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

This study has been terminated.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
California Cancer Consortium
ClinicalTrials.gov Identifier:
NCT00103103
First received: February 7, 2005
Last updated: October 11, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
 Drug: bortezomib
Drug: fluorouracil
Drug: leucovorin calcium
 Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by California Cancer Consortium:

Primary Outcome Measures:
  • Response rate as measured by RECIST every 8 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression every 8 weeks [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity every 4 weeks [ Designated as safety issue: Yes ]
  • Molecular correlates on and off study treatment [ Designated as safety issue: No ]

Study Start Date: March 2005
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103103

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
City of Hope Medical Group
Pasadena, California, United States, 91105
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
California Cancer Consortium
National Cancer Institute (NCI)
Investigators
Study Chair: Heinz-Josef Lenz, MD USC/Norris Comprehensive Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00103103     History of Changes
Other Study ID Numbers: CDR0000410827, CCC-PHII-43, NCI-5991, LAC-USC-3G036
Study First Received: February 7, 2005
Last Updated: October 11, 2010
Health Authority: United States: Federal Government

Keywords provided by California Cancer Consortium:
recurrent gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach

Additional relevant MeSH terms:
Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorouracil
Bortezomib
Leucovorin
 Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on June 18, 2013