{
"info": {
"nct_id": "NCT00911820",
"official_title": "A Randomized, Multicenter, Phase II Trial of Cisplatin, Irinotecan and Bevacizumab (PCA) vs. Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer",
"inclusion_criteria": "* Histologically confirmed, unresectable esophageal, GE junction or gastric adenocarcinoma (including adenosquamous, or undifferentiated carcinoma). Measurable disease is not required.\n* 18 years of age or older\n* ECOG Performance Status=2\n* Life expectancy of 12 weeks or greater\n* Adequate bone marrow, renal and liver function as outlined in the protocol.\n* Men and women of childbearing potential must use adequate contraception\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Prior chemotherapy (except as part of pre- or post-operative therapy, completed at least 1 prior to start of this protocol).\n* Squamous cell carcinoma histology of esophageal, GE junction or gastric tumor\n* Known history of allergy or hypersensitivity to Chinese hamster ovary products, polysorbate 80, or any of the study drugs\n* Treatment or planned participation in an experimental drug study within 4 weeks of C1 D1. Concurrent use of herbal medications or other alternative therapies\n* Major surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies, within 7 days of cycle 1 day 1\n* Palliative radiation to 25% or less of bone marrow, must be completed > 2 weeks prior to day 1, palliative radiation to > 25% of bone marrow, must be completed > 4 weeks prior to day 1\n* Myocardial infarction, unstable angina, CVA or TIA or other thrombotic event in the past six months\n* Inadequately controlled hypertension (defined as systolic blood pressure of >150mmHg and/or diastolic blood pressure of > 100mmHg). Initiation of antihypertensive medication is recommended, however adequate control of blood pressure must be documented prior to C1 D1\n* No history of prior hypertensive crisis or hypertensive encephalopathy\n* NYHA Grade II or greater congestive heart failure\n* Clinically significant peripheral vascular disease\n* Active bleeding from primary tumor\n* Evidence of bleeding diatheses or coagulopathy (other than deep venous thrombosis, portal vein thrombosis, pulmonary embolism, or atrial fibrillation). Patients on therapeutic anticoagulation may be enrolled provided they have been clinically stable on anticoagulation for a least 2 weeks prior to C1 D1.\n* Uncontrolled serious medical or psychiatric illness\n* Uncontrolled diarrhea\n* Peripheral neuropathy\n* No known brain or other CNS metastasis by history or clinical examination\n* Other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected or previously treated cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years\n* Urine protein:creatinine ratio 1.0 or greater at screening\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess with 6 months of C1 D1\n* Serious, non-healing wound, ulcer or bone fracture\n* Pregnant or breast feeding\n* Inability to comply with study and/or follow-up procedures\n* History of HIV seropositivity, hepatitis C virus, acute or chronic hepatitis B, or other serious chronic infection",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Histologically confirmed, unresectable esophageal, GE junction or gastric adenocarcinoma (including adenosquamous, or undifferentiated carcinoma). Measurable disease is not required.",
"criterions": [
{
"exact_snippets": "Histologically confirmed, unresectable esophageal, GE junction or gastric adenocarcinoma (including adenosquamous, or undifferentiated carcinoma)",
"criterion": "esophageal, GE junction or gastric adenocarcinoma",
"requirements": [
{
"requirement_type": "confirmation",
"expected_value": "histologically confirmed"
},
{
"requirement_type": "resectability",
"expected_value": "unresectable"
},
{
"requirement_type": "subtypes",
"expected_value": [
"adenosquamous",
"undifferentiated carcinoma"
]
}
]
},
{
"exact_snippets": "Measurable disease is not required",
"criterion": "measurable disease",
"requirements": [
{
"requirement_type": "requirement",
"expected_value": false
}
]
}
]
},
{
"line": "* 18 years of age or older",
"criterions": [
{
"exact_snippets": "18 years of age or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* ECOG Performance Status=2",
"criterions": [
{
"exact_snippets": "ECOG Performance Status=2",
"criterion": "ECOG Performance Status",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "=",
"value": 2,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Life expectancy of 12 weeks or greater",
"criterions": [
{
"exact_snippets": "Life expectancy of 12 weeks or greater",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "* Adequate bone marrow, renal and liver function as outlined in the protocol.",
"criterions": [
{
"exact_snippets": "Adequate bone marrow",
"criterion": "bone marrow function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": "as outlined in the protocol"
}
]
},
{
"exact_snippets": "Adequate ... renal ... function",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": "as outlined in the protocol"
}
]
},
{
"exact_snippets": "Adequate ... liver function",
"criterion": "liver function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": "as outlined in the protocol"
}
]
}
]
},
{
"line": "* Men and women of childbearing potential must use adequate contraception",
"criterions": [
{
"exact_snippets": "Men and women of childbearing potential",
"criterion": "childbearing potential",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "must use adequate contraception",
"criterion": "contraception use",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Prior chemotherapy (except as part of pre- or post-operative therapy, completed at least 1 prior to start of this protocol).",
"criterions": [
{
"exact_snippets": "Prior chemotherapy (except as part of pre- or post-operative therapy, completed at least 1 prior to start of this protocol)",
"criterion": "prior chemotherapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
},
{
"requirement_type": "timing",
