Sorafenib Therapy Prior to Radiofrequency Ablation for Intermediate Sized Hepatocellular Cancer
Study Details
Study Description
Brief Summary
The purpose of this research study is to determine if sorafenib improves the effectiveness of a procedure called radiofrequency ablation (RFA) for the treatment of hepatocellular cancer (HCC). Radiofrequency ablation has been used to treat many types of tumors, including hepatocellular cancers. During RFA a needle is inserted into the tumor tissue and heat is used to kill the tumor cells. Sorafenib has been approved by the FDA for the treatment of hepatocellular cancer that cannot be treated with surgery. Pre-clinical data suggests that sorafenib may improve the efficacy of RFA.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Hepatocellular cancer (HCC) has a poor prognosis with increasing mortality in the United States. Because HCC generally develops in patients with underlying liver disease, resection is often not possible. Liver transplant improves survival for HCC patients but given the national organ donor shortage often patients have to wait a considerable time for transplant. Liver-directed therapies such as radiofrequency ablation (RFA) remain important tools to control tumor growth and to potentially "bridge" patients to liver transplant. However, liver-directed therapies for HCC tumors greater than 3cm in size are suboptimal, leaving a critical unmet need.
Antiangiogenic systemic agents, such as oral sorafenib, reduce tumor blood flow and have been shown to improve RFA efficacy in animal and in computer models.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sorafenib Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). |
Drug: Sorafenib
Other Names:
Procedure: radiofrequency ablation
Other Names:
|
| Placebo Comparator: Placebo Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). |
Procedure: radiofrequency ablation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Coagulation Zone Diameter-Short Axis [Up to day 50 from study enrollment (target 30 days after RFA)]
The size of the coagulation zone was determined on CT imaging obtained after RFA for the single index tumor.
- Coagulation Zone Diameter-Long Axis [Up to day 50 from study enrollment (target 30 days after RFA)]
The size of the coagulation zone was determined on CT imaging obtained after RFA for the single index tumor.
- Coagulation Zone Volume [Up to day 50 from study enrollment (target 30 days after RFA)]
The size of the coagulation zone was determined on CT imaging obtained after RFA for the single index tumor.
Secondary Outcome Measures
- Feasibility Rate [Up to day 14 since enrollment]
Feasibility rate is defined as the percentage of participants completing radiofrequency ablation following 9 days of sorafenib or placebo therapy.
- Number of Treatment-Related Grade 1-4 Adverse Events (AEs) by Day 9 [Day 9]
AEs were assessed based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v3.0). The number of Grade 1-4 AEs with treatment attribution possibly, probably or definitely related up to day 9 of study drug treatment were counted for this outcome. Worst grade by patient within AE type was calculated. Participants could have multiple different AE types within a grade.
- Number of Treatment-Related Grade 1-4 Adverse Events (AEs) on Day of Radiofrequency Ablation (RFA) [Up to day 14 (target day 10 RFA)]
AEs were assessed based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v3.0). The number of Grade 1-4 AEs with treatment attribution possibly, probably or definitely related on day of RFA treatment were counted for this outcome. Worst grade by patient within AE type was calculated. Participants could have multiple AE types within a grade.
- Number of Treatment-Related Grade 1-4 Adverse Events (AEs) One Month After Radiofrequency Ablation (RFA) [Up to day 40 post RFA (target 30 days)]
AEs were assessed based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v3.0). The number of Grade 1-4 AEs with treatment attribution possibly, probably or definitely related one month after RFA treatment were counted for this outcome. Worst grade by patient within AE type was calculated. Participants could have multiple AE types within a grade.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Confirmed hepatocellular cancer (HCC) by pathology or by NCCN imaging guidelines
-
All HCC stages are allowed. May be a liver transplant candidate.
-
At least one tumor (index tumor) accurately measured as 3.5-7cm in diameter (long and short axis diameter to be recorded, but only one needs to meet this criteria) on baseline imaging.
-
No prior therapy for the index tumor
-
No prior systemic treatment for HCC within 4 weeks and no prior anti-VEGF therapy within 8 weeks of study entry.
-
Life expectancy > 8 weeks.
-
ECOG >=0 or 1
-
RFA clinically indicated for index tumor.
-
Acceptable overall RFA and anesthesia risk.
-
Adequate bone marrow, liver and renal function: Hemoglobin >9.0 g/dl; Absolute neutrophil count (ANC)>1,500/mm3; Platelet count correctable to >50,000/mm3; compensated liver function (Child-Turcotte-Pugh A, B7 or B8); Creatinine <1.5 times ULN; INR correctable to <1.5.
