Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer
Study Details
Study Description
Brief Summary
The purpose of this research study is to determine if the combination of docetaxel, cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is believed to stop the formation of new blood vessels that carry nutrients to tumors. Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin and irinotecan are traditional chemotherapy agents that have been tested together in another clinical trial for esophageal and gastric cancer. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
To determine the 10-month progression-free survival rate for the combination of TPC and Bevacizumab in patients with metastatic esophageal or gastric cancer
Secondary
-
To determine the response rate (RECIST) and median duration of response
-
To determine overall survival
-
To determine toxicity
Exploratory
-
To explore if 7/7 and 7/6 UGT1A1 polymorphisms correlate with grade III/IV irinotecan-related diarrhea and neutropenia when irinotecan is given at relatively low dose to patients with esophageal and gastric cancer
-
To correlate expression of tumoral and serum VEGF with response and survival
-
To correlate TGF alpha levels and tumor microvessel density with clinical activity
-
To examine circulating endothelial cells (CECs) as surrogate markers of antitumor activity of bevacizumab
DESIGN This trial will use a single stage design to differentiate a >/= 50% rate of 10-month progression-free survival from a </= 30% rate. The proposed regimen would be promising if at least 15 of 35 patients were alive and progression-free at 10 months.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held. |
Drug: Bevacizumab
Other Names:
Drug: Docetaxel
Other Names:
Drug: Cisplatin
Other Names:
Drug: Irinotecan
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 10-month Progression-Free Survival Rate [Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months.]
10-month progression-free survival rate is the probability of patients remaining alive and progression-free at 10-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Secondary Outcome Measures
- Best Response [Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).]
Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria.
- Overall Survival [Patients in the study cohort were followed for a median of 12.2 month (up to 40 months).]
Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods.
- Progression-Free Survival [Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).]
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically confirmed, unresectable esophageal or gastric carcinoma (carcinoma=adenocarcinoma or squamous cell carcinoma)
-
Measurable disease greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan or 2 cm or greater by other radiographic technique
-
Lesions must be measurable in at least one dimension
-
Bone lesions, ascites, and effusions are not measurable
-
18 years of age or older
-
ECOG performance status 0 or 1
-
Life expectancy of at least 12 weeks
-
Adequate bone marrow function
-
Adequate renal function
-
Adequate liver function
Exclusion Criteria:
-
Prior chemotherapy (except as part of pre- or post-operative therapy, completed more than 1 year prior to start day of this protocol)
-
History of severe hypersensitivity to bevacizumab, docetaxel, cisplatin, irinotecan, or drugs formulated with polysorbate 80
-
Current, recent (within 4 weeks) or planned participation in an experimental drug study
-
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study
-
Minor surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies within 7 days prior to Day 0 of study
-
Myocardial infarction or stroke in past 6 months
-
Blood pressure of > 150/100 mmHg
-
Unstable angina
-
New York Heart Association (NYHA) grade II or greater congestive heart failure
-
Clinically significant peripheral vascular disease
-
Persistent bleeding from primary tumor, while off anticoagulants, requiring repeated transfusions
-
Evidence of bleeding diathesis or coagulopathy
-
Uncontrolled serious medical or psychiatric illness
-
Uncontrolled diarrhea
-
Peripheral neuropathy > grade 1
-
Clinically apparent central nervous system metastases or carcinomatous meningitis
-
Other active malignancy other than non-melanoma skin cancer or in situ cervical carcinoma.
-
Urine protein: creatinine ratio of 1.0 or greater at screening
-
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
-
Serious non-healing wound, ulcer, or bone fracture
-
Pregnant or breast-feeding
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
2 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02115 |
3 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Dana-Farber Cancer Institute
- Brigham and Women's Hospital
- Massachusetts General Hospital
- Genentech, Inc.
