Clinical trial NCT00217581: Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer
Official title: Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: 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
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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, 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.

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

Primary outcomes:
measure: Time to Progression
timeFrame: After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Secondary outcomes:
measure: Response Rate by RECIST Criteria
timeFrame: After every 2 cycles (1 cycle =21 days)
measure: Toxicity Profile
timeFrame: At 21 days following completion of study treatment
measure: Time to Treatment Failure
timeFrame: Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
measure: Overall Survival
timeFrame: Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Veterans Affairs Medical Center - Detroit
state: Michigan
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Philip A. Philip, MD, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Barbara Ann Karmanos Cancer Institute
name: Basil El-Rayes, MD
role: PRINCIPAL_INVESTIGATOR
References: