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| ID | Type | Description | Link |
|---|---|---|---|
| HUM 00000749 | Other Identifier | University of Michigan IRBMED |
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The study was discontinued due to the death of a co-investigator and a second co-investigator leaving the institution.
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Colorectal cancer (CRC) is one of the more common cancers in the United States with over 145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some who relapse after surgery, or are unable to have surgery, chemotherapy is the primary treatment for this more advanced CRC. Some chemotherapy drugs are given to the patient by themselves, but many are given in combination with other chemotherapy treatment drugs and they seem to work better together than by themselves. This study will investigate the effectiveness of the combination of three chemotherapy drugs in patients who have been previously treated for their CRC and it has returned. This study will also evaluate any rash that is associated with the drug Cetuximab. The three therapy drugs are Mitomycin C, Irinotecan, and Cetuximab.
We propose a phase II trial which combines mitomycin C, irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer with wild type non mutated K-Ras. The goals of this investigation are to develop an effective systemic therapy for previously treated patients with CRC with wild type K-Ras, to further explore the relationship of mitomycin C induced topoisomerase 1 gene expression and response to irinotecan, and to define and characterize the biology of cetuximab induced skin rash.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitomycin C, Irinotecan and Cetuximab | Experimental | Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitomycin C | Drug | Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With an Objective Response | The primary objective of this single-arm phase II study is to determine the response rate (Percentage patients with Complete Response (CR) + Percentage of patients with Partial Response (PR)) for the combination of mitomycin C, irinotecan, and cetuximab in metastatic colorectal cancer with wild type K-Ras. Complete response will be defined as the disappearance of all measurable and evaluable disease for at least 4 weeks without the appearance of new lesions. Partial response will be defined as a decrease in the sum of the longest diameter of target lesions by at least 30% for at least 4 weeks without the appearance of any new lesions. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events | The proportion of patients experiencing hematological and non-hematological toxicities will be summarized. | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Zalupski, M.D. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mitomycin C, Irinotecan and Cetuximab | Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mitomycin C, Irinotecan and Cetuximab | Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Patients With an Objective Response | The primary objective of this single-arm phase II study is to determine the response rate (Percentage patients with Complete Response (CR) + Percentage of patients with Partial Response (PR)) for the combination of mitomycin C, irinotecan, and cetuximab in metastatic colorectal cancer with wild type K-Ras. Complete response will be defined as the disappearance of all measurable and evaluable disease for at least 4 weeks without the appearance of new lesions. Partial response will be defined as a decrease in the sum of the longest diameter of target lesions by at least 30% for at least 4 weeks without the appearance of any new lesions. | The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution. | Posted | 2 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 | Mitomycin C, Irinotecan and Cetuximab | Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death, Cause Unknown | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemolysis | Blood and lymphatic system disorders |
The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Zalupski | University of Michigan Comprehensive Cancer Center | 734-615-3969 | zalupski@umich.edu |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D016685 | Mitomycin |
| D000068818 | Cetuximab |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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| Cetuximab | Drug | Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. |
|
|
| Irinotecan. | Drug | Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Proportion of Patients Experiencing Hematologic and Non-hematologic Adverse Events | The proportion of patients experiencing hematological and non-hematological toxicities will be summarized. | The study was discontinued and not completed due to the death of a co-investigator and a second co-investigator leaving the institution. Since accrual was not completed the proportion of patients experiencing toxicities could not be statistically determined. | Posted | 2 months |
|
|
| 2 |
| 13 |
| 13 |
| 13 |
| Gastrointestinal Obstruction | Gastrointestinal disorders |
|
| Fatigue | General disorders |
|
| Insomnia | Psychiatric disorders |
|
| Photosensitivity | Skin and subcutaneous tissue disorders |
|
| Rash/desquamation | Skin and subcutaneous tissue disorders |
|
| Anorexia | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
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| Dehydration | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Hemorrhoids | Gastrointestinal disorders |
|
| Mucositis/stomatitis | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Dizziness | Nervous system disorders |
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| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders |
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| Neuropathy: sensory | Nervous system disorders |
|
| Watery eye | Eye disorders |
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| Abdominal Pain | Gastrointestinal disorders |
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| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |