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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00217581
Other study ID # CDR0000441641
Secondary ID P30CA022453WSU-D
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2004
Est. completion date January 2013

Study information

Verified date March 2019
Source Barbara Ann Karmanos Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date January 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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 Design


Intervention

Biological:
Bevacizumab
Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.
Drug:
Docetaxel
Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;
Oxaliplatin
Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Progression Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions 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 Response Rate by RECIST Criteria Percentage of Participants with response by RECIST criteria until progression After every 2 cycles (1 cycle =21 days)
Secondary Toxicity Profile Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading. At 21 days following completion of study treatment
Secondary Time to Treatment Failure Time to treatment failure using the Kaplan-Meier method 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
Secondary Overall Survival Overall survival using the Kaplan-Meier method Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years
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