| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00291 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| UCCRC-16402A | |||
| CDR0000617085 | |||
| 8199 | Other Identifier | University of Chicago Comprehensive Cancer Center | |
| 8199 | Other Identifier | CTEP | |
| N01CM62201 | U.S. NIH Grant/Contract | View source | |
| N01CM62205 | U.S. NIH Grant/Contract | View source | |
| N01CM62204 | U.S. NIH Grant/Contract | View source | |
| N01CM00100 | U.S. NIH Grant/Contract | View source | |
| N01CM00038 | U.S. NIH Grant/Contract | View source | |
| N01CM00099 | U.S. NIH Grant/Contract | View source | |
| N01CM62207 | U.S. NIH Grant/Contract | View source |
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The trial was permanently halted due to futility concerns.
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This randomized phase II trial is studying mitotane and IMC-A12 to see how well they work compared with mitotane alone in treating patients with recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as mitotane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as IMC-A12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether mitotane is more effective with or without monoclonal antibody IMC-A12 in treating adrenocortical cancer.
PRIMARY OBJECTIVES:
I. Compare the progression-free survival (PFS) rate in patients with recurrent, metastatic, or primary unresectable adrenocortical carcinoma treated with mitotane with vs without anti-IGF-1R recombinant monoclonal antibody IMC-A12 (IMC-A12).
SECONDARY OBJECTIVES:
I. Compare the response rates in these patients using Response Evaluation Criteria in Solid Tumor (RECIST) criteria.
II. Compare the change in tumor size from baseline to 12 weeks in these patients.
III. Compare the overall trajectories in tumor growth in these patients.
TERTIARY OBJECTIVES:
I. Define predictive markers of response or insensitivity to IMC-A12. II. Define pharmacodynamic markers of IMC-A12. III. Determine whether tumor expression of IGF-IR and activation of downstream signaling in archival tumor tissue samples predict efficacy of IMC-A12.
OUTLINE: This is a multicenter study that includes a single-arm safety evaluation phase followed by a randomized phase. Initially, patients are enrolled in the safety evaluation phase. If ≤ 6 of 20 patients experience a dose-limiting toxicity, then the study may proceed to the randomized phase.
SAFETY EVALUATION PHASE: Patients receive oral mitotane once or twice daily and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
RANDOMIZED PHASE: Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral mitotane once or twice daily in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may cross over and receive treatment on arm II.
ARM II: Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity.
Archival frozen tissue blocks, unstained tumor tissue slides from archival paraffin blocks, plasma samples, and urine samples may be collected and stored for future correlative biomarker studies.
After completion of study therapy, patients are followed up for 6 months.
NOTE: The study was terminated after the safety evaluation phase (i.e., before the randomization phase) due to futility concerns. Thus, patients were only enrolled into ARM II (i.e., mitotate + IMC-A12). Results presented in this report are only given for the safety evaluation phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm II (Mitotane + IMC-A12) | Experimental | Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-A12 | Biological | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Rate at 6 Weeks | Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 6 weeks |
| Progression-free Survival Rate at 12 Weeks | Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 12 weeks |
| Progression-free Survival Rate at 18 Weeks | Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Best Response Rates | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. |
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Inclusion Criteria:
Histologically confirmed adrenocortical carcinoma
At least 1 lesion that can be accurately measured by RECIST criteria as ≥ 20 mm by conventional radiologic techniques or as ≥ 10 mm by spiral CT scan or MRI
No tumors potentially resectable by surgical excision alone
No known or suspected leptomeningeal disease or brain metastases
ECOG performance status 0-2
Life expectancy ≥ 12 weeks
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9 g/dL (transfusion allowed)
Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 60 mL/min
AST or ALT ≤ 3 times ULN
Total bilirubin ≤ 1.5 times ULN
HbA1c < 8 within the past 4 weeks
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 3 months after completion of study therapy
Able to take oral medications
No poor gastrointestinal absorption
Patients with diabetes mellitus are eligible provided they meet all of the following criteria:
No active uncontrolled infection
No severe disease or condition that, in the judgement of the investigator, would make the patient inappropriate for study participation, including, but not limited to:
No current malignancy or previous malignancy with a disease-free interval of < 2 years at the time of diagnosis
No known hypersensitivity to monoclonal antibody therapy or mitotane
No known HIV or hepatitis B or C infection
No serious medical or psychiatric disorder that would interfere with patient safety or informed consent
All significant toxic effects of prior surgery resolved to ≤ grade 1 according to NCI CTCAE v. 3.0 criteria
Mitotane for < 8 weeks prior to study entry AND tolerated it well
No prior IGFR-directed therapy
No prior systemic antitumor therapy (cytotoxic chemotherapy, biologic, immunotherapy, or targeted therapy)
No prior radiotherapy to > 20% of bone marrow
More than 4 weeks since prior and no concurrent radiotherapy
No concurrent mitotane ≥ 8 weeks prior to study
No concurrent tumor resection or tumor-directed surgery
No other concurrent anticancer or investigational therapy
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| Name | Affiliation | Role |
|---|---|---|
| Gary Hammer | University of Chicago Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033-0804 | United States | ||
| University of Chicago Comprehensive Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy and Monoclonal Antibody Therapy | Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| mitotane | Drug | Given orally |
|
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| Up to 6 months |
| Response at 6 Weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. | 6 weeks |
| Response at 12 Weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. | 12 weeks |
