weeks
Title
Overall survival
Title
Toxicity every 4 weeks
Title
Molecular correlates on and off study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of gastric or gastroesophageal junction adenocarcinoma Metastatic or unresectable disease Progressive disease after receiving 1 prior chemotherapy regimen for metastatic disease comprising 1 of the following: Fluorouracil Cisplatin and irinotecan Capecitabine Taxanes Measurable disease No esophageal cancer No brain metastases PATIENT CHARACTERISTICS: Age Over 18 Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy At least 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal Renal Creatinine ≤ 1.5 mg/dL Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No acute ischemia by EKG No significant conduction abnormality by EKG, including either of the following: Bifasicular block, defined as left anterior hemiblock in the presence of right bundle branch block Second or third degree atrioventricular block No history of cardiac or cerebrovascular disease due to hypotension and tachycardia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception before, during, and for 6 months after study participation No ongoing or active infection No other uncontrolled illness No peripheral neuropathy ≥ grade 2 within the past 2 weeks No allergy to boron or mannitol PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior immunotherapy Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy and recovered Surgery More than 2 weeks since prior major surgery Other No concurrent highly active anti-retroviral therapy for HIV-positive patients No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz-Josef Lenz, MD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
Country
United States
Facility Name
City of Hope Medical Group
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer

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