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Status:

COMPLETED

Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer

Lead Sponsor:

Barbara Ann Karmanos Cancer Institute

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Esophageal Cancer

Gastric Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and kill them or carr...

Detailed Description

OBJECTIVES: Primary * Determine the time to progression in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma treated with bevacizumab, oxa...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed gastric or gastroesophageal junction adenocarcinoma
  • Locally advanced unresectable or metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10mm by spiral CT scan
  • Bone metastases, ascites, or pleural effusions are not considered measurable disease
  • Evaluable disease must be present outside previously irradiated field
  • No CNS or brain metastases
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • SWOG 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 10 mg/dL
  • No evidence of bleeding diathesis or coagulopathy
  • Hepatic
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ ULN
  • INR \< 1.5
  • Renal
  • Creatinine \< 2.0 mg/dL
  • Urine protein:creatinine ratio \< 1.0
  • Cardiovascular
  • No history of deep venous thrombosis requiring anticoagulation
  • No active angina
  • No myocardial infarction within the past year
  • No cerebrovascular accident within the past year
  • No uncontrolled hypertension (systolic blood pressure \[BP\] \> 170 mm Hg and/or diastolic BP \> 100 mm Hg) despite medical management
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • No peripheral neuropathy \> grade 1
  • No history of allergy to any of the study drugs or drugs formulated with polysorbate 80
  • No known HIV infection
  • No active peptic ulcer disease
  • No serious non-healing wound, ulcer, or bone fracture
  • No unresolved bacterial infection requiring antibiotics
  • No other active malignancy within the past 3 years except for cancers that have been treated with a curative intent
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent immunotherapy
  • Chemotherapy
  • No prior chemotherapy for gastric cancer unless disease relapsed \> 6 months after completion of non-taxane adjuvant chemotherapy
  • No other concurrent chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • At least 3 weeks since radiotherapy
  • Surgery
  • At least 4 weeks since prior surgery or open biopsy (except indwelling venous catheter placement)
  • No concurrent surgery
  • Other
  • At least 4 weeks since prior and no concurrent participation in another experimental drug trial
  • No concurrent full-dose anticoagulation
  • No concurrent experimental drugs

Exclusion

    Key Trial Info

    Start Date :

    October 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2013

    Estimated Enrollment :

    39 Patients enrolled

    Trial Details

    Trial ID

    NCT00217581

    Start Date

    October 1 2004

    End Date

    January 1 2013

    Last Update

    March 26 2019

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, United States, 48109-0942

    2

    Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, United States, 48201-1379

    3

    Veterans Affairs Medical Center - Detroit

    Detroit, Michigan, United States, 48201

    4

    Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

    Columbus, Ohio, United States, 43210-1240