-
Ability to take oral medication and no evidence of impaired absorption.
Exclusion Criteria
-
Urgent treatment of the index tumor anticipated.
-
Participants who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Participants currently receiving any other study agents.
-
Known brain metastases
-
History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib.
-
Participants receiving medications or substances that are inducers of CYP3A4 (rifampicin, St. John's wort, phenytoin, carbamazepine, phenobarbital and dexamethasone) or that are metabolized/eliminated by predominantly UGT1A1 pathway or by CYP2B6 and CYP2C8.
-
Decompensated liver disease
-
Uncontrolled hypertension
-
Thrombolic or embolic events within the past 6 months.
-
Hemorrhage/bleeding event within 4 weeks
-
Serious non-healing wound, ulcer, or bone fracture.
-
Evidence of severe or uncorrectable bleeding diathesis or coagulopathy
-
Major surgery, open biopsy or significant traumatic injury within 4 weeks of study entry.
-
Contraindication to or inability to undergo the RFA procedure,
-
Contraindication to or inability to undergo imaging with MRI
-
Uncontrolled intercurrent illness
-
Individuals with a history of a different malignancy unless disease-free for at least 5 years and are deemed by the Investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
-
HIV-positive individuals on combination antiretroviral therapy
For additional inclusion/exclusion criteria details contact Study Site.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
| 2 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- Brigham and Women's Hospital
- Bayer
- Onyx Therapeutics, Inc.
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Andrea Bullock, MD, MPH, Beth Israel Deaconess Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 08-256
- K23CA139005
- IST000508
Study Results
Participant Flow
| Recruitment Details | Participants enrolled from June 2009 through August 2013. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Sorafenib | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). | Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). |
| Period Title: Overall Study | ||
| STARTED | 10 | 10 |
| Started Treatment | 9 | 10 |
| Evaluable RFA | 7 | 8 |
| COMPLETED | 9 | 9 |
| NOT COMPLETED | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Sorafenib | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). | Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). | Total of all reporting groups |
| Overall Participants | 10 | 10 | 20 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
69
(10)
|
66
(11)
|
68
(10)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2
20%
|
2
20%
|
4
20%
|
| Male |
8
80%
|
8
80%
|
16
80%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1
10%
|
0
0%
|
1
5%
|
| Not Hispanic or Latino |
8
80%
|
7
70%
|
15
75%
|
| Unknown or Not Reported |
1
10%
|
3
30%
|
4
20%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
10
100%
|
10
100%
|
20
100%
|
| Present Liver Cirrhosis (Count of Participants) | |||
| Count of Participants [Participants] |
10
100%
|
10
100%
|
20
100%
|
| Present Portal Vein Thrombosis (Count of Participants) | |||
| Count of Participants [Participants] |
1
10%
|
5
50%
|
6
30%
|
| Tumor Size - Short Axis (centimeters) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [centimeters] |
4.4
(1.3)
|
4.4
(1.4)
|
4.4
(1.3)
|
| Tumor Size - Long Axis (centimeters) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [centimeters] |
4.9
(1.7)
|
5.3
(1.3)
|
5.1
(1.5)
|
Outcome Measures
| Title | Coagulation Zone Diameter-Short Axis |
|---|---|
| Description | The size of the coagulation zone was determined on CT imaging obtained after RFA for the single index tumor. |
| Time Frame | Up to day 50 from study enrollment (target 30 days after RFA) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is comprised of all participants who completed treatment ending with day 10 RFA. |
| Arm/Group Title | Sorafenib | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). | Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [millimeters] |
36.0
(7.8)
|
35.1
(8.8)
|
| Title | Coagulation Zone Diameter-Long Axis |
|---|---|
| Description | The size of the coagulation zone was determined on CT imaging obtained after RFA for the single index tumor. |
| Time Frame | Up to day 50 from study enrollment (target 30 days after RFA) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is comprised of all participants who completed treatment ending with RFA. |
| Arm/Group Title | Sorafenib | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). | Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [millimeters] |
42.4
(9.2)
|
44.1
(7.8)
|
| Title | Coagulation Zone Volume |
|---|---|
| Description | The size of the coagulation zone was determined on CT imaging obtained after RFA for the single index tumor. |
| Time Frame | Up to day 50 from study enrollment (target 30 days after RFA) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is comprised of all participants who completed treatment ending with RFA. |
| Arm/Group Title | Sorafenib | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). | Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). |
| Measure Participants | 9 | 9 |
| Mean (Standard Deviation) [centimeters^3] |
30.7
(24.6)
|
30.5
(21.5)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sorafenib, Placebo |
|---|---|---|
| Comments | Assuming the two trial arms were independent, the standard deviation was 0.5cm for both arms and a sample size of 16 evaluable patients (8 per arm), the study had an 84% power at a 5% (two-sided) significance level to detect 0.8cm difference in ablation zone size. In order to allow a 20% drop-out rate, a total of 20 subjects were accrued. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .794 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Feasibility Rate |
|---|---|
| Description | Feasibility rate is defined as the percentage of participants completing radiofrequency ablation following 9 days of sorafenib or placebo therapy. |
| Time Frame | Up to day 14 since enrollment |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is comprised of all enrolled participants. |
| Arm/Group Title | Sorafenib | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). | Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). |
| Measure Participants | 10 | 10 |
| Number (90% Confidence Interval) [percentage of particpants] |
90
|
90
|
| Title | Number of Treatment-Related Grade 1-4 Adverse Events (AEs) by Day 9 |
|---|---|
| Description | AEs were assessed based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v3.0). The number of Grade 1-4 AEs with treatment attribution possibly, probably or definitely related up to day 9 of study drug treatment were counted for this outcome. Worst grade by patient within AE type was calculated. Participants could have multiple different AE types within a grade. |
| Time Frame | Day 9 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is comprised of all treated participants. |
| Arm/Group Title | Sorafenib | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). | Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). |
| Measure Participants | 9 | 10 |
| Number [adverse events] |
8
|
4
|
| Title | Number of Treatment-Related Grade 1-4 Adverse Events (AEs) on Day of Radiofrequency Ablation (RFA) |
|---|---|
| Description | AEs were assessed based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v3.0). The number of Grade 1-4 AEs with treatment attribution possibly, probably or definitely related on day of RFA treatment were counted for this outcome. Worst grade by patient within AE type was calculated. Participants could have multiple AE types within a grade. |
| Time Frame | Up to day 14 (target day 10 RFA) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is comprised of all participants who completed treatment ending with RFA. |
| Arm/Group Title | Sorafenib | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). | Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). |
| Measure Participants | 9 | 9 |
| Number [adverse events] |
5
|
4
|
| Title | Number of Treatment-Related Grade 1-4 Adverse Events (AEs) One Month After Radiofrequency Ablation (RFA) |