"expected_value": "completed at least 1 prior to start of this protocol"
},
{
"requirement_type": "exclusion",
"expected_value": "except as part of pre- or post-operative therapy"
}
]
}
]
},
{
"line": "* Squamous cell carcinoma histology of esophageal, GE junction or gastric tumor",
"criterions": [
{
"exact_snippets": "Squamous cell carcinoma histology",
"criterion": "histology",
"requirements": [
{
"requirement_type": "type",
"expected_value": "squamous cell carcinoma"
}
]
},
{
"exact_snippets": "esophageal, GE junction or gastric tumor",
"criterion": "tumor location",
"requirements": [
{
"requirement_type": "location",
"expected_value": [
"esophageal",
"GE junction",
"gastric"
]
}
]
}
]
},
{
"line": "* Known history of allergy or hypersensitivity to Chinese hamster ovary products, polysorbate 80, or any of the study drugs",
"criterions": [
{
"exact_snippets": "Known history of allergy or hypersensitivity to Chinese hamster ovary products",
"criterion": "allergy or hypersensitivity to Chinese hamster ovary products",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Known history of allergy or hypersensitivity to ... polysorbate 80",
"criterion": "allergy or hypersensitivity to polysorbate 80",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Known history of allergy or hypersensitivity to ... any of the study drugs",
"criterion": "allergy or hypersensitivity to any of the study drugs",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Treatment or planned participation in an experimental drug study within 4 weeks of C1 D1. Concurrent use of herbal medications or other alternative therapies",
"criterions": [
{
"exact_snippets": "Treatment or planned participation in an experimental drug study within 4 weeks of C1 D1",
"criterion": "participation in an experimental drug study",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 4,
"unit": "weeks"
}
]
}
}
]
},
{
"exact_snippets": "Concurrent use of herbal medications or other alternative therapies",
"criterion": "use of herbal medications or other alternative therapies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Major surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies, within 7 days of cycle 1 day 1",
"criterions": [
{
"exact_snippets": "Major surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies, within 7 days of cycle 1 day 1",
"criterion": "major surgical procedures",
"requirements": [
{
"requirement_type": "time since procedure",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
]
}
]
},
{
"line": "* Palliative radiation to 25% or less of bone marrow, must be completed > 2 weeks prior to day 1, palliative radiation to > 25% of bone marrow, must be completed > 4 weeks prior to day 1",
"criterions": [
{
"exact_snippets": "Palliative radiation to 25% or less of bone marrow, must be completed > 2 weeks prior to day 1",
"criterion": "palliative radiation to 25% or less of bone marrow",
"requirements": [
{
"requirement_type": "completion time",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "palliative radiation to > 25% of bone marrow, must be completed > 4 weeks prior to day 1",
"criterion": "palliative radiation to > 25% of bone marrow",
"requirements": [
{
"requirement_type": "completion time",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "* Myocardial infarction, unstable angina, CVA or TIA or other thrombotic event in the past six months",
"criterions": [
{
"exact_snippets": "Myocardial infarction ... in the past six months",
"criterion": "myocardial infarction",
"requirements": [
{
"requirement_type": "occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "unstable angina ... in the past six months",
"criterion": "unstable angina",
"requirements": [
{
"requirement_type": "occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "CVA ... in the past six months",
"criterion": "CVA",
"requirements": [
{
"requirement_type": "occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "TIA ... in the past six months",
"criterion": "TIA",
"requirements": [
{
"requirement_type": "occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
},
{
"exact_snippets": "other thrombotic event in the past six months",
"criterion": "other thrombotic event",
"requirements": [
{
"requirement_type": "occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
}
]
},
{
"line": "* Inadequately controlled hypertension (defined as systolic blood pressure of >150mmHg and/or diastolic blood pressure of > 100mmHg). Initiation of antihypertensive medication is recommended, however adequate control of blood pressure must be documented prior to C1 D1",
"criterions": [
{
"exact_snippets": "Inadequately controlled hypertension (defined as systolic blood pressure of >150mmHg",
"criterion": "systolic blood pressure",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 150,
"unit": "mmHg"
}
}
]
},
{
"exact_snippets": "Inadequately controlled hypertension ... diastolic blood pressure of > 100mmHg",
"criterion": "diastolic blood pressure",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">",
"value": 100,
"unit": "mmHg"
}
}
]
}
]
},
{
"line": "* No history of prior hypertensive crisis or hypertensive encephalopathy",
"criterions": [
{
"exact_snippets": "No history of prior hypertensive crisis",
"criterion": "hypertensive crisis",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
},
{
"exact_snippets": "No history of prior ... hypertensive encephalopathy",
"criterion": "hypertensive encephalopathy",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
}
]
},
{
"line": "* NYHA Grade II or greater congestive heart failure",
"criterions": [
{
"exact_snippets": "NYHA Grade II or greater congestive heart failure",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "NYHA Grade"
}
}
]
}
]
},
{
"line": "* Clinically significant peripheral vascular disease",
"criterions": [
{
"exact_snippets": "Clinically significant peripheral vascular disease",
"criterion": "peripheral vascular disease",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "clinically significant"
}
]
}
]
},
{
"line": "* Active bleeding from primary tumor",
