{
"info": {
"nct_id": "NCT00017082",
"official_title": "A Multicenter, Phase II Study Of Oxaliplatin Single Agent As Third-Line Treatment Of Metastatic Colorectal Carcinoma",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum Not amenable to potentially curative treatment (e.g., inoperable metastatic disease) Must have received 2, and only 2, prior chemotherapy regimens for metastatic or recurrent disease, including the following: First-line therapy with bolus or continuous infusion fluorouracil (5-FU) (with or without leucovorin calcium) or capecitabine OR Adjuvant therapy with 5-FU and leucovorin calcium after relapse during or within 6 months of completion of first-line therapy Second-line therapy with irinotecan or after adjuvant 5-FU and leucovorin calcium treatment failure Progressive disease by CT scan or MRI during or after first-line treatment as above OR during or within 6 months of completion of adjuvant chemotherapy as above AND during second-line irinotecan or after adjuvant treatment failure as above At least 1 unidimensionally measurable lesion At least 20 mm by CT scan or MRI At least 10 mm by spiral CT scan\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (6 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No myocardial infarction within the past 6 months No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: No history of intolerance to antiemetics (e.g., 5-HT3 antagonists) or antidiarrheal medication (e.g., loperamide) to be administered concurrently with study chemotherapy No history of allergies to drugs containing platinum No known concurrent peripheral neuropathy No diabetes No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No other active cancer from another primary site except surgically treated non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer with an undetectable PSA level\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy, including irinotecan, for metastatic or recurrent disease and recovered No other prior first-line chemotherapy agents for metastatic or recurrent disease No prior adjuvant irinotecan No prior oxaliplatin Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to target lesions unless documented disease progression within the radiation portal Surgery: See Disease Characteristics More than 4 weeks since prior surgery for primary or metastatic disease and recovered Other: No prior investigational anticancer drug administered with irinotecan No other concurrent investigational drugs"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy, including irinotecan, for metastatic or recurrent disease and recovered No other prior first-line chemotherapy agents for metastatic or recurrent disease No prior adjuvant irinotecan No prior oxaliplatin Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy No prior radiotherapy to target lesions unless documented disease progression within the radiation portal Surgery: See Disease Characteristics More than 4 weeks since prior surgery for primary or metastatic disease and recovered Other: No prior investigational anticancer drug administered with irinotecan No other concurrent investigational drugs",
"criterions": [
{
"exact_snippets": "No prior biologic therapy",
"criterion": "prior biologic therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "At least 3 weeks since prior chemotherapy",
"criterion": "time since prior chemotherapy",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "No other prior first-line chemotherapy agents for metastatic or recurrent disease",
"criterion": "prior first-line chemotherapy agents for metastatic or recurrent disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No prior adjuvant irinotecan",
"criterion": "prior adjuvant irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No prior oxaliplatin",
"criterion": "prior oxaliplatin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "At least 3 weeks since prior radiotherapy",
"criterion": "time since prior radiotherapy",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "No prior radiotherapy to target lesions unless documented disease progression within the radiation portal",
"criterion": "prior radiotherapy to target lesions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "More than 4 weeks since prior surgery for primary or metastatic disease",
"criterion": "time since prior surgery for primary or metastatic disease",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 4,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "No prior investigational anticancer drug administered with irinotecan",
"criterion": "prior investigational anticancer drug administered with irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No other concurrent investigational drugs",
"criterion": "concurrent investigational drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "No prior biologic therapy",
"criterion": "prior biologic therapy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "At least 3 weeks since prior chemotherapy",
"criterion": "time since prior chemotherapy",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
}
]
}
}
},
{
"exact_snippets": "No other prior first-line chemotherapy agents for metastatic or recurrent disease",
"criterion": "prior first-line chemotherapy agents for metastatic or recurrent disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "No prior adjuvant irinotecan",
"criterion": "prior adjuvant irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "No prior oxaliplatin",
"criterion": "prior oxaliplatin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "At least 3 weeks since prior radiotherapy",
"criterion": "time since prior radiotherapy",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
}
]
}
}
}
]
},
{
"condition": {
"exact_snippets": "No prior radiotherapy to target lesions unless documented disease progression within the radiation portal",
"criterion": "prior radiotherapy to target lesions",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "documented disease progression within the radiation portal",
