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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00217581
• Other study ID #: CDR0000441641
• Secondary ID: P30CA022453WSU-D
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

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

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database