"criterions": [
{
"exact_snippets": "Active bleeding from primary tumor",
"criterion": "active bleeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Active bleeding from primary tumor",
"criterion": "primary tumor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Evidence of bleeding diatheses or coagulopathy (other than deep venous thrombosis, portal vein thrombosis, pulmonary embolism, or atrial fibrillation). Patients on therapeutic anticoagulation may be enrolled provided they have been clinically stable on anticoagulation for a least 2 weeks prior to C1 D1.",
"criterions": [
{
"exact_snippets": "Evidence of bleeding diatheses",
"criterion": "bleeding diatheses",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Evidence of ... coagulopathy",
"criterion": "coagulopathy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Patients on therapeutic anticoagulation ... clinically stable on anticoagulation for a least 2 weeks",
"criterion": "therapeutic anticoagulation",
"requirements": [
{
"requirement_type": "stability duration",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "* Uncontrolled serious medical or psychiatric illness",
"criterions": [
{
"exact_snippets": "Uncontrolled serious medical ... illness",
"criterion": "serious medical illness",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
]
},
{
"exact_snippets": "Uncontrolled ... psychiatric illness",
"criterion": "psychiatric illness",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
}
]
}
]
},
{
"line": "* Uncontrolled diarrhea",
"criterions": [
{
"exact_snippets": "Uncontrolled diarrhea",
"criterion": "diarrhea",
"requirements": [
{
"requirement_type": "control",
"expected_value": false
}
]
}
]
},
{
"line": "* Peripheral neuropathy",
"criterions": [
{
"exact_snippets": "Peripheral neuropathy",
"criterion": "peripheral neuropathy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* No known brain or other CNS metastasis by history or clinical examination",
"criterions": [
{
"exact_snippets": "No known brain ... metastasis by history or clinical examination",
"criterion": "brain metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "No known ... other CNS metastasis by history or clinical examination",
"criterion": "CNS metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected or previously treated cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years",
"criterions": [
{
"exact_snippets": "Other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma.",
"criterion": "active malignancy",
"requirements": [
{
"requirement_type": "exclusion",
"expected_value": [
"non-melanoma skin cancer",
"in-situ cervical carcinoma"
]
}
]
},
{
"exact_snippets": "A resected or previously treated cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years",
"criterion": "resected or previously treated cancer",
"requirements": [
{
"requirement_type": "recurrence",
"expected_value": {
"operator": "=",
"value": 0,
"unit": "evidence of recurrence"
}
},
{
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Urine protein:creatinine ratio 1.0 or greater at screening",
"criterions": [
{
"exact_snippets": "Urine protein:creatinine ratio 1.0 or greater at screening",
"criterion": "urine protein:creatinine ratio",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 1.0,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "* Serious, non-healing wound, ulcer or bone fracture",
"criterions": [
{
"exact_snippets": "Serious, non-healing wound",
"criterion": "wound",
"requirements": [
{
"requirement_type": "healing status",
"expected_value": "non-healing"
},
{
"requirement_type": "severity",
"expected_value": "serious"
}
]
},
{
"exact_snippets": "Serious, non-healing ... ulcer",
"criterion": "ulcer",
"requirements": [
{
"requirement_type": "healing status",
"expected_value": "non-healing"
},
{
"requirement_type": "severity",
"expected_value": "serious"
}
]
},
{
"exact_snippets": "Serious, non-healing ... bone fracture",
"criterion": "bone fracture",
"requirements": [
{
"requirement_type": "healing status",
"expected_value": "non-healing"
},
{
"requirement_type": "severity",
"expected_value": "serious"
}
]
}
]
},
{
"line": "* Pregnant or breast feeding",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "breast feeding",
"criterion": "breastfeeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Inability to comply with study and/or follow-up procedures",
"criterions": [
{
"exact_snippets": "Inability to comply with study and/or follow-up procedures",
"criterion": "compliance with study procedures",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "Inability to comply with study and/or follow-up procedures",
"criterion": "compliance with follow-up procedures",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* History of HIV seropositivity, hepatitis C virus, acute or chronic hepatitis B, or other serious chronic infection",
"criterions": [
{
"exact_snippets": "History of HIV seropositivity",
"criterion": "HIV seropositivity",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "hepatitis C virus",
"criterion": "hepatitis C virus",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "acute or chronic hepatitis B",
"criterion": "hepatitis B",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"acute",
"chronic"
]
}
]
},
{
"exact_snippets": "other serious chronic infection",
"criterion": "serious chronic infection",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess with 6 months of C1 D1",
"criterions": [
{
"exact_snippets": "History of abdominal fistula",
"criterion": "abdominal fistula",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "History of ... gastrointestinal perforation",
"criterion": "gastrointestinal perforation",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "History of ... intra-abdominal abscess",
"criterion": "intra-abdominal abscess",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "within 6 months of C1 D1",
"criterion": "time since event",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
]
}
]
}
],
"failed_miscellaneous": []
}