Vorinostat and Rituximab in Treating Patients With Indolent Non-Hodgkin Lymphoma
Study Details
Study Description
Brief Summary
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving vorinostat together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving vorinostat together with rituximab and to see how well it works in treating patients with indolent non-Hodgkin lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
-
To evaluate the anti-tumor activity of vorinostat and rituximab, in terms of objective response rate, time to progression, and survival, in patients with indolent non-Hodgkin lymphoma.
-
To assess the toxicity profile of this regimen in these patients.
OUTLINE: Patients receive oral vorinostat twice daily on days 1-14 and rituximab IV on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vorinostat and Rituximab Vorinostat by mouth two times (2X) per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks . |
Biological: rituximab
Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks.
Drug: vorinostat
200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle.
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate (Complete and Partial Response) [After every 3 cycles, up to 1 year after the start of treatment]
Response was assessed according to the 2007 Cheson criteria using CT scans or PET: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), >=50% decrease in the Sum of the Product of Diameters (SPD) of up to 6 largest dominant masses and no increase in the size of other nodes; Overall Response (OR) = CR + PR.
Secondary Outcome Measures
- Progression-free Survival [Until disease progress\relapse, up to 1 year after the start of treatment]
Progression\Relapse is defined using the 2007 Cheson criteria, as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy; or at least a 50% increase for nadir in the SPD of any previously involved nodes; or at least a 50% increase in the longest diameter of any singe previously identified node more than 1 cm in its short axis. Estimated using the product-limit method of Kaplan and Meier.
- Number of Participants With Grade 3 and 4 Toxicities [3 weeks after the stop of treatment]
Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 3.0.
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients must have histologically or cytologically confirmed indolent Non-Hodgkin's Lymphoma; included in this category are newly diagnosed or relapsed/refractory follicular center lymphomas grade I, II, III, relapsed/refractory marginal zone B-cell lymphoma (nodal and extranodal), relapsed/refractory mantle cell lymphoma
Patients must have measurable disease by computed tomography (CT) scan; positron emission tomography (PET) scan evaluations are desirable but not mandatory, so that patients with negative PET scans but measurable disease by CT are eligible
Patients may have had up to four prior chemotherapeutic regimens; steroids alone and local radiation do not count as regimens (radiotherapy must have been completed at least 14 days prior to starting vorinostat); Rituxan alone does not count as a regimen; however, Bexxar or Zevalin do; for treated patients, the most recent therapy must have failed to induce a complete response (i.e., there is persistent disease by CT or PET), or there must be disease progression or recurrence after the most recent therapy
Patients may be enrolled who relapse after autologous stem cell transplant if they are at least three months after transplant, and after allogeneic transplant if they are at least six month post transplant; to be eligible after either type of transplant, patients should have no active related infections (i.e., fungal or viral); in the case of allogeneic transplant relapse, there should be no active acute graft versus host disease (GvHD) of any grade, and no chronic graft versus host disease other than mild skin, oral, or ocular GvHD not requiring systemic immunosuppression
