FOLFIRINOX + RT for Pancreatic Cancer
Study Details
Study Description
Brief Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of a therapy to learn whether the therapy works in treating a specific cancer. "Investigational" means that the therapy is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if therapy is effective for treating different types of cancer. Proton beam radiation therapy is an FDA (U.S. Food and Drug Administration) approved radiation delivery system.
Proton beam radiation therapy is known to spare surrounding normal tissues from radiation as it delivers less radiation beyond the area of the target tissues. This may reduce side effects that patients would normally experience with standard (photon) radiation therapy, which tends to include more normal tissue along with tumor target tissue.
Researchers in the laboratory have discovered that there are pathways inside the cells that can lead to growth and survival of the tumor. The chemotherapy drugs FOLFIRINOX and capecitabine are targeted towards blocking the pathways that allow cancer cells to divide, and may result in the tumor shrinking in size.
In this research study, the investigators are looking to determine if proton beam radiation in combination with FOLFIRINOX and capecitabine is effective in controlling the growth of your cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
For weeks 1-8, you will only be receiving FOLFIRINOX via IV infusion. The treatment plan will begin with four cycles (8 weeks) of FOLFIRINOX. Each cycle is 14 days long. You will receive FOLFIRINOX therapy on days 1, 2 and 3 of each of the four cycles. The FOLFIRINOX treatment is broken up into three different drugs. 5-FU will be administered over two hours on day one of each cycle, and then continuously with a pump for days 2 and 3. Oxaliplatin will be delivered by intravenous (infusion) over 120 minutes. Irinotecan will be given by IV for 90 minutes. All parts of this treatment will be received as an outpatient.
If after 4 cycles of FOLFIRINOX therapy, your tumor has not spread, you will receive a further 4 cycles of FOLFIRINOX. If after 8 total cycles of FOLFIRINOX your cancer is clearly resectable, you will proceed to phase 2 of treatment with capecitabine and radiation therapy.
You will take tablets of capecitabine by mouth for a total of 10 days (Monday through Friday) during the two weeks after your FOLFIRINOX treatment.
You will be given a drug diary for capecitabine which contains instructions on how to take the drug.
Short course radiation: You will receive proton radiation treatment for five days (Monday through Friday) after your FOLFIRINOX treatment, during the time of your capecitabine treatment, or photon radiation for ten days (Monday through Friday for two weeks). You will also be assessed at least once during this treatment course for any side effects you may be experiencing.
You will receive study radiation treatment as an outpatient at the Francis H. Burr Proton Center or the Clark Center for Radiation Oncology at the Massachusetts General Hospital Surgery is expected to occur approximately one to four weeks after completion of capecitabine therapy.
After your surgery, you may receive additional chemotherapy at the discretion of your treating physician and be followed as per standard of care.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Arm All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. |
Drug: FOLFIRINOX
Up to Eight-14 day cycles
Other Names:
Drug: Capecitabine
Orally, for 10 days
Radiation: Short Course Radiation
Five or ten days
Procedure: Surgery
1-4 weeks after completion of capecitabine therapy
|
Outcome Measures
Primary Outcome Measures
- Rate of R0 Resection [Post-surgery (about 4 months post baseline)]
The rate of R0 resection of patients with borderline-resectable adenocarcinoma of the head of the pancreas, along with borderline-resectable and resectable adenocarcinoma of the body and tail of the pancreas. R0 resection means that following surgery, no cancer cells are seen microscopically at the resection margin.
Secondary Outcome Measures
- Median Progression-Free Survival [From the start of treatment until death or disease progression, median duration of follow-up of 14.7 months]
The median progression free survival as measured from the start of treatment until the time of disease progression or death, whichever occurs first. Disease status was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Disease progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesion, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Median Overall Survival [From the start of treatment until the time of death, median duration of follow-up of 37.7 months]
Median overall survival, as measured from the start of treatment until the time of death.
- Preoperative Toxicity of Grade 3 or Worse Related to FOLFIRINOX and Chemoradiation [From the start of treatment until the end of chemoradiation, about 4 months]
Frequency of grade 3 or greater adverse events deemed related to FOLFIRINOX+short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
- The Proportion of Participants With Surgery Related Adverse Events [At the time of surgery, 30 days post-surgery]
The number of participants with surgery related any grade adverse events following pancreaticoduodenectomy or distal pancreatectomy after receiving preoperative FOLFIRINOX and preoperative short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
- 30 Day Post-operative Mortality Rate [30 days post surgery (about 6 months from baseline)]
The number of participants that died within 30 days after undergoing pancreaticoduodenectomy or distal pancreatectomy.
