Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Time to progression [ Time Frame: After every 2 cycles (1 cycle =21 days) ] [ Designated as safety issue: No ]
- 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. If a subject exeriences a study drug infusion-associated adverse event, the subject may be appropriately premedicated for the nex study drug infusion; however infusion time may not be decreased for the subsequent infusion.
|
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. If a subject exeriences a study drug infusion-associated adverse event, the subject may be appropriately premedicated for the nex study drug infusion; however infusion time may not be decreased for the subsequent infusion.
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 |
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| 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 | |
| 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: | Basil El-Rayes, 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 |
| Last Updated: | February 13, 2013 |
| 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 Diseases Esophageal Neoplasms Stomach Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Stomach Diseases |
Oxaliplatin Docetaxel Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013