|---|---|
| Description | AEs were assessed based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v3.0). The number of Grade 1-4 AEs with treatment attribution possibly, probably or definitely related one month after RFA treatment were counted for this outcome. Worst grade by patient within AE type was calculated. Participants could have multiple AE types within a grade. |
| Time Frame | Up to day 40 post RFA (target 30 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is comprised of all treated participants who were evaluable for AEs at day40. |
| Arm/Group Title | Sorafenib | Placebo |
|---|---|---|
| Arm/Group Description | Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). | Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). |
| Measure Participants | 8 | 8 |
| Number [adverse events] |
8
|
4
|
Adverse Events
| Time Frame | Adverse events were collected on treatment days 1-10 and the day 40 follow-up visit. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term. The analysis population is all treated patients (n=1 dropped out before starting treatment. | |||
| Arm/Group Title | Sorafenib | Placebo | ||
| Arm/Group Description | Participants received a nine-day course of oral sorafenib 400 mg twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). Sorafenib radiofrequency ablation | Participants received a nine-day course of placebo pills twice a day and radiofrequency ablation (RFA) on Day 10. Tumors in each group underwent RFA using a standard regimen (1 cm tip, 70 ± 2º C, 5 min). radiofrequency ablation | ||
All Cause Mortality |
||||
| Sorafenib | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/10 (0%) | ||
Serious Adverse Events |
||||
| Sorafenib | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/9 (11.1%) | 1/10 (10%) | ||
| Hepatobiliary disorders | ||||
| Liver, hemorrhage | 0/9 (0%) | 1/10 (10%) | ||
| Investigations | ||||
| Leukocytes | 1/9 (11.1%) | 0/10 (0%) | ||
| Lymphopenia | 1/9 (11.1%) | 0/10 (0%) | ||
| AST, SGOT | 1/9 (11.1%) | 0/10 (0%) | ||
| Bilirubin | 1/9 (11.1%) | 0/10 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Sorafenib | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/9 (100%) | 10/10 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Hematologic-other | 2/9 (22.2%) | 1/10 (10%) | ||
| Hemoglobin | 4/9 (44.4%) | 3/10 (30%) | ||
| Hemolysis | 0/9 (0%) | 1/10 (10%) | ||
| Cardiac disorders | ||||
| Cardiac-other | 1/9 (11.1%) | 0/10 (0%) | ||
| Palpitations | 0/9 (0%) | 1/10 (10%) | ||
| Sinus tachycardia | 1/9 (11.1%) | 0/10 (0%) | ||
| Supraventricular arrhythmia NOS | 0/9 (0%) | 1/10 (10%) | ||
| Ear and labyrinth disorders | ||||
| Hearing w/o audiogr not in monitor prg | 0/9 (0%) | 1/10 (10%) | ||
| Hearing w/w-o audiogr in monitor prg | 0/9 (0%) | 2/10 (20%) | ||
| Hearing-other | 0/9 (0%) | 1/10 (10%) | ||
| Endocrine disorders | ||||
| Endocrine-other | 1/9 (11.1%) | 0/10 (0%) | ||
| Eye disorders | ||||
| Ocular-other | 0/9 (0%) | 1/10 (10%) | ||
| Gastrointestinal disorders | ||||
| Abdomen, pain | 3/9 (33.3%) | 3/10 (30%) | ||
| Ascites (non-malignant) | 2/9 (22.2%) | 3/10 (30%) | ||
| Constipation | 3/9 (33.3%) | 0/10 (0%) | ||
| Diarrhea w/o prior colostomy | 4/9 (44.4%) | 3/10 (30%) | ||
| Distention/bloating, abdominal | 2/9 (22.2%) | 3/10 (30%) | ||
| Dry mouth | 0/9 (0%) | 1/10 (10%) | ||
| GI-other | 2/9 (22.2%) | 3/10 (30%) | ||
| Lower GI, hemorrhage NOS | 2/9 (22.2%) | 0/10 (0%) | ||
| Muco/stomatitis (symptom) oral cavity | 1/9 (11.1%) | 0/10 (0%) | ||
| Nausea | 2/9 (22.2%) | 3/10 (30%) | ||
| Oral cavity, pain | 1/9 (11.1%) | 0/10 (0%) | ||
| Peritoneal cavity, hemorrhage | 0/9 (0%) | 1/10 (10%) | ||
| Stomach, pain | 1/9 (11.1%) | 0/10 (0%) | ||
| Teeth | 1/9 (11.1%) | 0/10 (0%) | ||
| Upper GI, hemorrhage NOS | 0/9 (0%) | 1/10 (10%) | ||
| Varices (rectal), hemorrhage | 1/9 (11.1%) | 1/10 (10%) | ||
| Vomiting | 1/9 (11.1%) | 0/10 (0%) | ||
| General disorders | ||||
| Chest/thoracic pain NOS | 1/9 (11.1%) | 1/10 (10%) | ||
| Edema limb | 2/9 (22.2%) | 3/10 (30%) | ||
| Edema trunk/genital | 0/9 (0%) | 1/10 (10%) | ||