- Rate of Pathologic Downstaging [Baseline, Post surgery]
To determine the rate of pathologic down-staging among participants that underwent pancreaticoduodenectomy or distal pancreatectomy. The pathologic downstaging rate is the proportion of patients with the primary tumor and nodes downstaged based on final pathology of the surgical specimen.
- Local Control Rates [From the start of treatment until the end of treatment with FOLFIRINOX, or until disease progression (median duration of follow-up of approximately 14 months)]
The number of participants that achieved local control. Local control was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Local Failure is defined as progression of the primary tumor, or to the reappearance of tumor at the primary site.
- Correlation of Mutational Analysis Biomarkers [2 years]
To correlate mutational analysis biomarkers (SNaPSHOT assay) with response to treatment
- Quality of Life, Symptom Burden, and Mood [2 years]
Patient-reported outcomes: We will use descriptive statistics to describe Quality of Life (QOL) (EORTC QLQ-C30), symptom burden (ESAS-r) and mood (HADS) for the entire study cohort.
- Utilization of Health Services (Emergency Room, Hospital and Intensive Care Unit) [2 years]
Summary of the number of hospitalizations, intensive care unit (ICU) stays, emergency department (ED) stays, and palliative care use for the study population.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Cytologic or histologic proof pancreatic ductal carcinoma
-
Borderline resectable
-
Life expectancy of at least 3 months
-
ECOG Performance Status ≤ 1
-
Adequate organ and bone marrow function
-
No treatment of other invasive cancers within the last 5 years with greater than 5% risk of recurrence at the time of eligibility screening. Carcinoma in-situ and basal cell carcinoma/squamous cell carcinoma of the skin are allowed
-
4 weeks since major surgery, excluding laparoscopy
Exclusion Criteria:
-
Evidence of metastatic disease
-
Pregnant or breastfeeding
-
Other serious uncontrolled medical conditions
-
Prior chemotherapy, targeted/biologic therapy or radiation for treatment of the pancreatic tumor
-
Prior systemic fluoropyrimidine therapy
-
History of uncontrolled seizures, central nervous system disorders or psychiatric disability
-
Individuals on cimetidine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Theodore S Hong, M.D., Massachusetts General Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- 11-328
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | FOLFIRINOX + Radiation |
|---|---|
| Arm/Group Description | All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy |
| Period Title: Overall Study | |
| STARTED | 48 |
| COMPLETED | 48 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | FOLFIRINOX + Radiation |
|---|---|
| Arm/Group Description | All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy |
| Overall Participants | 48 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
62
|
| Sex: Female, Male (Count of Participants) | |
| Female |
21
43.8%
|
| Male |
27
56.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
2.1%
|
| Not Hispanic or Latino |
46
95.8%
|
| Unknown or Not Reported |
1
2.1%
|
| Region of Enrollment (Count of Participants) | |
| United States |
48
100%
|
| CA19-9 Level (Count of Participants) | |
| <35 U/ml (Normal) |
12
25%
|
| ≥35 U/ml (elevated) |
36
75%
|
| CEA Level (Count of Participants) | |
| <3.4 ng/ml (normal) |
23
47.9%
|
| ≥3.4 ng/ml (elevated) |
25
52.1%
|
| Pancreatic Tumor Site (Count of Participants) | |
| Head |
35
72.9%
|
| Body |
11
22.9%
|
| Tail |
2
4.2%
|
| Tumor Size (Centimeters (cm)) [Median (Full Range) ] | |
| Median (Full Range) [Centimeters (cm)] |
3.75
|
| Vessel Involvement (Count of Participants) | |
| Venous |
28
58.3%
|
| Arterial |
7
14.6%
|
| Both |
12
25%
|
| None |
1
2.1%
|
Outcome Measures
| Title | Rate of R0 Resection |
|---|---|
| Description | The rate of R0 resection of patients with borderline-resectable adenocarcinoma of the head of the pancreas, along with borderline-resectable and resectable adenocarcinoma of the body and tail of the pancreas. R0 resection means that following surgery, no cancer cells are seen microscopically at the resection margin. |
| Time Frame | Post-surgery (about 4 months post baseline) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | All Eligible - FOLFIRINOX + Radiation | Resected Participants - FOLFIRINOX + Radiation |
|---|---|---|
| Arm/Group Description | The overall study population All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy | The participants that were resected. All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy |
| Measure Participants | 48 | 32 |
| Count of Participants [Participants] |
31
64.6%
|
31
NaN
|
| Title | Median Progression-Free Survival |
|---|---|
| Description | The median progression free survival as measured from the start of treatment until the time of disease progression or death, whichever occurs first. Disease status was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Disease progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesion, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Time Frame | From the start of treatment until death or disease progression, median duration of follow-up of 14.7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FOLFIRINOX + Radiation |
|---|---|
| Arm/Group Description | All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy |
| Measure Participants | 48 |
| Median (95% Confidence Interval) [Months] |
14.7
|
| Title | Median Overall Survival |
|---|---|
| Description | Median overall survival, as measured from the start of treatment until the time of death. |
| Time Frame | From the start of treatment until the time of death, median duration of follow-up of 37.7 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FOLFIRINOX + Radiation |
|---|---|
| Arm/Group Description | All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy |
| Measure Participants | 48 |
| Median (95% Confidence Interval) [Months] |
37.7
|
| Title | Preoperative Toxicity of Grade 3 or Worse Related to FOLFIRINOX and Chemoradiation |
|---|---|
| Description | Frequency of grade 3 or greater adverse events deemed related to FOLFIRINOX+short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). |
| Time Frame | From the start of treatment until the end of chemoradiation, about 4 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FOLFIRINOX + Radiation |
|---|---|
| Arm/Group Description | All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy |
| Measure Participants | 48 |
| Diarrhea |
5
10.4%
|
| Neutropenia |
2
4.2%
|
| Febrile neutropenia |
1
2.1%
|
| Lymphopenia |
1
2.1%
|
| Thrombocytopenia |
1
2.1%
|
| Anemia |
1
2.1%
|
| Elevated alkaline phosphatase |
1
2.1%
|
| Elevated bilirubin |
1
2.1%
|
| Elevated AST/ALT |
1
2.1%
|
| Peripheral neuropathy |
2
4.2%
|
| Abdominal pain |
1
2.1%
|
| Constipation |
1
2.1%
|
| Title | The Proportion of Participants With Surgery Related Adverse Events |
|---|---|
| Description | The number of participants with surgery related any grade adverse events following pancreaticoduodenectomy or distal pancreatectomy after receiving preoperative FOLFIRINOX and preoperative short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). |
| Time Frame | At the time of surgery, 30 days post-surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| The participants that underwent surgery |
| Arm/Group Title | FOLFIRINOX + Radiation |
|---|---|
| Arm/Group Description | All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy |
| Measure Participants | 32 |
| Number (90% Confidence Interval) [proportion of participants] |
0.375
0.8%
|
| Title | 30 Day Post-operative Mortality Rate |
|---|---|
