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| ID | Type | Description | Link |
|---|---|---|---|
| HUM 44800 | Other Identifier | University of Michigan IRBMED |
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The purpose of this study is to explore how a sarcoma is affected by and the side effects of a newer combination of chemotherapy drugs(gemcitabine and docetaxel)as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.
The purpose of this study is to explore the relative activity and toxicity of a newer combination of chemotherapy drugs, gemcitabine and docetaxel, as compared to a standard combination of chemotherapy drugs, ifosfamide and doxorubicin.
Ifosfamide and Doxorubicin, given in combination, are recognized as a standard of care for some types of sarcoma. Both gemcitabine and docetaxel are approved by the US Food and Drug Administration (FDA) for the treatment of some cancers (cancers of the pancreas, lung) because patients with those cancers treated with either gemcitabine or docetaxel experienced shrinkage of their tumor or improvement in their symptoms. However, neither gemcitabine or docetaxel is approved for sarcoma, but the combination of gemcitabine and docetaxel is a standard treatment for advanced sarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| doxorubicin and ifosfamide | Active Comparator |
| |
| gemcitabine and docetaxel | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ifosfamide and doxorubicin vs gemcitabine and docetaxel | Drug | Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor. Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4. All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Hospitalized in Each Arm. | To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Alive Without Disease at 2 Years | Disease-free survival | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Schuetze, MD, PhD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27544129 | Derived | Davis EJ, Zhao L, Lucas DR, Schuetze SM, Baker LH, Zalupski MM, Thomas D, Chugh R. SPARC expression in patients with high-risk localized soft tissue sarcoma treated on a randomized phase II trial of neo/adjuvant chemotherapy. BMC Cancer. 2016 Aug 20;16:663. doi: 10.1186/s12885-016-2694-2. |
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84 patients were enrolled and randomized at the University of Michigan, however 4 patients withdrew consent prior to treatment. 80 patients began study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxorubicin and Ifosfamide | Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor. All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| FG001 | Gemcitabine and Docetaxel | Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4. All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxorubicin and Ifosfamide | Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor. All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection. |
| BG001 | Gemcitabine and Docetaxel | Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4. All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection. |
| BG002 | Total | Total of all reporting groups |
| 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 | Median | Full Range | years |
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| 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 | Percentage of Patients Hospitalized in Each Arm. | To contrast the proportion of treated patients hospitalized subsequent to treatment with gemcitabine and docetaxel as compared to doxorubicin and ifosfamide as neoadjuvant or adjuvant therapy of poor prognosis soft tissue sarcoma. | Posted | Number | percentage of patients hospitalized | 12 weeks |
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| Secondary | The Percentage of Patients Alive Without Disease at 2 Years | Disease-free survival | Posted | Number | percentage of patients | 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 | Doxorubicin and Ifosfamide | Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor. All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection. | 12 | 37 | 30 | 37 | ||
| EG001 | Gemcitabine and Docetaxel | Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4. All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection. | 12 | 43 | 33 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ataxia (incoordination) | Musculoskeletal and connective tissue disorders |
| |||
| Cardiac ischemia/infarction | Cardiac disorders |
| |||
| Cardiac troponin I (cTnI) | Cardiac disorders |
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| Dehydration | Metabolism and nutrition disorders |
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| Dysphagia (difficulty swallowing) | Gastrointestinal disorders |
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| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders |
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| Esophagitis | Gastrointestinal disorders |
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| Febrile neutropenia | Blood and lymphatic system disorders |
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| Hemoglobin | Blood and lymphatic system disorders |
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| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations |
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| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders |
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| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders |
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| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders |
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| Colitis | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Edema: limb | General disorders |
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| Fever | General disorders |
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| Hemorrhage, pulmonary/upper respiratory | Vascular disorders |
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| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations |
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| Nausea | Gastrointestinal disorders |
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| Thrombosis/thrombus/embolism | Vascular disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations |
| |||
| Ataxia (incoordination) | Musculoskeletal and connective tissue disorders |
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| Cardiac ischemia/infarction | Cardiac disorders |
| |||
| Cardiac troponin I (cTnI) | Cardiac disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
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| Dysphagia (difficulty swallowing) | Gastrointestinal disorders |
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| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders |
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| Esophagitis | Gastrointestinal disorders |
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| Fatigue (asthenia, lethargy, malaise) | General disorders |
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| Febrile neutropenia | Blood and lymphatic system disorders |
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| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders |
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| Hemoglobin | Blood and lymphatic system disorders |
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| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations |
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| Infection with unknown ANC | Infections and infestations |
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| Leukocytes (total WBC) | Blood and lymphatic system disorders |
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| Lymphopenia | Blood and lymphatic system disorders |
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| Mucositis/stomatitis (clinical exam) | Investigations |
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| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders |
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| Pain | General disorders |
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| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders |
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| Platelets | Blood and lymphatic system disorders |
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| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders |
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| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders |
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| Syncope (fainting) | Nervous system disorders |
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| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders |
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| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders |
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| Colitis | Gastrointestinal disorders |
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| Constipation | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Edema: limb | General disorders |
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| Fever | General disorders |
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| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and lymphatic system disorders |
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| Hemorrhage, pulmonary/upper respiratory | Vascular disorders |
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| Infection with Grade 3 or 4 neutrophils | Infections and infestations |
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| Infection with normal ANC or Grade 1 or 2 neutrophils | Infections and infestations |
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| Nausea | Gastrointestinal disorders |
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| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders |
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| Thrombosis/thrombus/embolism | Vascular disorders |
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| Vomiting | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Scott Schuetze, M.D., Ph.D. | University of Michigan Comprehensive Cancer Center | 1-800-865-1125 | scotschu@umich.edu |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007069 | Ifosfamide |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| Male |
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