Life expectancy of greater than 3 months
Eastern Cooperative Oncology Group (ECOG) performance status 2 (Karnofsky >= 60%)
Absolute neutrophil count >= 1,000/mcL
Platelets >= 100,000/mcL
Total bilirubin within normal institutional limits; patients with elevation of unconjugated bilirubin alone, as in Gilbert's disease, are eligible
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
Creatinine up to and including 2 mg/dl
Pre-menopausal women must have a negative serum pregnancy test prior to entry on this study; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Patients who have had chemotherapy within 4 weeks, or radiotherapy within 2 weeks or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded; this does not include use of steroids, which may continue until two days prior to enrollment; low dose chlorambucil should be stopped two weeks prior to beginning vorinostat; valproic acid should be stopped at least two weeks prior to enrollment; nitrosoureas and mitomycin should be stopped 6 weeks prior to enrollment
Patients may not be receiving any other investigational agents
Patients with known brain metastases are excluded from this clinical trial unless the metastases are controlled after therapy and have not been treated with steroids within the past two months
History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat
There must be no plans for the patient to receive concurrent hormonal, biological, or radiation therapy
Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued if mother is treated with vorinostat
Human immunodeficiency virus (HIV)-positive patients receiving combination antiretroviral therapy are ineligible; in addition, HIV patients not receiving combination antiretroviral therapy are also ineligible
Patients with other active malignancies are ineligible for this study
Patients with preexisting or previous coagulation issues are not excluded from study as long as 1) previous pulmonary embolism or deep vein thrombosis have been adequately treated or 2) if they are actively receiving Coumadin or lovenox for anticoagulation; patients who are already on coumadin or lovenox do not need to take additional 40 mg subcutaneous injections daily
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tower Cancer Research Foundation | Beverly Hills | California | United States | 90211 |
| 2 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010-3000 |
| 3 | City of Hope Medical Group | Pasadena | California | United States | 91105 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Robert Chen, MD, City of Hope Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.- 07195
- P30CA033572
- CDR0000600989
- NCI-2010-00531
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Vorinostat and Rituximab |
|---|---|
| Arm/Group Description | Vorinostat by mouth two times (2X) per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks . rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks. vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle. |
| Period Title: Overall Study | |
| STARTED | 30 |
| COMPLETED | 28 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Vorinostat and Rituximab |
|---|---|
| Arm/Group Description | Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks . rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks. vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle. |
| Overall Participants | 28 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
62
|
| Sex: Female, Male (Count of Participants) | |
| Female |
13
46.4%
|
| Male |
15
53.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
6
21.4%
|
| Not Hispanic or Latino |
21
75%
|
| Unknown or Not Reported |
1
3.6%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
3
10.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
25
89.3%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
28
100%
|
Outcome Measures