| Description | The number of participants that died within 30 days after undergoing pancreaticoduodenectomy or distal pancreatectomy. |
| Time Frame | 30 days post surgery (about 6 months from baseline) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number of participants that underwent surgery |
| Arm/Group Title | FOLFIRINOX + Radiation |
|---|---|
| Arm/Group Description | All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy |
| Measure Participants | 32 |
| Count of Participants [Participants] |
0
0%
|
| Title | Rate of Pathologic Downstaging |
|---|---|
| Description | To determine the rate of pathologic down-staging among participants that underwent pancreaticoduodenectomy or distal pancreatectomy. The pathologic downstaging rate is the proportion of patients with the primary tumor and nodes downstaged based on final pathology of the surgical specimen. |
| Time Frame | Baseline, Post surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Local Control Rates |
|---|---|
| Description | The number of participants that achieved local control. Local control was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Local Failure is defined as progression of the primary tumor, or to the reappearance of tumor at the primary site. |
| Time Frame | From the start of treatment until the end of treatment with FOLFIRINOX, or until disease progression (median duration of follow-up of approximately 14 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The first 5 participants treated who only received 4 cycles of FOLFIRINOX instead of 8 were not included in the analysis of local control. |
| Arm/Group Title | FOLFIRINOX + Radiation |
|---|---|
| Arm/Group Description | All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy |
| Measure Participants | 43 |
| Count of Participants [Participants] |
32
66.7%
|
| Title | Correlation of Mutational Analysis Biomarkers |
|---|---|
| Description | To correlate mutational analysis biomarkers (SNaPSHOT assay) with response to treatment |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Quality of Life, Symptom Burden, and Mood |
|---|---|
| Description | Patient-reported outcomes: We will use descriptive statistics to describe Quality of Life (QOL) (EORTC QLQ-C30), symptom burden (ESAS-r) and mood (HADS) for the entire study cohort. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Utilization of Health Services (Emergency Room, Hospital and Intensive Care Unit) |
|---|---|
| Description | Summary of the number of hospitalizations, intensive care unit (ICU) stays, emergency department (ED) stays, and palliative care use for the study population. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | From the start of treatment until 30 days after the end of treatment, about 6 months. Treatment is continued until disease progression, intercurrent illness that prevents further treatment, unacceptable adverse events, participant withdrawal, or until the treating investigator decides it is in the participants best interest. | |
|---|---|---|
| Adverse Event Reporting Description | Adverse events were defined as any grade 3 or greater toxicity deemed to be possibly, probably, or definitely related to treatment | |
| Arm/Group Title | FOLFIRINOX + Radiation | |
| Arm/Group Description | All participants will receive the FOLFIRINOX regimen, followed by capecitabine and short course radiation therapy. FOLFIRINOX: Up to Eight-14 day cycles Capecitabine: Orally, for 10 days Short Course Radiation: Five or ten days Surgery: 1-4 weeks after completion of capecitabine therapy | |
All Cause Mortality |
||
| FOLFIRINOX + Radiation | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/48 (4.2%) | |
Serious Adverse Events |
||
| FOLFIRINOX + Radiation | ||
| Affected / at Risk (%) | # Events | |
| Total | 24/48 (50%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 3/48 (6.3%) | 4 |
| Febrile neutropenia | 3/48 (6.3%) | 4 |
| Gastrointestinal disorders | ||
