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The major purpose of this study is to determine if a new drug called pazopanib decreases lymphedema in subjects previously treated for cancer. Lymphedema, or swelling of the arm, is a result of damage to the lymphatic vessels in the arm during surgery and/or radiation. The damaged vessels can not adequately drain fluid from the arm, resulting in increased pressure and swelling. Pazopanib has not previously been studied as a treatment for lymphedema.
Pazopanib inhibits the growth of blood vessels in tumors by inhibiting a protein called vascular endothelial growth factor (commonly called VEGF). Pazopanib is not currently approved by the US Food and Drug Administration (FDA) and therefore considered an experimental medication.
High levels of VEGF cause blood vessels to leak fluid, increasing the pressure in tumors similar to the increased pressure in lymphedema. Previous studies have found that treatment with pazopanib decreases the fluid pressure in tumors. That is why we think pazopanib might be an effective treatment for lymphedema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pazopanib Treatment | Experimental | Pazopanib 800 mg orally once each day (maximum total duration of treatment = 24 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pazopanib | Drug | Pazopanib will be administered at a starting dose of 800 mg orally once each day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Volume Ipsilateral Lymphedema in Arm | The primary endpoint will be change in excess arm volume (affected arm volume minus unaffected arm volume) compared to baseline. This will be done at Cycle 2 (29 days) and Cycle 6 (174 days). | Baseline through Cycle 6, Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm | Interstitial fluid pressure was reported at 24 hours. This is the difference in the last-first reading, affected arm. To assess the degree of improvement in arm edema as measured by changes in interstitial fluid pressure (ECF volume using an automated device lymphometer) | First 24 hours after drug was administered |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Miller, MD | IU Simon Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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This study was to enroll 14-15 patients. Due to toxicity and enough patients met the definition of response , this study was halted early, leading to a smaller number of subjects analyzed. There were 10 patients at baseline, 7 patients at Cycle 2, Day 1 and 2 patients who completed the 6 cycles of planned treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | All patients who were treated |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All patients who were treated |
| 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 | Change in Volume Ipsilateral Lymphedema in Arm | The primary endpoint will be change in excess arm volume (affected arm volume minus unaffected arm volume) compared to baseline. This will be done at Cycle 2 (29 days) and Cycle 6 (174 days). | All patients with non-missing results. There were 10 patients at baseline, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment. | Posted | Mean | Standard Deviation | mL | Baseline through Cycle 6, Day 1 |
|
|
Adverse Events are reported from the beginning of study until the end of the study, up to 28 weeks.
There were no serious adverse events entered in this trial.
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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 | Overall | All patients who were treated |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VISION-BLURRED VISION | Eye disorders | MedDRA version 9 | Non-systematic Assessment |
This study was to enroll 14-15 patients. Due to toxicity and enough patients met the definition of response, enrollment to this study was halted early, leading to a smaller number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathy Miller, MD | IndianaU | 317-944-0920 | kathmill@iupui.edu |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C516667 | pazopanib |
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| Change in Impedance or ECF Volume in the Arm | Arm impedance was reported at two baseline readings and for Cycle 2, Day 1. To assess the degree of improvement in arm edema as measured by changes in arm impedance (ECF volume using an automated device lymphometer). Data reported is the ratio of the impedance in the affected versus unaffected arm | Baseline, and Cycle 2, Day 1 |
| Number of Patients With Trt Related Grade 2+ AEs | This is the number of patients who had greater than or equal to Grade 2 Adverse Events related to treatment. This also includes the number of patients who had treatment related Grade 2 or greater Adverse Events that lasted more than 2 weeks (14 days) and excluded events of hypertension (labeled as 'special'). | End of Treatment |
| Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions) | The quality of life questionnaire (FACT-B+4 lymphedema questions) was given at various timepoints during the study. The values for the subscales are given for baseline, Cycle 1:Day 1, Cycle 2:Day 1, and Cycle 6:Day 1. Physical Well-Being (PWB; sum of 7 items, point range 0-28) Social /Family Well-Being (SWB, sum of 7-items, point range 0-28) Emotional Well-Being (EWB; sum of 6-items, point range 0-24) Functional Well-Being (FWB; sum of 7-items, point range 0-28) Additional Concerns (BCS; sum of 9-items, point range 0-36) Arm subscale (AS; sum of 5-items, point range 0-20) -- This was not collected in Cycle 1 or 2. Fact-B+4 score=Sum of PWB, SWB, EWB, FWB, BCS, AS, point range 0-164 Trial Outcome Index=Sum of PWB, FWB, BCS, point range 0-92 Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108 Fact-B score=sum of PWB, SWB, EWB, FWB, BCS, point range 0-144 Note: The higher the score, the better the outcome | Baseline through Cycle 6, Day 1 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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|
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| Secondary | Changes in Interstitial Fluid Pressure (ECF Volume) in the Arm | Interstitial fluid pressure was reported at 24 hours. This is the difference in the last-first reading, affected arm. To assess the degree of improvement in arm edema as measured by changes in interstitial fluid pressure (ECF volume using an automated device lymphometer) | All patients with non-missing results at both baseline and at 24 hours. | Posted | Mean | Standard Deviation | mm Hg | First 24 hours after drug was administered |
|
|
|
|
| Secondary | Change in Impedance or ECF Volume in the Arm | Arm impedance was reported at two baseline readings and for Cycle 2, Day 1. To assess the degree of improvement in arm edema as measured by changes in arm impedance (ECF volume using an automated device lymphometer). Data reported is the ratio of the impedance in the affected versus unaffected arm | All patients with non-missing results. This includes 8 patients at the first baseline, 10 patients at the second baseline, and 7 patients at Cycle 2, Day 1. | Posted | Median | Standard Deviation | ratio | Baseline, and Cycle 2, Day 1 |
|
|
|
|
| Secondary | Number of Patients With Trt Related Grade 2+ AEs | This is the number of patients who had greater than or equal to Grade 2 Adverse Events related to treatment. This also includes the number of patients who had treatment related Grade 2 or greater Adverse Events that lasted more than 2 weeks (14 days) and excluded events of hypertension (labeled as 'special'). | All treated patients | Posted | Number | participants | End of Treatment |
|
|
|
| Secondary | Clinical Benefit as Assessed by Quality of Life Questionnaire (FACT-B+4 Lymphedema Questions) | The quality of life questionnaire (FACT-B+4 lymphedema questions) was given at various timepoints during the study. The values for the subscales are given for baseline, Cycle 1:Day 1, Cycle 2:Day 1, and Cycle 6:Day 1. Physical Well-Being (PWB; sum of 7 items, point range 0-28) Social /Family Well-Being (SWB, sum of 7-items, point range 0-28) Emotional Well-Being (EWB; sum of 6-items, point range 0-24) Functional Well-Being (FWB; sum of 7-items, point range 0-28) Additional Concerns (BCS; sum of 9-items, point range 0-36) Arm subscale (AS; sum of 5-items, point range 0-20) -- This was not collected in Cycle 1 or 2. Fact-B+4 score=Sum of PWB, SWB, EWB, FWB, BCS, AS, point range 0-164 Trial Outcome Index=Sum of PWB, FWB, BCS, point range 0-92 Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108 Fact-B score=sum of PWB, SWB, EWB, FWB, BCS, point range 0-144 Note: The higher the score, the better the outcome | All patients with non-missing results. There were 10 patients at baseline/Cycle 1, Day 1, 7 patients at Cycle 2, Day 1, and 2 patients who completed the 6 cycles of treatment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline through Cycle 6, Day 1 |
|
|
|
| 0 |
| 10 |
| 10 |
| 10 |
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY | Gastrointestinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| DIARRHEA | Gastrointestinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| FLATULENCE | Gastrointestinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| PAIN - ABDOMEN NOS | Gastrointestinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| PAIN - ORAL-GUMS | Gastrointestinal disorders | MedDRA version 9 | Non-systematic Assessment |
|
| TASTE ALTERATION (DYSGEUSIA) | Gastrointestinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | MedDRA version 9 | Non-systematic Assessment |
|
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | MedDRA version 9 | Non-systematic Assessment |
|
| SWEATING (DIAPHORESIS) | General disorders | MedDRA version 9 | Non-systematic Assessment |
|
| ALKALINE PHOSPHATASE | Investigations | MedDRA version 9 | Non-systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | MedDRA version 9 | Non-systematic Assessment |
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| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - NECK NOS | Musculoskeletal and connective tissue disorders | MedDRA version 9 | Non-systematic Assessment |