"criterion": "documented disease progression within the radiation portal",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
]
},
{
"exact_snippets": "More than 4 weeks since prior surgery for primary or metastatic disease",
"criterion": "time since prior surgery for primary or metastatic disease",
"requirement": {
"requirement_type": "time since",
"expected_value": {
"comparisons": [
{
"operator": ">",
"value": 4,
"unit": "weeks"
}
]
}
}
}
]
},
{
"exact_snippets": "No prior investigational anticancer drug administered with irinotecan",
"criterion": "prior investigational anticancer drug administered with irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "No other concurrent investigational drugs",
"criterion": "concurrent investigational drugs",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "See Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "See Disease Characteristics"
}
}
]
},
{
"exact_snippets": "See Disease Characteristics",
"criterion": "disease characteristics",
"requirement": {
"requirement_type": "N/A",
"expected_value": "See Disease Characteristics"
}
}
]
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum Not amenable to potentially curative treatment (e.g., inoperable metastatic disease) Must have received 2, and only 2, prior chemotherapy regimens for metastatic or recurrent disease, including the following: First-line therapy with bolus or continuous infusion fluorouracil (5-FU) (with or without leucovorin calcium) or capecitabine OR Adjuvant therapy with 5-FU and leucovorin calcium after relapse during or within 6 months of completion of first-line therapy Second-line therapy with irinotecan or after adjuvant 5-FU and leucovorin calcium treatment failure Progressive disease by CT scan or MRI during or after first-line treatment as above OR during or within 6 months of completion of adjuvant chemotherapy as above AND during second-line irinotecan or after adjuvant treatment failure as above At least 1 unidimensionally measurable lesion At least 20 mm by CT scan or MRI At least 10 mm by spiral CT scan",
"criterions": [
{
"exact_snippets": "Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum",
"criterion": "adenocarcinoma of the colon or rectum",
"requirement": {
"requirement_type": "confirmation",
"expected_value": "histologically or cytologically"
}
},
{
"exact_snippets": "Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum",
"criterion": "adenocarcinoma of the colon or rectum",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
},
{
"exact_snippets": "Histologically or cytologically confirmed recurrent metastatic adenocarcinoma of the colon or rectum",
"criterion": "adenocarcinoma of the colon or rectum",
"requirement": {
"requirement_type": "metastasis",
"expected_value": true
}
},
{
"exact_snippets": "Not amenable to potentially curative treatment (e.g., inoperable metastatic disease)",
"criterion": "curative treatment",
"requirement": {
"requirement_type": "amenability",
"expected_value": false
}
},
{
"exact_snippets": "Must have received 2, and only 2, prior chemotherapy regimens for metastatic or recurrent disease",
"criterion": "prior chemotherapy regimens",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "=",
"value": 2,
"unit": "regimens"
}
}
},
{
"exact_snippets": "First-line therapy with bolus or continuous infusion fluorouracil (5-FU) (with or without leucovorin calcium) or capecitabine",
"criterion": "first-line therapy",
"requirement": {
"requirement_type": "medication",
"expected_value": [
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]
}
},
{
"exact_snippets": "Adjuvant therapy with 5-FU and leucovorin calcium after relapse during or within 6 months of completion of first-line therapy",
"criterion": "adjuvant therapy",
"requirement": {
"requirement_type": "medication",
"expected_value": [
"5-FU",
"leucovorin calcium"
]
}
},
{
"exact_snippets": "Adjuvant therapy with 5-FU and leucovorin calcium after relapse during or within 6 months of completion of first-line therapy",
"criterion": "adjuvant therapy",
"requirement": {
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"expected_value": "after relapse during or within 6 months of completion of first-line therapy"
}
},
{
"exact_snippets": "Second-line therapy with irinotecan or after adjuvant 5-FU and leucovorin calcium treatment failure",
"criterion": "second-line therapy",
"requirement": {
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"expected_value": "irinotecan"
}
},
{
"exact_snippets": "Progressive disease by CT scan or MRI during or after first-line treatment as above OR during or within 6 months of completion of adjuvant chemotherapy as above AND during second-line irinotecan or after adjuvant treatment failure as above",
"criterion": "progressive disease",
"requirement": {
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"expected_value": "CT scan or MRI"
}
},
{
"exact_snippets": "Progressive disease by CT scan or MRI during or after first-line treatment as above OR during or within 6 months of completion of adjuvant chemotherapy as above AND during second-line irinotecan or after adjuvant treatment failure as above",
"criterion": "progressive disease",
"requirement": {
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"expected_value": "during or after first-line treatment OR during or within 6 months of completion of adjuvant chemotherapy AND during second-line irinotecan or after adjuvant treatment failure"
}
},
{
"exact_snippets": "At least 1 unidimensionally measurable lesion",
"criterion": "unidimensionally measurable lesion",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 1,
"unit": "lesion"
}
}
},
{
"exact_snippets": "At least 20 mm by CT scan or MRI",
"criterion": "lesion size by CT scan or MRI",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "mm"
}
}
},
{
"exact_snippets": "At least 10 mm by spiral CT scan",