| Abdominal pain | 1/48 (2.1%) | 2 |
| Constipation | 1/48 (2.1%) | 1 |
| Diarrhea | 7/48 (14.6%) | 11 |
| Nausea | 1/48 (2.1%) | 1 |
| General disorders | ||
| Fatigue | 2/48 (4.2%) | 2 |
| Fever | 1/48 (2.1%) | 1 |
| Immune system disorders | ||
| Anaphylaxis | 1/48 (2.1%) | 1 |
| Investigations | ||
| Alanine aminotransferase increased | 2/48 (4.2%) | 4 |
| Alkaline phosphatase increased | 2/48 (4.2%) | 4 |
| Aspartate aminotransferase increased | 3/48 (6.3%) | 4 |
| Blood bilirubin increased | 1/48 (2.1%) | 1 |
| Lymphocyte count decreased | 1/48 (2.1%) | 1 |
| Neutrophil count decreased | 7/48 (14.6%) | 11 |
| Platelet count decreased | 2/48 (4.2%) | 4 |
| Weight loss | 2/48 (4.2%) | 2 |
| White blood cell decreased | 1/48 (2.1%) | 1 |
| Metabolism and nutrition disorders | ||
| Anorexia | 3/48 (6.3%) | 3 |
| Hypokalemia | 1/48 (2.1%) | 1 |
| Nervous system disorders | ||
| Peripheral sensory neuropathy | 2/48 (4.2%) | 2 |
| Vascular disorders | ||
| Hot flashes | 1/48 (2.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| FOLFIRINOX + Radiation | ||
| Affected / at Risk (%) | # Events | |
| Total | 48/48 (100%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 7/48 (14.6%) | 14 |
| Cardiac disorders | ||
| Atrial fibrillation | 4/48 (8.3%) | 6 |
| Cardiac disorders - Other | 9/48 (18.8%) | 17 |
| Palpitations | 6/48 (12.5%) | 9 |
| Sinus tachycardia | 7/48 (14.6%) | 8 |
| Supraventricular tachycardia | 4/48 (8.3%) | 4 |
| Eye disorders | ||
| Blurred vision | 5/48 (10.4%) | 10 |
| Dry eye | 3/48 (6.3%) | 6 |
| Eye disorders - Other | 7/48 (14.6%) | 11 |
| Eye pain | 3/48 (6.3%) | 6 |
| Watering eyes | 3/48 (6.3%) | 5 |
| Gastrointestinal disorders | ||
| Abdominal distension | 18/48 (37.5%) | 38 |
| Abdominal pain | 44/48 (91.7%) | 187 |
| Ascites | 6/48 (12.5%) | 8 |
| Bloating | 16/48 (33.3%) | 33 |
| Constipation | 40/48 (83.3%) | 114 |
| Diarrhea | 43/48 (89.6%) | 201 |
| Dry mouth | 11/48 (22.9%) | 15 |
| Dyspepsia | 12/48 (25%) | 20 |
| Dysphagia | 5/48 (10.4%) | 5 |
| Enterocolitis | 4/48 (8.3%) | 5 |
| Fecal incontinence | 5/48 (10.4%) | 7 |
| Flatulence | 20/48 (41.7%) | 57 |
| Gastroesophageal reflux disease | 17/48 (35.4%) | 28 |
| Gastrointestinal disorders - Other | 26/48 (54.2%) | 54 |
| Gastroparesis | 4/48 (8.3%) | 8 |
| Hemorrhoids | 4/48 (8.3%) | 5 |
| Malabsorption | 13/48 (27.1%) | 20 |
| Mucositis oral | 20/48 (41.7%) | 36 |
| Nausea | 46/48 (95.8%) | 217 |
| Oral pain | 3/48 (6.3%) | 3 |
| Pancreatitis | 3/48 (6.3%) | 3 |
| Rectal pain | 3/48 (6.3%) | 7 |
| Small intestinal obstruction | 3/48 (6.3%) | 3 |
| Toothache | 3/48 (6.3%) | 4 |
| Vomiting | 30/48 (62.5%) | 73 |
| General disorders | ||
| Chills | 16/48 (33.3%) | 21 |
| Edema face | 4/48 (8.3%) | 4 |
| Edema limbs | 18/48 (37.5%) | 51 |
| Facial pain | 3/48 (6.3%) | 4 |
| Fatigue | 48/48 (100%) | 258 |
| Fever | 28/48 (58.3%) | 44 |
| Gait disturbance | 8/48 (16.7%) | 14 |
| General disorders and administration site conditions - Other | 11/48 (22.9%) | 39 |
| Malaise | 7/48 (14.6%) | 13 |
| Non-cardiac chest pain | 5/48 (10.4%) | 9 |
| Pain | 7/48 (14.6%) | 10 |
| Hepatobiliary disorders | ||
| Hepatobiliary disorders - Other | 10/48 (20.8%) | 28 |
| Immune system disorders | ||
| Allergic reaction | 4/48 (8.3%) | 14 |
| Infections and infestations | ||
| Biliary tract infection | 6/48 (12.5%) | 7 |
| Infections and infestations - Other | 10/48 (20.8%) | 16 |
| Mucosal infection | 3/48 (6.3%) | 5 |
| Sepsis | 3/48 (6.3%) | 4 |
| Skin infection | 5/48 (10.4%) | 7 |
| Upper respiratory infection | 8/48 (16.7%) | 11 |
| Urinary tract infection | 7/48 (14.6%) | 16 |
| Injury, poisoning and procedural complications | ||
| Bruising | 10/48 (20.8%) | 15 |
| Fall | 5/48 (10.4%) | 7 |
| Injury, poisoning and procedural complications - Other | 4/48 (8.3%) | 4 |
| Wound complication | 3/48 (6.3%) | 5 |
| Wound dehiscence | 4/48 (8.3%) | 7 |
| Investigations | ||
| Alanine aminotransferase increased | 20/48 (41.7%) | 43 |
| Alkaline phosphatase increased | 6/48 (12.5%) | 12 |
| Aspartate aminotransferase increased | 10/48 (20.8%) | 33 |
| Blood bilirubin increased | 16/48 (33.3%) | 31 |
| Cholesterol high | 4/48 (8.3%) | 4 |
| Neutrophil count decreased | 6/48 (12.5%) | 10 |
| Pancreatic enzymes decreased | 6/48 (12.5%) | 11 |
| Platelet count decreased | 11/48 (22.9%) | 21 |
| Weight gain | 3/48 (6.3%) | 5 |
| Weight loss | 41/48 (85.4%) | 163 |
| Metabolism and nutrition disorders | ||
| Anorexia | 45/48 (93.8%) | 163 |
| Dehydration | 25/48 (52.1%) | 69 |
| Hyperglycemia | 6/48 (12.5%) | 6 |
| Hyperkalemia | 5/48 (10.4%) | 6 |
| Hypokalemia | 20/48 (41.7%) | 92 |
| Hyponatremia | 7/48 (14.6%) | 9 |
| Metabolism and nutrition disorders - Other | 4/48 (8.3%) | 4 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 10/48 (20.8%) | 17 |
| Arthritis | 4/48 (8.3%) | 4 |
| Back pain | 27/48 (56.3%) | 72 |
| Bone pain | 12/48 (25%) | 22 |
| Chest wall pain | 6/48 (12.5%) | 8 |
| Flank pain | 3/48 (6.3%) | 3 |
| Generalized muscle weakness | 9/48 (18.8%) | 28 |
| Muscle weakness lower limb | 3/48 (6.3%) | 4 |
| Musculoskeletal and connective tissue disorder - Other | 8/48 (16.7%) | 12 |
| Myalgia | 9/48 (18.8%) | 18 |
| Neck pain | 3/48 (6.3%) | 3 |
| Pain in extremity | 11/48 (22.9%) | 18 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other | 5/48 (10.4%) | 7 |
| Nervous system disorders | ||
| Cognitive disturbance | 3/48 (6.3%) | 3 |
| Concentration impairment | 3/48 (6.3%) | 4 |
| Dizziness | 24/48 (50%) | 55 |
| Dysarthria | 5/48 (10.4%) | 9 |
| Dysesthesia | 3/48 (6.3%) | 4 |
| Dysgeusia | 25/48 (52.1%) | 36 |
| Headache | 14/48 (29.2%) | 31 |
| Lethargy | 3/48 (6.3%) | 3 |
| Memory impairment | 4/48 (8.3%) | 4 |
| Nervous system disorders - Other | 7/48 (14.6%) | 13 |
| Paresthesia | 9/48 (18.8%) | 14 |
| Peripheral motor neuropathy | 4/48 (8.3%) | 6 |
| Peripheral sensory neuropathy | 46/48 (95.8%) | 243 |
| Somnolence | 3/48 (6.3%) | 3 |
| Spasticity | 8/48 (16.7%) | 19 |
| Tremor | 3/48 (6.3%) | 7 |
| Psychiatric disorders | ||
| Anxiety | 26/48 (54.2%) | 70 |
| Confusion | 5/48 (10.4%) | 5 |
| Depression | 15/48 (31.3%) | 28 |
| Hallucinations | 3/48 (6.3%) | 4 |
| Insomnia | 32/48 (66.7%) | 78 |
| Renal and urinary disorders | ||
| Renal and urinary disorders - Other | 5/48 (10.4%) | 7 |
| Urinary frequency | 10/48 (20.8%) | 20 |
| Urinary incontinence | 4/48 (8.3%) | 8 |
| Urinary tract pain | 3/48 (6.3%) | 5 |
| Urinary urgency | 5/48 (10.4%) | 6 |
| Urine discoloration | 8/48 (16.7%) | 12 |
| Reproductive system and breast disorders | ||
| Reproductive system and breast disorders - Other | 3/48 (6.3%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 15/48 (31.3%) | 34 |
| Dyspnea | 14/48 (29.2%) | 33 |
| Epistaxis | 11/48 (22.9%) | 19 |
| Hiccups | 7/48 (14.6%) | 11 |
| Hypoxia | 4/48 (8.3%) | 4 |
| Nasal congestion | 4/48 (8.3%) | 7 |
| Pleural effusion | 5/48 (10.4%) | 8 |
| Postnasal drip | 4/48 (8.3%) | 4 |
| Productive cough | 3/48 (6.3%) | 4 |
| Respiratory, thoracic and mediastinal disorders - Other | 11/48 (22.9%) | 15 |
| Sore throat | 9/48 (18.8%) | 18 |
| Wheezing | 4/48 (8.3%) | 8 |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 19/48 (39.6%) | 55 |
| Dry skin | 8/48 (16.7%) | 16 |
| Hyperhidrosis | 5/48 (10.4%) | 7 |
| Pain of skin | 4/48 (8.3%) | 4 |
| Palmar-plantar erythrodysesthesia syndrome | 5/48 (10.4%) | 8 |
| Pruritus | 11/48 (22.9%) | 14 |
| Skin and subcutaneous tissue disorders - Other | 23/48 (47.9%) | 51 |
| Vascular disorders | ||
| Flushing | 3/48 (6.3%) | 4 |
| Hypertension | 13/48 (27.1%) | 19 |
| Hypotension | 16/48 (33.3%) | 26 |
| Thromboembolic event | 5/48 (10.4%) | 5 |
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 | Dr. Theodore Hong |
|---|---|
| Organization | Massachusetts General Hospital |
| Phone | 617-726-6050 |
| TSHONG1@mgh.harvard.edu |
- 11-328