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| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SKIN (CELLULITIS) | Musculoskeletal and connective tissue disorders | MedDRA version 9 | Non-systematic Assessment |
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| PAIN - EXTREMITY-LIMB | Musculoskeletal and connective tissue disorders | MedDRA version 9 | Non-systematic Assessment |
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| PAIN - JOINT | Musculoskeletal and connective tissue disorders | MedDRA version 9 | Non-systematic Assessment |
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| PAIN - NECK | Musculoskeletal and connective tissue disorders | MedDRA version 9 | Non-systematic Assessment |
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| PAIN - BACK | Musculoskeletal and connective tissue disorders | MedDRA version 9 | Non-systematic Assessment |
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| NEUROPATHY: SENSORY | Nervous system disorders | MedDRA version 9 | Non-systematic Assessment |
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| PAIN - HEAD/HEADACHE | Nervous system disorders | MedDRA version 9 | Non-systematic Assessment |
|
| PAIN - NEURALGIA/PERIPHERAL NERVE | Nervous system disorders | MedDRA version 9 | Non-systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA version 9 | Non-systematic Assessment |
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| MOOD ALTERATION - DEPRESSION | Psychiatric disorders | MedDRA version 9 | Non-systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS | Respiratory, thoracic and mediastinal disorders | MedDRA version 9 | Non-systematic Assessment |
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| DERMATOLOGY/SKIN - OTHER (SPECIFY, __) | Skin and subcutaneous tissue disorders | MedDRA version 9 | Non-systematic Assessment |
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| HAIR LOSS/ALOPECIA (SCALP OR BODY) | Skin and subcutaneous tissue disorders | MedDRA version 9 | Non-systematic Assessment |
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| HYPOPIGMENTATION | Skin and subcutaneous tissue disorders | MedDRA version 9 | Non-systematic Assessment |
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| PRURITUS/ITCHING | Skin and subcutaneous tissue disorders | MedDRA version 9 | Non-systematic Assessment |
|
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | MedDRA version 9 | Non-systematic Assessment |
|
| RASH: ACNE/ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA version 9 | Non-systematic Assessment |
|
| RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS) | Skin and subcutaneous tissue disorders | MedDRA version 9 | Non-systematic Assessment |
|
| HOT FLASHES/FLUSHES | Vascular disorders | MedDRA version 9 | Non-systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA version 9 | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
|
| Cylce 1, Day 1 Emotional Well Being |
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| Cycle 1, Day 1 Additional Concerns |
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| Cycle 1, Day 1 FACT-B+4 Score |
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| Cycle 1, Day 1 Trial Outcome Index |
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| Cycle 1, Day 1 FACT G Score |
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| Cycle 1, Day 1 FACT B Score |
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| Cycle 2, Day 1 Physical Well Being |
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| Cycle 2, Day 1 Social Well Being |
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| Cycle 2, Day 1 Functional Well Being |
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| Cycle 2, Day 1 Emotional Well Being |
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| Cycle 2, Day 1 Additional Concerns |
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| Cycle 2, Day 1 FACT-B+4 Score |
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| Cycle 2, Day 1 Trial Outcome Index |
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| Cycle 2, Day 1 FACT G Score |
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| Cycle 2, Day 1 FACT B Score |
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| Cycle 6, Day 1 Physical Well Being |
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| Cycle 6, Day 1 Social Well Being |
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| Cylce 6, Day 1 Functional Well Being |
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| Cylce 6, Day 1 Emotional Well Being |
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| Cycle 6, Day 1 Additional Concerns |
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| Cycle 6, Day 1 FACT-B+4 Score |
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| Cycle 6, Day 1 Trial Outcome Index |
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| Cycle 6, Day 1 FACT G Score |
|
| Cycle 6, Day 1 FACT B Score |
|