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| ID | Type | Description | Link |
|---|---|---|---|
| MSKCC-07044 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating patients with previously untreated germ cell tumors.
OBJECTIVES:
OUTLINE: Patients receive paclitaxel IV over 120-180 minutes on days 1 and 2, cisplatin IV over 30 minutes and ifosfamide IV over 120 minutes on days 1-5, and pegfilgrastim subcutaneously on day 6. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Some patients may required surgery after chemotherapy and, if viable non-teratomatous germ cell tumor is found in the surgical specimen and there is no interval disease progression, these patients may receive 1-2 more courses of chemotherapy after surgery.
After completion of study treatment, patients are followed up at 28 days and then every 2 months for up to 1 year.
PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel, Ifosfamide, and Cisplatin | Experimental | -Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegfilgrastim | Biological |
| ||
| cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complete Response | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 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 | Up to 8 years |
| Percentage of Participants With Progression Free Survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed germ cell tumor meeting 1 of the following criteria:
Poor risk, defined by any of the following:
Testis or retroperitoneal primary site nonseminoma histology without visceral metastases but with "poor-risk" markers, defined by any of the following:
Testis or retroperitoneal primary site nonseminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values):
Mediastinal primary site nonseminoma histology regardless of serum tumor marker levels or presence/absence of visceral metastases
Modified intermediate risk, defined by any of the following:
Testis or retroperitoneal primary site nonseminoma histology with no nonpulmonary visceral metastases, and with any of the following serum marker values:
Seminoma histology with one or more nonpulmonary visceral metastases, including any of the following (regardless of serum tumor marker values or primary site):
Previously untreated disease
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Feldman, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Robert J. Motzer, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90089-9181 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Protocol Open to Accrual 03/27/2007 Protocol Closed to Accrual 8/13/2013 Primary Completion Date 06-13-2016 Recruitment Location is the medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel, Ifosfamide, and Cisplatin | -Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. pegfilgrastim cisplatin ifosfamide paclitaxel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| ifosfamide | Drug |
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| paclitaxel | Drug |
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Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 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 |
| 3 years |
| Number of Patients With Treatment Related Toxicity | Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0 | 3 years |
| Memorial Sloan-Kettering Cancer Center |
| New York |
| New York |
| 10065 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel, Ifosfamide, and Cisplatin | -Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. pegfilgrastim cisplatin ifosfamide paclitaxel |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Rate of Complete Response | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions | Posted | Count of Participants | Participants | 3 years |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 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 | Posted | Median | Full Range | years | Up to 8 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Progression Free Survival | Progression Free Survival at 3 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as 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 | Posted | Number | 95% Confidence Interval | percentage of patients | 3 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Treatment Related Toxicity | Toxicity evaluated and graded according to the National Cancer Institute, Version 3.0 | Posted | Count of Participants | Participants | 3 years |
|
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Day 1, 8 and 15 during each treatment cycle (1 cycle = 21 days). Follow up evaluation will be assessed after 28 days off study as often as every 4-8 weeks for the first year for patients who complete study or withdraw for reason other than progression of disease. For patients who come off study for disease progression, follow-up as often as every 8 weeks for the first year.
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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 | Paclitaxel, Ifosfamide, and Cisplatin | -Paclitaxel is administered first, 120 mg/m2 on days 1 and 2 every three weeks for four cycles. Cisplatin is administered at 20 mg/m2 over approximately 30 minutes daily for five days every three weeks for four courses. -The ifosfamide is given last with 1200 mg/m2 daily for five days every three weeks for four cycles. pegfilgrastim cisplatin ifosfamide paclitaxel | 5 | 60 | 34 | 60 | 60 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy/Immunology, other | Immune system disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Atrial tachycardia/Paroxysmal Atrial Tachycardia | Cardiac disorders | Systematic Assessment |
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| Cardiac General, other | Cardiac disorders | Systematic Assessment |
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| Chyle or lymph leakage | Vascular disorders | Systematic Assessment |
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| Confusion | Psychiatric disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Creatinine | Investigations | Systematic Assessment |
| ||
| Cystitis | Renal and urinary disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fever (in the absence of neutropenia) | General disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Hemorrhage, Duodenum | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemorrhage, Esophagus | Gastrointestinal disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Infection w/ Gr 3/4 Neut, Kidney | Infections and infestations | Systematic Assessment |
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| Leukocytes | Investigations | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neutrophils/granulocytes | Investigations | Systematic Assessment |
| ||
| Obstruction, GU - Ureter | Renal and urinary disorders | Systematic Assessment |
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| Pain - Abdomen NOS | Gastrointestinal disorders | Systematic Assessment |
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| Pain - Back | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain - Chest/thorax NOS | General disorders | Systematic Assessment |
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| Pain - Throat/pharynx/larynx | General disorders | Systematic Assessment |
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| Platelets | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Thrombosis/embolism | Vascular disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukocytes | Investigations | Systematic Assessment |
| ||
| Neutrophils/granulocytes | Investigations | Systematic Assessment |
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| Platelets | Investigations | Systematic Assessment |
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| ALT | Investigations | Systematic Assessment |
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| Neuropathy: sensory | Nervous system disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| AST | Investigations | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Alkaline phosphatase | Investigations | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Lymphopenia | Investigations | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Hyperbilirubinemia | Investigations | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| INR | Investigations | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Amylase | Investigations | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Mucositis - oral cavity | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pain - Joint | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Darren Feldman, MD | Memorial Sloan Kettering Cancer Center | 646-422-4491 | feldmand@mskcc.org |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D010051 | Ovarian Neoplasms |
| D013724 | Teratoma |
| C563236 | Testicular Germ Cell Tumor |
| D013736 | Testicular Neoplasms |
| D018236 | Carcinoma, Embryonal |
| D018239 | Seminoma |
| D018240 | Endodermal Sinus Tumor |
| D004407 | Dysgerminoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D013733 | Testicular Diseases |
| D018237 | Germinoma |
| D008649 | Mesonephroma |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
| D002945 | Cisplatin |
| D007069 | Ifosfamide |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| 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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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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