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Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

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Trial Information

Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Time Frame:

After every 2 cycles (1 cycle =21 days)

Safety Issue:

No

Principal Investigator

Philip A. Philip, MD, PhD, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000441641

NCT ID:

NCT00217581

Start Date:

October 2004

Completion Date:

January 2013

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • recurrent gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • recurrent esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • adenocarcinoma of the stomach
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240