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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Weill Medical College of Cornell University | OTHER |
This study is being done to find out how effective a new treatment strategy is on your cancer. In this strategy, the response your tumor has to the first cycle of therapy will help select the next treatments. We also will find out the effects, both good and/or bad, a drug called bevacizumab has on you and your tumor when given with chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Initial chemo for ALL pts (ECX + BEV): Epirubicin 50 mg/m2 d1 every 21 days Cisplatin 60 mg/m2 d1 every 21 days, Capecitabine 625 mg/m2 po bid days 2-21 (held for 48 hours prior to FDG-PET/CT in week 3) Bev 15 mg/kg d1 every 21 days (cycle 1 & cycle 2 only) Salvage chemotherapy for metabolic non-responders (DI + BEV): Docetaxel 30 mg/m2 d1, d8 every 21 days, CPT-11 50 mg/m2 d1, d8 every 21 days, Bev 15 mg/kg d1, cycle 2 only 2 cycles are planned prior to resection. Pts who aren't Cisplatin candidates (i.e. Creatinine clearance 40-60/cc, older age, marginal PS,etc.) may get oxaliplatin instead of cisplatin after discus with the PI. Oxaliplatin will be admin at 130 mg/m2 on day 1 every 21 days. Pts who aren't able to get Capecitabine (i.e. insurance restriction, unable to swallow, etc.) may get infusional fluorouracil instead of capecitabine after discus with the PI. Fluorouracil will be admin at 200 mg/m2/d x 21 days (held for 48 hours prior to FDGPET/ CT scan in week 3 of cycle 1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epirubicin, cisplatin, capecitabine, bevacizumab, docetaxel and irinotecan | Drug | Patients with FDG avid locally advanced but resectable gastric or GEJ adenocarcinoma will receive preoperative therapy with epirubicin, cisplatin, capecitabine (ECX), and bevacizumab. Each cycle of therapy is 21 days. Near the completion of cycle 1 of therapy (eg during week 3, target days 18-21), patients will undergo a second FDG-PET/CT scan. Note, patients will hold capecitabine for 48 hours prior to the FDG-PET/CT scan. Patients with a good metabolic response (eg. > 35% reduction in FDG uptake at the primary tumor on the week 3 PET scan as compared with baseline FDG uptake) will continue ECX for 2 additional cycles (cycle 2 and 3). Cycle 2 will be administered with bevacizumab and cycle 3 will be administered without bevacizumab. Patients will then proceed to surgery approximately 4-6 weeks following the completion of cycle 3. There is a 10-12 week time interval (eg. 70-84 days) between the last bevacizumab treatment and surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Will be Characterized by the Patient's FDG-PET Scan | A good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of > or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of < 35% on the week 3 PET scan compared with baseline. | 2 years |
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Inclusion Criteria:
Karnofsky performance status > or = to 70%.
The patient has adequate hematopoietic function, defined as having a total neutrophil count (ANC) ≥ or = to 1500/mm3, a platelet count ≥ or = 100,000/mm3. The patient has adequate renal and hepatic function, defined as having a serum creatinine ≤ or = to 2.5 mg/dl, urinalysis demonstrating < 2+ proteinuria and/or a urine protein/creatinine (UPC) ratio < 1.0. LFTs include a total serum bilirubin ≤ than or = to 2 x ULN, serum AST (SGOT)/ALT (SGPT) and ALK PHOS < than or = to 2.5 ULN.
The patient has a PT (INR) < than or = to 1.5 and an PTT < than or = to 3 seconds above the upper limits of normal (i.e. at MSKCC PTT < than or = to 37.7 sec) if the patient is not on anticoagulation.
If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment
Ability to understand informed consent and signing of written informed consent document prior to the initiation of treatment.
Exclusion Criteria:
Any metastatic disease.
Significant cardiac disease as defined as:
New York Heart Association (NYHA) grade II or greater (see Appendix B for NYHA Class),
congestive heart failure, or history of myocardial infarction or unstable angina within 12 months of study enrollment
Any history of stroke or transient ischemic attack at any time.
Pregnant (positive pregnancy test) or lactating women. A pregnancy test will be performed on sexually active women of childbearing potential prior to entry into the study. Treatment may not begin until the results of the pregnancy test are ascertained.
Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) on antihypertensive therapy.
Any prior history of hypertensive crisis or hypertensive encephalopathy.
Significant vascular disease (e.g. aortic aneurysm, aortic dissection)
Symptomatic peripheral vascular disease (ie. grade 2 or higher).
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting therapy (eg. day 0).
Core biopsy or other minor surgical procedure, excluding placement of a vascular device, within 7 days of starting therapy.
Evidence of bleeding diathesis or coagulopathy.
Proteinuria at screening as demonstrated by either
Serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
Serious, non-healing wound, ulcer, or bone fracture.
Grade 2 or greater pre-existing peripheral neuropathy.
Psychiatric disorders rendering patients incapable of complying with the requirements of the protocol.
Any concurrent active malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer or carcinoma-in-situ of the uterine cervix. Patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial.
Clinically significant hearing loss.
EKG evidence of acute ischemia or significant conduction abnormality, as determined by the treating physician.
Known hypersensitivity to Chinese hamster ovary cell products, other recominant human antibodies, or to any component of bevacizumab.
Patients with any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable 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 |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States | |||
| Memorial Sloan Kettering Cancer Center |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Commack |
| New York |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center | Rockville Centre | New York | United States |
| Memoral Sloan Kettering Cancer Center@Phelps | Sleepy Hollow | New York | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma |
| 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 |
|
| 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 | Overall Response Will be Characterized by the Patient's FDG-PET Scan | A good early FDG Response is a reduction in FDG uptake on the week 3 PET scan of > or = to 35% from baseline. An FDG PET non-responder will be defined as having a decrease of < 35% on the week 3 PET scan compared with baseline. | Posted | Number | participants | 2 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 | All Patients | ALL patients - Pre-operative Chemotherapy Plus Bevacizumab with Early Salvage Therapy in Patients with Locally Advanced but Resectable Gastric and GEJ Adenocarcinoma | 12 | 23 | 21 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Death not associated with CTCAE term- Death NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Fistula, GI- Stomach | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Infection with Grade 3/4 neutropenia, Lung (pneumonia) | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Leak, GI- Small Bowel | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Leak, GI- Stomach | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Mucositis (Clincal exam)- Oral cavity | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Abdomen NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTC-3.0 | Systematic Assessment |
| |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTC-3.0 | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Cardiac disorders | CTC-3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Weight loss | General disorders | CTC-3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| ALT, SGPT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Anorexia | General disorders | CTC-3.0 | Systematic Assessment |
| |
| AST, SGOT | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Fever (in the absence of neutropenia) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Glucose, low (hypoglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| prothrombin time international normalized ratio | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Magnesium, high (hypermagnesemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Mucositis - Larynx | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Neutrophils/granulocytes | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Pain - Abdomen NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Sodium, high (hypernatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTC-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 |
|---|---|
| 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 |
|---|---|
| D015251 | Epirubicin |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| D000077146 | Irinotecan |
| C074807 | BaseLine dental cement |
| D013995 | Time |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| 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 |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D055585 | Physical Phenomena |
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