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

Primary Purpose

Esophageal Cancer, Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab
Docetaxel
Oxaliplatin
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute
  • Veterans Affairs Medical Center - Detroit
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Docetaxel, Oxaliplatin & Bevacizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Response Rate by RECIST Criteria
Percentage of Participants with response by RECIST criteria until progression
Toxicity Profile
Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading.
Time to Treatment Failure
Time to treatment failure using the Kaplan-Meier method
Overall Survival
Overall survival using the Kaplan-Meier method

Full Information

First Posted
September 20, 2005
Last Updated
March 13, 2019
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00217581
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2004 (Actual)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Docetaxel, Oxaliplatin & Bevacizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.
Primary Outcome Measure Information:
Title
Time to Progression
Description
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
Time Frame
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 Outcome Measure Information:
Title
Response Rate by RECIST Criteria
Description
Percentage of Participants with response by RECIST criteria until progression
Time Frame
After every 2 cycles (1 cycle =21 days)
Title
Toxicity Profile
Description
Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading.
Time Frame
At 21 days following completion of study treatment
Title
Time to Treatment Failure
Description
Time to treatment failure using the Kaplan-Meier method
Time Frame
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
Title
Overall Survival
Description
Overall survival using the Kaplan-Meier method
Time Frame
Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip A. Philip, MD, PhD, FRCP
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Basil El-Rayes, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Veterans Affairs Medical Center - Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.gov/clinicaltrials
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

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

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