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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-D-2840 | |||
| UMCC-2005-052 | |||
| AVENTIS-WSU-D-2840 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel, Oxaliplatin & Bevacizumab | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate by RECIST Criteria | Percentage of Participants with response by RECIST criteria until progression | After every 2 cycles (1 cycle =21 days) |
| Toxicity Profile | Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading. |
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DISEASE CHARACTERISTICS:
Histologically confirmed gastric or gastroesophageal junction adenocarcinoma
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10mm by spiral CT scan
No CNS or brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Philip A. Philip, MD, PhD, FRCP | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Basil El-Rayes, MD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States | ||
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Docetaxel | Drug | Must be administered 2nd after Bevacizumab and followed by Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle; |
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| Oxaliplatin | Drug | Must be administered 3rd after Bevacizumab and Docetaxel. 75 mg/m(2), IV over 120 minutes, Day 1 of each cycle. |
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| At 21 days following completion of study treatment |
| 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 |
| 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 |
| Barbara Ann Karmanos Cancer Institute |
| Detroit |
| Michigan |
| 48201-1379 |
| United States |
| Veterans Affairs Medical Center - Detroit | Detroit | Michigan | 48201 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210-1240 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | 95% Confidence Interval | months | 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 |
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| Secondary | Response Rate by RECIST Criteria | Percentage of Participants with response by RECIST criteria until progression | Posted | Number | 95% Confidence Interval | percentage of responders | After every 2 cycles (1 cycle =21 days) |
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| Secondary | Toxicity Profile | Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading. | Posted | Count of Participants | Participants | At 21 days following completion of study treatment |
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| Secondary | Time to Treatment Failure | Time to treatment failure using the Kaplan-Meier method | Posted | Median | 95% Confidence Interval | months | 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 |
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| Secondary | Overall Survival | Overall survival using the Kaplan-Meier method | Posted | Median | 95% Confidence Interval | months | 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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Docetaxel, Oxaliplatin & Bevacizumab | Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; 1st cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins. Bevacizumab: 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 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins. Docetaxel: Must be administered 2nd after Bevacizumab then Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle; | 23 | 39 | 23 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Investigations | CTCAE Version 3.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE Version 3.0 | Systematic Assessment |
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| Late Dehydration | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
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| Gastrointestinal (GI) Perforation (not graded) | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE Version 3.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE Version 3.0 | Systematic Assessment |
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| Fever | General disorders | CTCAE Version 3.0 | Systematic Assessment |
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| Acute Neuropathy | Nervous system disorders | CTCAE Version 3.0 | Systematic Assessment |
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| White Blood Count (WBC) | Investigations | CTCAE Version 3.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | CTCAE Version 3.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE Version (3.0) | Systematic Assessment |
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| Late Diarrhea | Gastrointestinal disorders | CTCAE Version (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE Version (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE Version (3.0) | Systematic Assessment |
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| Acute Neuropathy | Nervous system disorders | CTCAE Version (3.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE Version (3.0) | Systematic Assessment |
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| WBC | Investigations | CTCAE Version (3.0) | Systematic Assessment |
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| Hemoglobin (HGB) | Investigations | CTCAE Version (3.0) | Systematic Assessment |
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| Chronic Neuropathy | Nervous system disorders | CTCAE Version (3.0) | Systematic Assessment |
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The trial completed its planned accrual. There were no significant limitations.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philip A. Philip, M.D., Ph.D., F.R.C.P | Barbara Ann Karmanos Institute | (313) 576-8746 | philipp@karmanos.org |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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