"criterion": "lesion size by spiral CT scan",
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"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "mm"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN (6 times ULN if liver metastases present) Alkaline phosphatase no greater than 2 times ULN (6 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No myocardial infarction within the past 6 months No New York Heart Association class III or IV symptomatic congestive heart failure No serious cardiac arrhythmia Pulmonary: No interstitial pneumonia or extensive and symptomatic fibrosis of the lung Other: No history of intolerance to antiemetics (e.g., 5-HT3 antagonists) or antidiarrheal medication (e.g., loperamide) to be administered concurrently with study chemotherapy No history of allergies to drugs containing platinum No known concurrent peripheral neuropathy No diabetes No active infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No other active cancer from another primary site except surgically treated non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer with an undetectable PSA level",
"criterions": [
{
"exact_snippets": "Age: 18 and over",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
},
{
"exact_snippets": "Performance status: Karnofsky 50-100%",
"criterion": "performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 50,
"unit": "%"
},
{
"operator": "<=",
"value": 100,
"unit": "%"
}
]
}
}
},
{
"exact_snippets": "Life expectancy: Not specified",
"criterion": "life expectancy",
"requirement": {
"requirement_type": "specification",
"expected_value": "Not specified"
}
},
{
"exact_snippets": "Absolute neutrophil count at least 1,500/mm3",
"criterion": "absolute neutrophil count",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Platelet count at least 100,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Bilirubin no greater than 1.5 times upper limit of normal (ULN)",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "SGOT and SGPT no greater than 2 times ULN (6 times ULN if liver metastases present)",
"criterion": "SGOT and SGPT levels",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "SGOT and SGPT no greater than 2 times ULN (6 times ULN if liver metastases present)",
"criterion": "SGOT and SGPT levels",
"requirement": {
"requirement_type": "maximum with condition",
"expected_value": "6 times ULN if liver metastases present"
}
},
{
"exact_snippets": "Alkaline phosphatase no greater than 2 times ULN (6 times ULN if liver metastases present)",
"criterion": "alkaline phosphatase level",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "Alkaline phosphatase no greater than 2 times ULN (6 times ULN if liver metastases present)",
"criterion": "alkaline phosphatase level",
"requirement": {
"requirement_type": "maximum with condition",
"expected_value": "6 times ULN if liver metastases present"
}
},
{
"exact_snippets": "Creatinine no greater than 1.5 times ULN",
"criterion": "creatinine level",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "times ULN"
}
}
},
{
"exact_snippets": "No unstable angina",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No myocardial infarction within the past 6 months",
"criterion": "myocardial infarction",
"requirement": {
"requirement_type": "recency",
"expected_value": "not within the past 6 months"
}
},
{
"exact_snippets": "No New York Heart Association class III or IV symptomatic congestive heart failure",
"criterion": "New York Heart Association class III or IV symptomatic congestive heart failure",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No serious cardiac arrhythmia",
"criterion": "serious cardiac arrhythmia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No interstitial pneumonia or extensive and symptomatic fibrosis of the lung",
"criterion": "interstitial pneumonia or extensive and symptomatic fibrosis of the lung",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No history of intolerance to antiemetics (e.g., 5-HT3 antagonists) or antidiarrheal medication (e.g., loperamide) to be administered concurrently with study chemotherapy",
"criterion": "intolerance to antiemetics or antidiarrheal medication",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "No history of allergies to drugs containing platinum",
"criterion": "allergies to drugs containing platinum",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "No known concurrent peripheral neuropathy",
"criterion": "concurrent peripheral neuropathy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No diabetes",
"criterion": "diabetes",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No active infection",
"criterion": "active infection",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Not pregnant or nursing",
"criterion": "pregnancy or nursing",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
},
{
"exact_snippets": "Negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
},
{
"exact_snippets": "Fertile patients must use effective contraception during and for 6 months after study",
"criterion": "contraception use",
"requirement": {
"requirement_type": "requirement for fertile patients",
"expected_value": "use effective contraception during and for 6 months after study"
}
},
{
"exact_snippets": "No other active cancer from another primary site except surgically treated non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer with an undetectable PSA level",
"criterion": "other active cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No other active cancer from another primary site except surgically treated non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer with an undetectable PSA level",
"criterion": "other active cancer",
"requirement": {
"requirement_type": "exceptions",
"expected_value": [
"surgically treated non-melanoma skin cancer",
"carcinoma in situ of the cervix",
"localized prostate cancer with an undetectable PSA level"
]
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
]
}