| Response at 18 Weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. | 18 weeks |
| Response at 48 Weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. | 48 weeks |
| Number of Patients Exhibiting Decrease in Tumor Size at 6 Weeks | Total number of patients whose tumor size at 6 weeks was smaller than their tumor size recorded at baseline (by any amount). | 6 weeks |
| Number of Patients Exhibiting Decrease in Tumor Size at 12 Weeks | Total number of patients whose tumor size at 12 weeks was smaller than their tumor size recorded at baseline (by any amount). | 12 weeks |
| Number of Patients Exhibiting Decrease in Tumor Size at 18 Weeks | Total number of patients whose tumor size at 18 weeks was smaller than their tumor size recorded at baseline (by any amount). | 18 weeks |
| Number of Patients Exhibiting Decrease in Tumor Size at 48 Weeks | Total number of patients whose tumor size at 48 weeks was smaller than their tumor size recorded at baseline (by any amount). | 48 weeks |
| Chicago |
| Illinois |
| 60637-1470 |
| United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Central Illinois Hematology Oncology Center | Springfield | Illinois | 60702 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781-0001 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy and Monoclonal Antibody Therapy | Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Progression-free Survival Rate at 6 Weeks | Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | Posted | Number | percentage of participants | 6 weeks |
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| Primary | Progression-free Survival Rate at 12 Weeks | Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | Posted | Number | percentage of participants | 12 weeks |
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| Primary | Progression-free Survival Rate at 18 Weeks | Progression-free survival rates were estimated at 6, 12, and 18 weeks by the Kaplan-Meier method. At a given time point, this outcome is defined as the proportion of subjects who had not progressed or died. Disease progression is defined according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progression is characterized by a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | Posted | Number | percentage of participants | 18 weeks |
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| Secondary | Best Response Rates | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. | Posted | Number | percentage of participants | Up to 6 months |
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| Secondary | Response at 6 Weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. | Posted | Number | percentage of participants | 6 weeks |
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| Secondary | Response at 12 Weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. | Posted | Number | percentage of participants | 12 weeks |
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| Secondary | Response at 18 Weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. | Posted | Number | percentage of participants | 18 weeks |
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| Secondary | Response at 48 Weeks | RECIST v1.0 was used to evaluate patient response at each time point. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Subjects who were unevaluable for response were classified as having 'Unknown response'. Each patient's 'best response' was the most favorable of all recorded responses across all time points. Proportions of patients with each response as their best response are reported in this outcome. | Posted | Number | percentage of participants | 48 weeks |
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| Secondary | Number of Patients Exhibiting Decrease in Tumor Size at 6 Weeks | Total number of patients whose tumor size at 6 weeks was smaller than their tumor size recorded at baseline (by any amount). | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | Posted | Number | participants | 6 weeks |
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| Secondary | Number of Patients Exhibiting Decrease in Tumor Size at 12 Weeks | Total number of patients whose tumor size at 12 weeks was smaller than their tumor size recorded at baseline (by any amount). | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | Posted | Number | participants | 12 weeks |
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| Secondary | Number of Patients Exhibiting Decrease in Tumor Size at 18 Weeks | Total number of patients whose tumor size at 18 weeks was smaller than their tumor size recorded at baseline (by any amount). | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | Posted | Number | participants | 18 weeks |
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| Secondary | Number of Patients Exhibiting Decrease in Tumor Size at 48 Weeks | Total number of patients whose tumor size at 48 weeks was smaller than their tumor size recorded at baseline (by any amount). | The analysis population excludes two patients who withdrew from the study before the 6 week assessment. | Posted | Number | participants | 48 weeks |
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6 months
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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 | Chemotherapy and Monoclonal Antibody Therapy | Patients receive mitotane as in arm I and anti-IGF-1R recombinant monoclonal antibody IMC-A12 IV over 1 hour once every 2 weeks in the absence of disease progression or unacceptable toxicity. | 9 | 20 | 4 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Cholesterol high | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypertriglyceridemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Multi-organ failure | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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After the treatment of 20 subjects, a protocol defined interim analysis was completed for safety and futility. The trial was permanently halted based on futility concerns.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Walter M. Stadler, MD | The University of Chicago | (773) 702-6149 | wstadler@medicine.bsd.uchicago.edu |
| ID | Term |
|---|---|
| D018268 | Adrenocortical Carcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000306 | Adrenal Cortex Neoplasms |
| D000310 | Adrenal Gland Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D000303 | Adrenal Cortex Diseases |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C557414 | cixutumumab |
| D008939 | Mitotane |
| D003632 | Dichlorodiphenyldichloroethane |
| ID | Term |
|---|---|
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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