Esophageal Cancer Clinical Trial

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

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 carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with oxaliplatin and docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with oxaliplatin and docetaxel works in treating patients with locally advanced unresectable or metastatic stomach or gastroesophageal junction cancer.

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Full Description

OBJECTIVES:

Primary

Determine the time to progression in patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma treated with bevacizumab, oxaliplatin, and docetaxel.

Secondary

Determine the response rate in patients treated with this regimen.
Determine the toxic effects of this regimen in these patients.
Determine time to treatment failure and overall survival of patients treated with this regimen.
Determine the changes in general and disease-specific quality of life, in terms of response to treatment, in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 120 minutes, and docetaxel IV over 60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 18-23 months.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

39

Study ID:

NCT00217581

Recruitment Status:

Completed

Sponsor:

Barbara Ann Karmanos Cancer Institute

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There are 3 Locations for this study

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University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Veterans Affairs Medical Center - Detroit
Detroit Michigan, 48201, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus Ohio, 43210, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

39

Study ID:

NCT00217581

Recruitment Status:

Completed

Sponsor:


Barbara Ann Karmanos Cancer Institute

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