| Title | Overall Response Rate (Complete and Partial Response) |
|---|---|
| Description | Response was assessed according to the 2007 Cheson criteria using CT scans or PET: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), >=50% decrease in the Sum of the Product of Diameters (SPD) of up to 6 largest dominant masses and no increase in the size of other nodes; Overall Response (OR) = CR + PR. |
| Time Frame | After every 3 cycles, up to 1 year after the start of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vorinostat and Rituximab |
|---|---|
| Arm/Group Description | Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks . rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks. vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle. |
| Measure Participants | 28 |
| Number [percentage of participants] |
46
164.3%
|
| Title | Progression-free Survival |
|---|---|
| Description | Progression\Relapse is defined using the 2007 Cheson criteria, as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy; or at least a 50% increase for nadir in the SPD of any previously involved nodes; or at least a 50% increase in the longest diameter of any singe previously identified node more than 1 cm in its short axis. Estimated using the product-limit method of Kaplan and Meier. |
| Time Frame | Until disease progress\relapse, up to 1 year after the start of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vorinostat and Rituximab |
|---|---|
| Arm/Group Description | Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks . rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks. vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle. |
| Measure Participants | 28 |
| Median (95% Confidence Interval) [Months] |
29.2
|
| Title | Number of Participants With Grade 3 and 4 Toxicities |
|---|---|
| Description | Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 3.0. |
| Time Frame | 3 weeks after the stop of treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Vorinostat and Rituximab |
|---|---|
| Arm/Group Description | Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks . rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks. vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle. |
| Measure Participants | 28 |
| Neutrophil count decreased |
3
10.7%
|
| Platelet count decreased |
5
17.9%
|
| Hemoglobin decreased |
1
3.6%
|
| Lymphocyte count decreased |
7
25%
|
| Hypotension |
2
7.1%
|
| Chills |
1
3.6%
|
| Fatigue |
9
32.1%
|
| Dehydration |
3
10.7%
|
| Diarrhea |
1
3.6%
|
| Kidney infection |
1
3.6%
|
| Pneumonia |
2
7.1%
|
| Sepsis |
1
3.6%
|
| Urinary tract infection |
1
3.6%
|
| Localized edema |
1
3.6%
|
| Alanine aminotransferase increased |
1
3.6%
|
| Aspartate aminotransferase increased |
1
3.6%
|
| Blood glucose increased |
3
10.7%
|
| Serum phosphate decreased |
3
10.7%
|
| Serum potassium decreased |
2
7.1%
|
| Muscle weakness |
1
3.6%
|
| Syncope |
1
3.6%
|
| Hypoxia |
1
3.6%
|
| Pneumonitis |
1
3.6%
|
| Thrombosis |
4
14.3%
|
| Vascular access complication |
1
3.6%
|
Adverse Events
| Time Frame | Adverse events were collected over a period of seven years. | |
|---|---|---|
| Adverse Event Reporting Description | "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment. | |
| Arm/Group Title | Vorinostat and Rituximab | |
| Arm/Group Description | Vorinostat by mouth 2X per day for two weeks followed by one week of rest. Rituximab intravenously once every three weeks . rituximab: Rituximab will be administered at a dose of 375 mg/m2 on day 1 of every cycle, every 3 weeks. vorinostat: 200 mg twice daily, orally for 14 days followed by a seven day break on a 21 day cycle. | |
All Cause Mortality |
||
| Vorinostat and Rituximab | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/30 (0%) | |
Serious Adverse Events |
||
| Vorinostat and Rituximab | ||
| Affected / at Risk (%) | # Events | |
| Total | 13/30 (43.3%) | |
| Gastrointestinal disorders | ||
| Gastrointestinal disorder | 1/30 (3.3%) | 1 |
| Lower gastrointestinal hemorrhage | 1/30 (3.3%) | 1 |
| Infections and infestations | ||
| Kidney infection | 1/30 (3.3%) | 1 |
| Pneumonia | 1/30 (3.3%) | 1 |
| Sepsis | 1/30 (3.3%) | 1 |
| Injury, poisoning and procedural complications | ||
| Vascular access complication | 1/30 (3.3%) | 1 |
| Metabolism and nutrition disorders | ||
| Dehydration | 1/30 (3.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Chest wall pain | 1/30 (3.3%) | 1 |
| Nervous system disorders | ||
| Ischemia cerebrovascular | 1/30 (3.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Pneumothorax | 1/30 (3.3%) | 1 |
| Vascular disorders | ||
| Hypotension | 1/30 (3.3%) | 1 |
| Thrombosis | 4/30 (13.3%) | 5 |
Other (Not Including Serious) Adverse Events |
||
| Vorinostat and Rituximab | ||
| Affected / at Risk (%) | # Events | |
| Total | 30/30 (100%) | |
| Blood and lymphatic system disorders | ||
| Hemoglobin decreased | 22/30 (73.3%) | 152 |
| Hemolysis | 1/30 (3.3%) | 1 |
| Lymph node pain | 1/30 (3.3%) | 2 |
| Cardiac disorders | ||
| Atrial fibrillation | 1/30 (3.3%) | 8 |
| Cardiac disorder | 1/30 (3.3%) | 1 |
| Palpitations | 2/30 (6.7%) | 5 |
| Sinus bradycardia | 2/30 (6.7%) | 2 |
| Sinus tachycardia | 2/30 (6.7%) | 2 |
| Ear and labyrinth disorders | ||
| Ear pain | 1/30 (3.3%) | 2 |
| External ear pain | 1/30 (3.3%) | 2 |
| Tinnitus | 1/30 (3.3%) | 1 |
| Eye disorders | ||
| Dry eye syndrome | 4/30 (13.3%) | 6 |
| Eye disorder | 2/30 (6.7%) | 8 |
| Vision blurred | 1/30 (3.3%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal distension | 6/30 (20%) | 13 |
| Abdominal pain | 13/30 (43.3%) | 48 |
| Anal hemorrhage | 1/30 (3.3%) | 1 |
| Constipation | 16/30 (53.3%) | 50 |
| Diarrhea | 24/30 (80%) | 304 |
| Dry mouth | 11/30 (36.7%) | 27 |
| Dyspepsia | 8/30 (26.7%) | 19 |
| Dysphagia | 3/30 (10%) | 3 |
| Ear, nose and throat examination abnormal | 2/30 (6.7%) | 2 |
| Flatulence | 10/30 (33.3%) | 14 |
| Gastritis | 1/30 (3.3%) | 1 |
| Gastrointestinal disorder | 2/30 (6.7%) | 3 |
| Hemorrhoids | 1/30 (3.3%) | 1 |
| Lower gastrointestinal hemorrhage | 1/30 (3.3%) | 1 |
| Mucositis oral | 2/30 (6.7%) | 2 |
| Nausea | 22/30 (73.3%) | 174 |
| Oral hemorrhage | 1/30 (3.3%) | 2 |
| Oral pain | 2/30 (6.7%) | 12 |
| Stomach pain | 2/30 (6.7%) | 3 |
| Toothache | 1/30 (3.3%) | 1 |
| Vomiting | 10/30 (33.3%) | 33 |
| General disorders | ||
| Chest pain | 8/30 (26.7%) | 9 |
| Chills | 16/30 (53.3%) | 67 |
| Edema limbs | 11/30 (36.7%) | 26 |
| Facial pain | 2/30 (6.7%) | 3 |
| Fatigue | 26/30 (86.7%) | 279 |
| Fever | 14/30 (46.7%) | 26 |
| Flu-like symptoms | 2/30 (6.7%) | 2 |
| Injection site reaction | 4/30 (13.3%) | 4 |
| Localized edema | 4/30 (13.3%) | 14 |
| Pain | 6/30 (20%) | 8 |
| Immune system disorders | ||
| Hypersensitivity | 8/30 (26.7%) | 10 |
| Infections and infestations | ||
| Eye infection | 2/30 (6.7%) | 2 |
| Infection | 2/30 (6.7%) | 2 |
| Lip infection | 1/30 (3.3%) | 1 |
| Nail infection | 1/30 (3.3%) | 1 |
| Peripheral nerve infection | 1/30 (3.3%) | 1 |
| Pneumonia | 4/30 (13.3%) | 4 |
| Rhinitis infective | 1/30 (3.3%) | 1 |
| Sinusitis | 5/30 (16.7%) | 17 |
| Tooth infection | 2/30 (6.7%) | 2 |
| Upper respiratory infection | 8/30 (26.7%) | 9 |
| Urinary tract infection | 6/30 (20%) | 12 |
| Wound infection | 1/30 (3.3%) | 1 |
| Injury, poisoning and procedural complications | ||
| Bruising | 10/30 (33.3%) | 13 |
| Vascular access complication | 1/30 (3.3%) | 2 |
| Investigations | ||
| Activated partial thromboplastin time prolonged | 6/30 (20%) | 13 |
| Alanine aminotransferase increased | 11/30 (36.7%) | 20 |
| Alkaline phosphatase increased | 10/30 (33.3%) | 37 |
| Aspartate aminotransferase increased | 18/30 (60%) | 54 |
| Bilirubin increased | 1/30 (3.3%) | 9 |
| Creatinine increased | 18/30 (60%) | 128 |
| Leukocyte count decreased | 16/30 (53.3%) | 143 |
| Lymphocyte count decreased | 11/30 (36.7%) | 49 |
| Neutrophil count decreased | 15/30 (50%) | 75 |
| Platelet count decreased | 20/30 (66.7%) | 137 |
| Weight loss | 3/30 (10%) | 7 |
| Metabolism and nutrition disorders | ||
| Anorexia | 19/30 (63.3%) | 71 |
| Blood bicarbonate decreased | 2/30 (6.7%) | 8 |
| Blood glucose increased | 15/30 (50%) | 55 |
| Blood uric acid increased | 1/30 (3.3%) | 1 |
| Dehydration | 6/30 (20%) | 9 |
| Serum albumin decreased | 15/30 (50%) | 45 |
| Serum calcium decreased | 16/30 (53.3%) | 51 |
| Serum calcium increased | 3/30 (10%) | 11 |
| Serum glucose decreased | 16/30 (53.3%) | 90 |
| Serum magnesium decreased | 2/30 (6.7%) | 2 |
| Serum magnesium increased | 5/30 (16.7%) | 10 |
| Serum phosphate decreased | 9/30 (30%) | 16 |
| Serum potassium decreased | 4/30 (13.3%) | 14 |
| Serum potassium increased | 9/30 (30%) | 22 |
| Serum sodium decreased | 15/30 (50%) | 63 |
| Serum sodium increased | 2/30 (6.7%) | 4 |
| Serum triglycerides increased | 1/30 (3.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Back pain | 8/30 (26.7%) | 17 |
| Bone pain | 3/30 (10%) | 17 |
| Chest wall pain | 5/30 (16.7%) | 5 |
| Joint pain | 8/30 (26.7%) | 17 |
| Muscle weakness | 12/30 (40%) | 16 |
| Muscle weakness lower limb | 4/30 (13.3%) | 6 |
| Muscle weakness upper limb | 2/30 (6.7%) | 4 |
| Musculoskeletal disorder | 3/30 (10%) | 9 |
| Myalgia | 6/30 (20%) | 11 |
| Neck pain | 3/30 (10%) | 4 |
| Pain in extremity | 11/30 (36.7%) | 66 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Tumor pain | 1/30 (3.3%) | 1 |
| Nervous system disorders | ||
| Depressed level of consciousness | 1/30 (3.3%) | 1 |
| Dizziness | 12/30 (40%) | 41 |
| Extrapyramidal disorder | 1/30 (3.3%) | 1 |
| Headache | 14/30 (46.7%) | 58 |
| Memory impairment | 4/30 (13.3%) | 8 |
| Neuralgia | 1/30 (3.3%) | 1 |
| Neurological disorder NOS | 2/30 (6.7%) | 2 |
| Peripheral motor neuropathy | 2/30 (6.7%) | 7 |
| Peripheral sensory neuropathy | 7/30 (23.3%) | 14 |
| Speech disorder | 2/30 (6.7%) | 2 |
| Syncope | 1/30 (3.3%) | 1 |
| Taste alteration | 10/30 (33.3%) | 47 |
| Tremor | 3/30 (10%) | 9 |
| Psychiatric disorders | ||
| Agitation | 3/30 (10%) | 7 |
| Anxiety | 5/30 (16.7%) | 24 |
| Confusion | 2/30 (6.7%) | 2 |
| Depression | 5/30 (16.7%) | 8 |
| Insomnia | 9/30 (30%) | 28 |
| Psychosis | 1/30 (3.3%) | 1 |
| Renal and urinary disorders | ||
| Hemorrhage urinary tract | 2/30 (6.7%) | 5 |
| Protein urine positive | 1/30 (3.3%) | 2 |
| Urethral pain | 1/30 (3.3%) | 1 |
| Urinary incontinence | 2/30 (6.7%) | 7 |
| Urogenital disorder | 2/30 (6.7%) | 2 |
| Reproductive system and breast disorders | ||
| Breast pain | 1/30 (3.3%) | 1 |
| Pelvic pain | 1/30 (3.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Allergic rhinitis | 12/30 (40%) | 23 |
| Atelectasis | 3/30 (10%) | 3 |
| Cough | 15/30 (50%) | 106 |
| Dyspnea | 12/30 (40%) | 59 |
| Hemorrhage nasal | 4/30 (13.3%) | 7 |
| Hypoxia | 1/30 (3.3%) | 1 |
| Laryngeal pain | 2/30 (6.7%) | 2 |
| Pharyngolaryngeal pain | 9/30 (30%) | 19 |
| Pleural effusion | 3/30 (10%) | 3 |
| Pneumonitis | 1/30 (3.3%) | 1 |
| Respiratory disorder | 1/30 (3.3%) | 1 |
| Respiratory tract hemorrhage | 1/30 (3.3%) | 1 |
| Voice alteration | 2/30 (6.7%) | 2 |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 10/30 (33.3%) | 64 |
| Dry skin | 5/30 (16.7%) | 6 |
| Nail disorder | 2/30 (6.7%) | 17 |
| Pruritus | 4/30 (13.3%) | 4 |
| Rash desquamating | 7/30 (23.3%) | 15 |
| Sweating | 9/30 (30%) | 13 |
| Vascular disorders | ||
| Flushing | 2/30 (6.7%) | 2 |
| Hemorrhage | 1/30 (3.3%) | 1 |
| Hot flashes | 2/30 (6.7%) | 3 |
| Hypertension | 8/30 (26.7%) | 25 |
| Hypotension | 4/30 (13.3%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Paul Frankel, Ph.D. |
|---|---|
| Organization | City of Hope |
| Phone | 626-812-5265 |
| pfrankel@coh.org |
- 07195
- P30CA033572
- CDR0000600989
- NCI-2010-00531