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Terminated due to poor enrollment and grade 3 toxicities noted during an interim analysis.
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| OSI Pharmaceuticals | INDUSTRY |
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The purpose of this study is to see if alternating chemotherapy with erlotinib increases tumor shrinkage in people with metastatic colorectal cancer. The investigator will also be studying the side effects (good and bad) of alternating chemotherapy with erlotinib on metastatic colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOLFOX with Erlotinib | Experimental | Subjects received FOLFOX (Leucovorin, Fluorouracil, and Oxaliplatin) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFOX on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22. |
|
| FOLFIRI with Erlotinib | Experimental | Subjects received FOLFIRI (Leucovorin, Fluorouracil, and Irinotecan) and Erlotinib. Treatment consisted of a 28 day cycle. Subjects received FOLFIRI on days 1, 2, and 3, and 15-16, followed by Erlotinib on days 3-8, and 17-22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib | Drug | Erlotinib oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. In addition to the active ingredient, erlotinib contains lactose (hydrous), microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, and magnesium stearate. Tablets containing 25 mg, 100 mg, and 150 mg of erlotinib are available. Each bottle will contain 30 tablets, a quantity sufficient for 4 consecutive weeks of dosing, with overage. |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rates of Radiographically Measurable Disease | The primary outcome measure will be the response rates of radiographically measurable disease. Response rate of disease will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. | Disease response assessed after every 2 Treatment Cycles, or around 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Second-line Progression Free Survival | Time to disease progression from start of second-line experimental regimen. Disease progression will be measured per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. |
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Inclusion Criteria:
Patients must fulfill all of the following criteria to be eligible for study entry:
Exclusion Criteria:
Patients meeting any of the following criteria are ineligible for study entry:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
Patients were stratified according to whether they had received 5-Fluorouracil/Leucovorin with Oxaliplatin or Fluorouracil, Leucovorin, and Irinotecan for their 1st line treatment. Whichever they had not received in the 1st line setting, they received on trial. 16 patients signed consent. 2 patients withdrew, 3 ineligible, and 1 unevaluable.
Enrollment was done from 3/28/2008 to the study closure of 12/19/2011. Patients were recruited from the Oregon Health and Science University medical clinic as well as via referral from associated regional medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | FOLFIRI With Erlotinib | |
| FG001 | FOLFOX With Erlotinib |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
11 patients included for all baseline measures except for age, categorical because the age is missing for the 1 patient who eventually was ineligible.
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| ID | Title | Description |
|---|---|---|
| BG000 | FOLFIRI With Erlotinib | |
| BG001 | FOLFOX With Erlotinib | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number |
| 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 | Response Rates of Radiographically Measurable Disease | The primary outcome measure will be the response rates of radiographically measurable disease. Response rate of disease will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. | Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator. | Number | Number of Patients | Disease response assessed after every 2 Treatment Cycles, or around 8 weeks. |
|
Adverse Events have been collected since the study opened to enrollment to study closure, totaling 5.5 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 | FOLFIRI With Erlotinib |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Patient admitted with GI hemorrhage and malignant ascites, attributed to his underlying disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 Neutropenia while on trial. |
Study terminated before target enrollment was reached due to excessive toxicities and limited enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Lopez, MD | OHSU Knight Cancer Institute | 503-494-8534 | lopezc@ohsu.edu |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Fluorouracil | Drug | Antimetabolite used as a chemotherapy. Administered intravenously as a bolus injection at 400mg/m2 on Day 1 followed by 2400 mg/m2 continuously over 46 hours. |
|
| Leucovorin | Drug | Chemotherapy agent given as a supplement to Fluorouracil. Given intravenously 400mg/m2 in combination with Fluorouracil dosing. |
|
| Oxaliplatin | Drug | Platinum-based antineoplastic chemotherapy agent given intravenously at 85 mg/m2. |
|
| Irinotecan | Drug | Chemotherapy agent given intravenously at 180 mg/m2. |
|
| Upon completion of follow-up, for an average of 99 days following the initiation of study treatment. |
| Time to Second Progression (From Start of First-Line Regimen) | Number of days from the initiation of first line treatment to first documented progression. Progression will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progression free survival (time to progression or death, whichever occurs first) is the same as time to progression as all of the patients in this trial progressed. | Documented by Follow-up CT scans following first line treatment, average of 225 days. |
Total of all reporting groups
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | FOLFOX With Erlotinib |
|
|
| Secondary | Second-line Progression Free Survival | Time to disease progression from start of second-line experimental regimen. Disease progression will be measured per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. | Patients who were considered for analysis were those who received treatment in a manner consistent with the protocol, as determined by the investigator. 95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient. | Median | 95% Confidence Interval | Days | Upon completion of follow-up, for an average of 99 days following the initiation of study treatment. |
|
|
|
| Secondary | Time to Second Progression (From Start of First-Line Regimen) | Number of days from the initiation of first line treatment to first documented progression. Progression will be assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progression free survival (time to progression or death, whichever occurs first) is the same as time to progression as all of the patients in this trial progressed. | 95% CI cannot be computed for FOLFOX with Erlotinib arm because there is only one patient. | Median | 95% Confidence Interval | Days | Documented by Follow-up CT scans following first line treatment, average of 225 days. |
|
|
|
| 2 |
| 9 |
| 8 |
| 9 |
| EG001 | FOLFOX With Erlotinib | 0 | 1 | 1 | 1 |
|
| Malignant Ascites | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | Patient admitted with GI hemorrhage and malignant ascites, attributed to his underlying disease. |
|
| Weakness | General disorders | CTCAE (3.0) | Systematic Assessment | Patient admitted for weakness, fatigue, leukopenia, hyperbilirubinemia, and thrombocytopenia. All related to Fluorouracil, Leucovorin, and Irinotecan , and possibly related to Erlotinib, per the Investigator. |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | Patient admitted for weakness, fatigue, leukopenia, hyperbilirubinemia, and thrombocytopenia. All related to Fluorouracil, Leucovorin, and Irinotecan , and possibly related to Erlotinib, per the Investigator. |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Patient admitted for weakness, fatigue, leukopenia, hyperbilirubinemia, and thrombocytopenia. All related to Fluorouracil, Leucovorin, and Irinotecan, and possibly related to Erlotinib, per the Investigator. |
|
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Systematic Assessment | Patient admitted for weakness, fatigue, leukopenia, hyperbilirubinemia, and thrombocytopenia. All related to Fluorouracil, Leucovorin, and Irinotecan, and possibly related to Erlotinib, per the Investigator. |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Patient admitted for weakness, fatigue, leukopenia, hyperbilirubinemia, and thrombocytopenia. All related to Fluorouracil, Leucovorin, and Irinotecan, and possibly related to Erlotinib, per the Investigator. |
|
|
| Oral Pain | General disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 Oral Pain |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 Diarrhea |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 Nausea |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 Rash |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 Hyponatremia |
|
| International Normalized Ratio Elevation | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 |
|
| Abdominal Pain | General disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 Abdominal Pain |
|
| GI Bleed | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 GI Bleed |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 Fatigue |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 or 4 Leukopenia |
|
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| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |