Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-01275 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
Not provided
Not provided
Not provided
Risk to benefit ratio not acceptable
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
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RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib when given together with cyclophosphamide and methotrexate to see how well they work in treating patients with metastatic breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of sunitinib malate.
NOTE: *Course 1 includes 2 weeks of sunitinib malate alone followed by sunitinib malate, cyclophosphamide, and methotrexate for 21 days
Blood samples are collected periodically for measurement of circulating tumor cells, circulating endothelial cells, and vascular endothelial growth factor (VEGF) levels.
After completion of study treatment, patients are followed for 30 days and then every 2 months for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sunitinib, Cyclophosphamide, and Methotrexate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclophosphamide | Drug |
| ||
| methotrexate |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose of Sunitinib (Phase I) | Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. Dose limiting toxicity (DLT) defined as: 1) ≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days 2) grade 4 neutropenia associated with fever (1 reading of oral temperature > 38.5 degrees Celsius or 3 readings of oral temperature > 38.0 degrees Celsius in a 24 hour period) 3) ≥ grade 3 thrombocytopenia 4) ≥ grade 3 non-hematologic toxicities, except those that can be controlled to grade 2 or less with appropriate treatment. 5) Inability to resume treatment with any of the study medications within 14 days of stopping due to treatment related toxicity. | 8 weeks |
| Patients With Progression-free Survival (PFS) Greater Than or Equal to 12 Weeks (Phase II) | Progression defined as: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), or appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer). | up to 12 weeks after treatment start date |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. |
Not provided
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of breast cancer with documented progressive disease
Measurable disease as defined by RECIST criteria or evaluable disease
Must have received at least one prior chemotherapy regimen for metastatic breast cancer
Patients with HER2-overexpression disease must have been previously treated with trastuzumab (Herceptin®)
Patients with stable brain metastases are eligible
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
Menopausal status not specified
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy ≥ 12 weeks
Absolute Neutrophil Count (ANC) ≥ 1,000/mm³
Platelet count ≥ 100,000/mm³
Creatinine ≤ 1.5 times upper limit of normal (ULN)
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
Total bilirubin ≤ 1.5 times ULN
Able to take oral medications and maintain hydration
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after treatment
No severe concurrent illness including, but not limited to, any of the following:
Must be able to read and speak English
PRIOR CONCURRENT THERAPY:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Hope S. Rugo, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94115 | United States |
Not provided
Not provided
Not provided
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Phase I patients received escalating doses of sunitinib in a 3x3 design. None of the patients in the phase I study was included in phase II. Phase I patients receiving treatment at the phase II dose were included in the overall efficacy analysis of the phase II study but were not counted toward the enrollment accrual of the phase II study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase I, Dose 1 | One cycle = 21 days Sunitinib only (12.5 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg twice a day (BID) 2 days/week). Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. |
| FG001 | Phase I, Dose 2 | One cycle = 21 days Sunitinib only (25 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. |
| FG002 | Phase I, Dose 3 | One cycle = 21 days Sunitinib only (37.5 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. |
| FG003 | Phase II |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sunitinib, Cyclophosphamide, and Methotrexate | Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Maximum Tolerated Dose of Sunitinib (Phase I) | Patients in each cohort were followed for DLT for at least 8 weeks (2 week lead-in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. Dose limiting toxicity (DLT) defined as: 1) ≥ grade 3 anemia that does not resolve with appropriate growth factors afebrile grade 4 neutropenia that does not resolve with growth factor support after ≥ 7 days 2) grade 4 neutropenia associated with fever (1 reading of oral temperature > 38.5 degrees Celsius or 3 readings of oral temperature > 38.0 degrees Celsius in a 24 hour period) 3) ≥ grade 3 thrombocytopenia 4) ≥ grade 3 non-hematologic toxicities, except those that can be controlled to grade 2 or less with appropriate treatment. 5) Inability to resume treatment with any of the study medications within 14 days of stopping due to treatment related toxicity. | Posted | Number | mg | 8 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I, Dose 1 | One cycle = 21 days Sunitinib only (12.5 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fracture | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal distention | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
Based on published literature indicating significant toxicity and low response rate for combination sunitinib in the treatment of advanced breast cancer, the PI and Breast Oncology Site Committee closed enrollment after accrual of 32 participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hope S. Rugo | University of California, San Francisco | 877-827-3222 | clinicaltrials@ucsf.edu |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D008727 | Methotrexate |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| sunitinib malate | Drug |
|
| laboratory biomarker analysis | Other |
|
| until disease progression, up to 13 months post treatment |
| Duration of Response | Duration of response refers to duration of single partial response observed per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer). | until disease progression up to 13 months post treatment |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment). |
|
|
| Primary | Patients With Progression-free Survival (PFS) Greater Than or Equal to 12 Weeks (Phase II) | Progression defined as: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), or appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer). | Patients who received either 25mg or 37.5mg of sunitinib and were not removed from study due to voluntary withdrawal or PD prior to receiving combination sunitinib and metronomic CM chemotherapy. | Posted | Number | participants | up to 12 weeks after treatment start date |
|
|
|
| Secondary | Overall Response Rate | Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. | Posted | Number | participants | until disease progression, up to 13 months post treatment |
|
|
|
| Secondary | Duration of Response | Duration of response refers to duration of single partial response observed per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial Response (PR): greater than or equal to 50% decrease under baseline in the sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Stable: Does not qualify for complete response, partial response or progression. Progression: 25% increase or an increase of 10 sq. cm (whichever is smaller) in the sum of products of measurable lesions over smallest sum observed (over baseline if no decrease), OR appearance of any lesion which had disappeared, or clear worsening of any evaluable disease, or appearance of any new lesion/site, or failure to return for evaluation due to deteriorating condition (unless deterioration is clearly unrelated to this cancer). | A partial response was only reported for one patient, while a complete response was not recorded for any patients. | Posted | Number | weeks | until disease progression up to 13 months post treatment |
|
|
|
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | Phase I, Dose 2 | One cycle = 21 days Sunitinib only (25 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. | 0 | 7 | 6 | 7 |
| EG002 | Phase I, Dose 3 | One cycle = 21 days Sunitinib only (37.5 mg) for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Patients in each cohort will be followed for at least 8 weeks (2 week lead in with sunitinib and 6 weeks of treatment with sunitinib and metronomic cyclophosphamide and methotrexate) before opening accrual to the next dose level. | 1 | 10 | 8 | 10 |
| EG003 | Phase II |
or
(dose reduction due to a protocol amendment) | 0 | 11 | 11 | 11 |
| abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| activated partial thromboplastin time prolonged | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| alanine aminotransferase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| alkaline phosphatase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| anal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| bacterial vaginosis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| blood blirubin increased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| blood urea nitrogen increased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| breast infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| bruising | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| cognitive disturbance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| cold sore | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| creatinine increased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| desquamation, blistering | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| dry eyes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dry mucous membrane | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| dullness in lungs | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dysgeusia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| ear pain | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| edema limbs | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| esophagoscopy abnormal | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| floaters | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| gastroesophageal reflux disorder | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| gastrotitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| groin pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| hand stiffness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| heavy eyelid | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| hip pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| hot flashes | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypochloremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| impaired LV | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| jaundice | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| lightheadedness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| loss of function in right hand | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| lymphocyte count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| myositis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| neutrophil count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| night sweats | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| non-cardiac chest pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| numbness to chin | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| oral pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| petechia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| psoriasis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| puffy eyelid | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| pulsing in ear | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| rib pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| sinus bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| sinusitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| skin peeling | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| spider bite | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| thromboembolic event | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| upper respiratory infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| urinary incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| voice alteration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| warmth to chest wall | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| white blood cell decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| 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 |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D007211 | Indoles |