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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Genentech, Inc. | INDUSTRY |
This study is being done to find out what effects a drug named/called bevacizumab has on patients and patients' tumors when given together with standard chemotherapy drugs. Making new blood vessels seems to be important for many tumors to grow. Bevacizumab is a new type of treatment for cancer that blocks the growth of new tumor blood vessels. In this study, the researchers will combine bevacizumab with chemotherapy drugs that are standard for the patient's disease and include cisplatin, docetaxel, fluorouracil, and leucovorin. The way the original combination of cisplatin, docetaxel, and fluorouracil was given caused many side effects including gastrointestinal symptoms, weakness, and a drop in the blood count of infection fighting cells. For this study, the researchers have modified this combination to give lower doses of the medicines more often, to reduce side effects from the chemotherapy. Patients will receive bevacizumab with this modified combination of docetaxel, cisplatin, and fluorouracil. This study is called a phase II study. In this study, everyone will have similar tumors and receive the same treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin | Experimental | Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin | Drug | Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Month Progression Free Survival | as measured from the start of the treatment to the date of either documentation of disease progression or death. As we have previously, we will define progression of disease as per RECIST criteria. As per RECIST criteria, any evidence of progression in non-measurable lesions, measurable lesions, or the development of new lesions, would qualify as disease progression .RECIST criteria as defined by CTEP (http://ctep.info.nih.gov/Policies). | 6 months |
| 1-year Survival | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Measurable Disease the Confirmed Response Rate | up to 2 years |
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Inclusion Criteria:
Patients must have histologically or cytologically confirmed metastatic or unresectable gastric or esophageal adenocarcinoma, including GEJ adenocarcinoma which will be classified according to Siewert's classification type I, II, or III.
Histological documentation of local recurrence or metastasis is strongly encouraged, unless the risk of such a procedure outweighs the potential benefit of confirming the metastatic disease.
If no histologic confirmation, then the metastases or recurrence will require documentation by a 2nd radiographic procedure (i.e. positron emission tomography [PET] scan or magnetic resonance imaging [MRI] in addition to the computed tomography [CT] scan). If the imaging procedure does not confirm recurrent or metastatic disease, biopsy confirmation will be required.
Patients must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease. Measurable disease is defined as that which can be measured in at least one dimension as > or = 20 mm with conventional techniques, or > or = 10 mm by high resolution imaging. Disease that is identified on radiology studies, but does not meet the criteria for measurable disease, is considered non-measurable - see section 12.1.1 of protocol for further details.
No prior chemotherapy for metastatic or unresectable disease. Patients may have received prior adjuvant therapy (chemotherapy and/or chemoradiation) if more than 6 months have elapsed between the end of adjuvant therapy and registration. Patients may not have received prior docetaxel or cisplatin, or bevacizumab or any other novel biologic anti-angiogenic agent.
Age 18 years or older.
Karnofsky performance status > or = 70% (ECOG performance status 0-1).
Peripheral neuropathy < or = grade 1
Hematologic (minimal values):
Hepatic (minimal values):
Kidney function (minimal values):
The patient has a PT (INR) < or = 1.5 and a PTT < or = 3 seconds above the upper limits of normal if the patient is not on anticoagulation therapy. If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
Women of childbearing potential must have a negative pregnancy test. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Ability to understand informed consent and signing of written informed consent document prior to initiation of protocol therapy.
Exclusion Criteria:
Patients who have received previous chemotherapy for the treatment of metastatic or unresectable gastric, GEJ, or esophageal adenocarcinoma are ineligible. Patients who have received previous pre- or post-operative chemotherapy or chemoradiation are ineligible if therapy was completed less than 6 months prior to study registration. Patients must have recovered from adverse events from any previous therapy.
Patients who have received previous bevacizumab, docetaxel, or cisplatin.
Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
Patients with brain or central nervous system metastases, including leptomeningeal disease.
Minor surgical procedure such as fine needle aspiration, core biopsy, laparoscopy, or mediport placement within 7 days prior to initiating treatment.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0
Anticipation of need for major surgical procedure during the course of the study.
Pregnant (positive pregnancy test) or breast feeding.
Urine protein:creatinine (Up/c) ratio > or = 1.0 at screening
History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to the initiation of treatment.
Serious, non-healing wound, ulcer, or bone fracture.
Blood pressure > 150/100 mmHg
Significant cardiac disease defined as:
Evidence of bleeding diathesis or coagulopathy.
History of a stroke or cerebrovascular accident (CVA) within 6 months.
Clinically significant peripheral vascular disease.
Clinically significant hearing loss or ringing in the ears.
Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
Inability to comply with study and/or follow-up procedures.
Patients with any other medical condition or reason, in the investigator's opinion, that makes the patient unstable to participate in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| David Ilson, MD,PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memoral Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States | |||
| Memorial Sloan-Kettering Cancer Center @ Suffolk |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin | Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin: Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan-Kettering Cancer Center 1275 York Avenue | New York | New York | 10021 | United States |
| Memorial Sloan-Kettering Cancer Center at Mercy Medical Center | Rockville Centre | New York | 11570 | United States |
| Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital | Sleepy Hollow | New York | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin | Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | 6 Month Progression Free Survival | as measured from the start of the treatment to the date of either documentation of disease progression or death. As we have previously, we will define progression of disease as per RECIST criteria. As per RECIST criteria, any evidence of progression in non-measurable lesions, measurable lesions, or the development of new lesions, would qualify as disease progression .RECIST criteria as defined by CTEP (http://ctep.info.nih.gov/Policies). | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Patients With Measurable Disease the Confirmed Response Rate | Posted | Number | 95% Confidence Interval | percentage of participants | up to 2 years |
|
| ||||||||||||||||||||||||||||
| Primary | 1-year Survival | Posted | Median | 95% Confidence Interval | months | 1 year |
|
|
|
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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, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin | Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes | 27 | 48 | 44 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Death not assoc w CTCAE term-Disease prog NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection, other | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis-Oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Rectal obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest pain-cardiac | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophageal perforation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastric perforation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelet count decrease | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss/alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis-Oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Ilson | Memorial Sloan Kettering Cancer Center | 646-888-4183 | ilsond@mskcc.org |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D000068258 | Bevacizumab |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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| Title | Denominators | Categories |
|---|
| Confirmed Response Rate |
| |||||
| Response Rate (proximal/GEJ tumors) |
|
| Categories |
|---|
| Progression Free Survival |
| |||||
| Overall Survival |
|