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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
CMF (cyclophosphamide, methotrexate, fluorouracil) is used to treat early stage breast cancer. The combination, of these three drugs, has been used for approximately 30 years in the treatment of breast cancer, and has been shown to be safe and effective. It is usually given every 3 weeks. Doctors believe, based on other breast cancer trials, that giving this type of chemotherapy in a shorter amount of time, every 2 weeks or sooner, instead of every 3 weeks, may be better. The purpose of this study is to test the safety of these drugs, given every 2 weeks or sooner, to treat breast cancer. Other breast cancer chemotherapy regimens have shown to be more beneficial when the drugs are given more frequently.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim | Drug | C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients Who Completed 8 Cycles. | the study regimen is deemed feasible and tolerable for patients with ANC > 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Drullinsky, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan-Kettering at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan-Kettering Cancer Center at Commack |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A (CMF at 14 Day Intervals) | This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim. cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan-Kettering Cancer Center at Mercy | Rockville Centre | New York | 11570 | United States |
| Memoral Sloan-Kettering Cancer Center at Phelps | Sleepy Hollow | New York | 10591 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A (CMF at 14 Day Intervals) | This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim. cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | The Number of Patients Who Completed 8 Cycles. | the study regimen is deemed feasible and tolerable for patients with ANC > 1.5 on day 1 of treatment for all 8 cycles and absence of grade 3 or higher non-hematologic toxicity, excluding alopecia, nausea/vomiting and bone pain We will also evaluate the total number of days needed to complete all 8 cycles. | Posted | Number | participants | 2 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 | Cohort A (CMF at 14 Day Intervals) | This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim. cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle. | 2 | 38 | 19 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela Drullinksy | Memorial Sloan Kettering Cancer Center | 516-256-3955 | drullinp@mskcc.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D008727 | Methotrexate |
| D005472 | Fluorouracil |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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