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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Philip Philip, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00217581
First received: September 20, 2005
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Biological: Bevacizumab
Drug: Docetaxel
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Bevacizumab, Docetaxel, and Oxaliplatin in Gastric and Gastroesophageal Junction Cancer

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: After every 2 cycles (1 cycle =21 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response Rate by RECIST Criteria Until Progression [ Time Frame: After every 2 cycles (1 cycle =21 days) ] [ Designated as safety issue: No ]
  • Toxicity Profile [ Time Frame: At 21 days following completion of study treatment ] [ Designated as safety issue: Yes ]
  • Time to Treatment Failure [ Time Frame: Every 21 days ] [ Designated as safety issue: No ]
  • Overall Survival [ 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 ] [ Designated as safety issue: No ]
  • Quality of Life by EORTC Quality of Life Questionnaire (QLQ) and QLQ-STO22 for Gastric Cancer [ Time Frame: at baseline and every 14-17 days after day 1 cycle 1 until the completion of the study or until week 26 ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: October 2004
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel, Oxaliplatin & 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.
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.
Other Name: Avastin
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;
Other Name: Taxotere
Drug: Oxaliplatin
Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle.
Other Name: Eloxatin

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00217581

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Philip A. Philip, MD, PhD, FRCP Barbara Ann Karmanos Cancer Institute
Principal Investigator: Basil El-Rayes, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Philip Philip, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00217581     History of Changes
Other Study ID Numbers: CDR0000441641, P30CA022453, WSU-D-2840, UMCC-2005-052, AVENTIS-WSU-D-2840
Study First Received: September 20, 2005
Results First Received: June 5, 2014
Last Updated: June 5, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
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

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Bevacizumab
Docetaxel
Oxaliplatin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 20, 2014