| Extremity-lower (gait/walking) | 1/9 (11.1%) | 0/10 (0%) | ||
| Fatigue | 4/9 (44.4%) | 3/10 (30%) | ||
| Fever w/o neutropenia | 0/9 (0%) | 2/10 (20%) | ||
| Pain-other | 2/9 (22.2%) | 3/10 (30%) | ||
| Hepatobiliary disorders | ||||
| Liver, hemorrhage | 2/9 (22.2%) | 0/10 (0%) | ||
| Liver, pain | 1/9 (11.1%) | 0/10 (0%) | ||
| Immune system disorders | ||||
| Allergic reaction | 1/9 (11.1%) | 0/10 (0%) | ||
| Infections and infestations | ||||
| Infection w/ gr3-4 neut, urinary tract | 1/9 (11.1%) | 0/10 (0%) | ||
| Viral hepatitis | 1/9 (11.1%) | 1/10 (10%) | ||
| Investigations | ||||
| Alkaline phosphatase | 3/9 (33.3%) | 5/10 (50%) | ||
| ALT, SGPT | 7/9 (77.8%) | 5/10 (50%) | ||
| AST, SGOT | 8/9 (88.9%) | 8/10 (80%) | ||
| Bilirubin | 5/9 (55.6%) | 4/10 (40%) | ||
| Coagulation-other | 3/9 (33.3%) | 3/10 (30%) | ||
| Creatinine | 1/9 (11.1%) | 0/10 (0%) | ||
| INR | 5/9 (55.6%) | 5/10 (50%) | ||
| Leukocytes | 3/9 (33.3%) | 1/10 (10%) | ||
| Lymphopenia | 1/9 (11.1%) | 0/10 (0%) | ||
| Metabolic/Laboratory-other | 2/9 (22.2%) | 3/10 (30%) | ||
| Neutrophils | 3/9 (33.3%) | 0/10 (0%) | ||
| Platelets | 7/9 (77.8%) | 4/10 (40%) | ||
| PTT | 1/9 (11.1%) | 0/10 (0%) | ||
| Weight gain | 1/9 (11.1%) | 0/10 (0%) | ||
| Weight loss | 3/9 (33.3%) | 2/10 (20%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 4/9 (44.4%) | 2/10 (20%) | ||
| Bicarbonate | 1/9 (11.1%) | 0/10 (0%) | ||
| Hyperglycemia | 4/9 (44.4%) | 1/10 (10%) | ||
| Hypoalbuminemia | 3/9 (33.3%) | 2/10 (20%) | ||
| Hypocalcemia | 1/9 (11.1%) | 0/10 (0%) | ||
| Hypoglycemia | 1/9 (11.1%) | 1/10 (10%) | ||
| Hypomagnesemia | 1/9 (11.1%) | 0/10 (0%) | ||
| Hyponatremia | 2/9 (22.2%) | 1/10 (10%) | ||
| Hypophosphatemia | 1/9 (11.1%) | 0/10 (0%) | ||
| Pancreatic glucose intolerance | 0/9 (0%) | 1/10 (10%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back, pain | 1/9 (11.1%) | 2/10 (20%) | ||
| Extremity-limb, pain | 1/9 (11.1%) | 1/10 (10%) | ||
| Joint, pain | 2/9 (22.2%) | 2/10 (20%) | ||
| Musculoskeletal/soft tissue-other | 1/9 (11.1%) | 0/10 (0%) | ||
| Nonneuropathic generalized weakness | 0/9 (0%) | 1/10 (10%) | ||
| Nervous system disorders | ||||
| Cognitive disturbance | 1/9 (11.1%) | 0/10 (0%) | ||
| Head/headache | 0/9 (0%) | 2/10 (20%) | ||
| Neuropathy-motor | 1/9 (11.1%) | 0/10 (0%) | ||
| Neuropathy-sensory | 0/9 (0%) | 2/10 (20%) | ||
| Psychiatric disorders | ||||
| Agitation | 0/9 (0%) | 1/10 (10%) | ||
| Anxiety | 1/9 (11.1%) | 2/10 (20%) | ||
| Confusion | 1/9 (11.1%) | 1/10 (10%) | ||
| Insomnia | 1/9 (11.1%) | 2/10 (20%) | ||
| Renal and urinary disorders | ||||
| Incontinence urinary | 1/9 (11.1%) | 0/10 (0%) | ||
| Renal/GU-other | 1/9 (11.1%) | 0/10 (0%) | ||
| Urethra, pain | 1/9 (11.1%) | 0/10 (0%) | ||
| Urinary retention | 2/9 (22.2%) | 0/10 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Atelectasis | 0/9 (0%) | 1/10 (10%) | ||
| Cough | 1/9 (11.1%) | 3/10 (30%) | ||
| Dyspnea | 0/9 (0%) | 1/10 (10%) | ||
| Hypoxia | 1/9 (11.1%) | 0/10 (0%) | ||
| Nasal cavity/paranasal sinus reaction | 0/9 (0%) | 3/10 (30%) | ||
| Pleural effusion (non-malignant) | 0/9 (0%) | 1/10 (10%) | ||
| Pneumonitis/pulmonary infiltrates | 1/9 (11.1%) | 0/10 (0%) | ||
| Pneumothorax | 1/9 (11.1%) | 1/10 (10%) | ||
| Pulmonary/Upper Respiratory-other | 0/9 (0%) | 2/10 (20%) | ||
| Voice changes/dysarthria | 1/9 (11.1%) | 1/10 (10%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Nail changes | 0/9 (0%) | 1/10 (10%) | ||
| Petechiae | 0/9 (0%) | 1/10 (10%) | ||
| Pruritus/itching | 2/9 (22.2%) | 1/10 (10%) | ||
| Rash/desquamation | 1/9 (11.1%) | 0/10 (0%) | ||
| Rash: acne/acneiform | 1/9 (11.1%) | 0/10 (0%) | ||
| Skin-other | 0/9 (0%) | 2/10 (20%) | ||
| Sweating | 0/9 (0%) | 1/10 (10%) | ||
| Vascular disorders | ||||
| Hypertension | 3/9 (33.3%) | 2/10 (20%) | ||
| Hypotension | 0/9 (0%) | 1/10 (10%) | ||
| Thrombosis/thrombus/embolism | 0/9 (0%) | 1/10 (10%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Andrea Bullock MD, MPH |
|---|---|
| Organization | Beth Israel Deasoness Medical Center |
| Phone | |
| abullock@bidmc.harvard.edu |
- 08-256
- K23CA139005
- IST000508