| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00154 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CDR0000544831 | |||
| 2U10CA045809-17 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin together with pegfilgrastim works in treating patients with metastatic or unresectable bladder cancer or urinary tract cancer and kidney dysfunction. Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.
PRIMARY OBJECTIVES:
I. Assess the efficacy of gemcitabine hydrochloride, paclitaxel, doxorubicin hydrochloride, and pegfilgrastim, in terms of response rate, in patients with metastatic or unresectable transitional cell carcinoma of the bladder or urinary tract and renal insufficiency.
SECONDARY OBJECTIVES:
I. Assess the safety and tolerability of this regimen in these patients. II. Determine the median time to progression in patients treated with this regimen.
III. Determine the median survival duration in patients treated with this regimen.
IV. Assess the safety and efficacy of pegfilgrastim in these patients.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin hydrochloride intravenous (IV) over 20 minutes, paclitaxel IV over 60 minutes, gemcitabine hydrochloride IV over 90 minutes, and pegfilgrastim subcutaneously on day 1. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine, Paclitaxel and Doxorubicin | Experimental | Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 min; Doxorubicin 40 mg/m^2 IV over 20 min; treatment may repeat every 2 weeks for up to nine courses. Injection of Pegfilgrastim on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemcitabine hydrochloride | Drug | Gemcitabine 900 mg/m^2 IV over 90 minutes repeat every 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | The percentage of participants with either Complete Response (CR) or Partial Response (PR) in their disease burden based upon the rules of the Response Evaluation Criteria in Solid Tumors (RECIST). A participant with of all of the lesions disappearing is a CR. A participant with at least a 30 percent decrease in the measured lesions is a PR. | Up to 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease | The overall survival was determined by grouping participants based upon their response based on RECIST. The groups are Complete Response(CR): All the cancerous lesion disappear, Partial Response (PR): All the measured lesions decrease by at least 30 percent, and Stable Disease(SD): No significant change in the disease burden. OS of complete response or partial response participants were compared to the reference group of stable disease participants in a Hazard Ratio(HR). If HR is greater than 1, the experimental group has a better outcome than the reference group. If HR is less than 1, the reference group has the better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lance Pagliaro, MD, BA | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield | Missouri | 65802 | United States | ||
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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One patient withdrew from the study without receiving treatment.
Recruitment period: April 24, 2007 to November 10, 2011. All recruitment done within Community Clinical Oncology Programs (CCOP) medical clinics, specifically The University of Texas MD Anderson Cancer Center and the Ozarks Regional CCOP.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine, Paclitaxel and Doxorubicin | Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 minutes; Doxorubicin 40 mg/m^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paclitaxel | Drug | 135 mg/m^2 IV over 1 hour |
|
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| Doxorubicin hydrochloride | Drug | Doxorubicin 40 mg/m^2 IV over 20 minutes |
|
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| Pegfilgrastim | Drug | Subcutaneously injection on day 1. |
|
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| Registration Date of each participant for up to three years or death whichever came first |
| Safety and Efficacy of Same-day Pegfilgrastim | Determined the number of participants who had either a fever due to abnormally low level of neutrophils, a type of white blood cell, on the day of study drug treatment, or the participants who had the study drug treatment delayed due to an abnormally low level of neutrophils. | Up to 3 years |
| University of Texas MD Anderson Cancer Center |
| Houston |
| Texas |
| 77030 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine, Paclitaxel and Doxorubicin | Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 minutes; Doxorubicin 40 mg/m^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy. |
| 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 |
| ||||||||||||||||||
| 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 | Objective Response Rate | The percentage of participants with either Complete Response (CR) or Partial Response (PR) in their disease burden based upon the rules of the Response Evaluation Criteria in Solid Tumors (RECIST). A participant with of all of the lesions disappearing is a CR. A participant with at least a 30 percent decrease in the measured lesions is a PR. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease | The overall survival was determined by grouping participants based upon their response based on RECIST. The groups are Complete Response(CR): All the cancerous lesion disappear, Partial Response (PR): All the measured lesions decrease by at least 30 percent, and Stable Disease(SD): No significant change in the disease burden. OS of complete response or partial response participants were compared to the reference group of stable disease participants in a Hazard Ratio(HR). If HR is greater than 1, the experimental group has a better outcome than the reference group. If HR is less than 1, the reference group has the better outcome. | Posted | Number | 95% Confidence Interval | Hazard Ratio | Registration Date of each participant for up to three years or death whichever came first |
|
| |||||||||||||||||||||||||||
| Secondary | Safety and Efficacy of Same-day Pegfilgrastim | Determined the number of participants who had either a fever due to abnormally low level of neutrophils, a type of white blood cell, on the day of study drug treatment, or the participants who had the study drug treatment delayed due to an abnormally low level of neutrophils. | Thirty-two patients (82%) received Pegfilgrastim immediately after chemotherapy on day 1 of the cycle. | Posted | Number | participants | Up to 3 years |
|
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Adverse event collection during therapy may continue for 12 weeks (6 cycles) with possible 3 additional cycles (6 weeks) beyond a documented complete response.
AEs were graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE), version 4.0.
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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 | Gemcitabine, Paclitaxel and Doxorubicin | Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 minutes; Doxorubicin 40 mg/m^2 IV over 20 minutes; treatment may repeat every 2 weeks for up to nine courses. Subcutaneous Injection of Pegfilgrastim on day 1 or 2 of each course, after chemotherapy. | 39 | 39 | 34 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Granulocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Thrombocytopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Neutropenic Fever | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hand Foot Syndrome | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | 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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| Platelet Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin and Subcutaneous Tissue Disorders - Nodule | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Creatinine Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Peripheral Motor Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin and Subcutaneous Tissue Disorders - Redness/Irritation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Edema Limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Alkaline Phosphatase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Sinus Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| BUN | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Mucositis Oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Carbon Monoxide Diffusing Capacity Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Acute Coronary Syndrome | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Cardiac Troponin I Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Watering Eyes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| White Blood Cell Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hemoglobinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Neutrophil Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Glucose Intolerance | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| INR Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Hemoglobin Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Flank Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Cholesterol High | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Accessory Nerve Disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Sensory Soles of Feet |
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| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Nervous System Disorders - Sensory | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Phosphorus High | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Activated Partial Thromboplastin Time Prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Alkalosis | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| CPK Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Hearing Impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
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| Lymphocyte Count Decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Palmar-Plantar Erythrodysesthesia Syndrome | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Bladder Spasm | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary Tract Pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary Frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Gait Disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Chest Pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Agitation | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Dehydration | Social circumstances | CTCAE (4.0) | Systematic Assessment |
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| Weight Loss | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Hepatobiliary Disorders | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary Incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Vaginal Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Skin Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
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| Thromboembolic Event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Muscle Weakness Lower Limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Muscle Weakness Left-Sided | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nizar M Tannir, MDChair Ad Interim, Genitourinary Medical Oncology | UT MD Anderson Cancer Center, Community Clinical Oncology Program Research Base | 713-563-7265 | ntannir@mdanderson.org |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D014523 | Urethral Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D014522 | Urethral Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D004317 | Doxorubicin |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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|
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