Investigators
- Principal Investigator: Peter Enzinger, MD, Dana-Farber Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 06-100
Study Results
Participant Flow
Recruitment Details | Patients (n=38) were enrolled between September 2006 and March 2008. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
---|---|
Arm/Group Description | Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held. |
Period Title: Overall Study | |
STARTED | 38 |
Evaluable and Treated | 35 |
COMPLETED | 35 |
NOT COMPLETED | 3 |
Baseline Characteristics
Arm/Group Title | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
---|---|
Arm/Group Description | Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held. |
Overall Participants | 38 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
58
|
Sex: Female, Male (Count of Participants) | |
Female |
6
15.8%
|
Male |
32
84.2%
|
Race/Ethnicity, Customized (Count of Participants) | |
White |
33
86.8%
|
Black or African American |
2
5.3%
|
Hispanic |
3
7.9%
|
Region of Enrollment (Count of Participants) | |
United States |
38
100%
|
Primary Site of Disease (Count of Participants) | |
Esophageal |
13
34.2%
|
Gastroesophageal junction |
9
23.7%
|
Gastric |
16
42.1%
|
Outcome Measures
Title | 10-month Progression-Free Survival Rate |
---|---|
Description | 10-month progression-free survival rate is the probability of patients remaining alive and progression-free at 10-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. |
Time Frame | Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months. |
Outcome Measure Data
Analysis Population Description |
---|
The analysis dataset is comprised of all enrolled patients. |
Arm/Group Title | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
---|---|
Arm/Group Description | Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held. |
Measure Participants | 38 |
Number (95% Confidence Interval) [probability (%)] |
40.0
|
Title | Best Response |
---|---|
Description | Best response on treatment was based on RECIST 1.0 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Both require confirmation no fewer than 4 weeks apart. CR/PR assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Progressive disease (PD) is at least a 20% increase in the sum of longest diameter of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. Stable disease is defined as any condition not meeting above criteria. |
Time Frame | Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles). |
Outcome Measure Data
Analysis Population Description |
---|
The analysis dataset is comprised of all treated and evaluable patients. |
Arm/Group Title | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
---|---|
Arm/Group Description | Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held. |
Measure Participants | 35 |
Partial Response |
23
60.5%
|
Stable Disease |
7
18.4%
|
Progressive Disease |
5
13.2%
|
Title | Overall Survival |
---|---|
Description | Overall survival is defined as the time from study entry to death or date last known alive and estimate using Kaplan-Meier (KM) methods. |
Time Frame | Patients in the study cohort were followed for a median of 12.2 month (up to 40 months). |
Outcome Measure Data
Analysis Population Description |
---|
The analysis dataset is comprised of all enrolled patients. |
Arm/Group Title | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
---|---|
Arm/Group Description | Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held. |
Measure Participants | 38 |
Median (95% Confidence Interval) [months] |
14.9
|
Title | Progression-Free Survival |
---|---|
Description | Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Patients alive and progression-free at last follow-up are censored. Per RECIST 1.0 criteria: progressive disease is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. |
Time Frame | Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles). |
Outcome Measure Data
Analysis Population Description |
---|
The analysis dataset is comprised of all enrolled patients. |
Arm/Group Title | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) |
---|---|
Arm/Group Description | Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held. |
Measure Participants | 38 |
Median (95% Confidence Interval) [months] |
8.9
|
Adverse Events
Time Frame | Adverse events were assessed weeks 1 and 2 each cycle throughout treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles). | |
---|---|---|
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. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3. No further data is available to specify classification of other beyond the general term. | |
Arm/Group Title | Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) | |
Arm/Group Description | Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held. | |
All Cause Mortality |
||
Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) | ||
Affected / at Risk (%) | # Events | |
Total | 30/38 (78.9%) | |
Blood and lymphatic system disorders | ||
Hemoglobin | 2/38 (5.3%) | |
Febrile neutropenia | 6/38 (15.8%) | |
Gastrointestinal disorders | ||
Constipation | 1/38 (2.6%) | |
Diarrhea w/o prior colostomy | 16/38 (42.1%) | |
Dysphagia | 1/38 (2.6%) | |
Esophagitis | 2/38 (5.3%) | |
Ileus | 1/38 (2.6%) | |
Nausea | 4/38 (10.5%) | |
Vomiting | 2/38 (5.3%) | |
Upper GI, hemorrhage NOS | 2/38 (5.3%) | |
Abdomen, pain | 2/38 (5.3%) | |
General disorders | ||
Fatigue | 7/38 (18.4%) | |
Immune system disorders | ||
Allergic reaction | 1/38 (2.6%) | |
Infections and infestations | ||
Infection w/ gr3-4 neut, vulva | 1/38 (2.6%) | |
Infection Gr0-2 neut, lung | 1/38 (2.6%) | |
Infection Gr 0-2 neut, blood | 1/38 (2.6%) | |
Investigations | ||
Leukocytes | 9/38 (23.7%) | |
Lymphopenia | 12/38 (31.6%) | |
Neutrophils | 12/38 (31.6%) | |
Weight gain | 1/38 (2.6%) | |
INR | 1/38 (2.6%) | |
ALT, SGPT | 1/38 (2.6%) | |
Metabolism and nutrition disorders | ||
Anorexia | 6/38 (15.8%) | |
Dehydration | 5/38 (13.2%) | |
Hypoalbuminemia | 1/38 (2.6%) | |
Hypocalcemia | 3/38 (7.9%) | |
Hyperglycemia | 1/38 (2.6%) | |
Hypomagnesemia | 2/38 (5.3%) | |
Hypophosphatemia | 2/38 (5.3%) | |
Hypokalemia | 6/38 (15.8%) | |
Hyponatremia | 4/38 (10.5%) | |
Nervous system disorders | ||
Neuropathy-motor | 1/38 (2.6%) | |
Syncope | 1/38 (2.6%) | |
Respiratory, thoracic and mediastinal disorders | ||
Hiccoughs | 1/38 (2.6%) | |
Nasal cavity/paranasal sinus reaction | 1/38 (2.6%) | |
Pulmonary/Upper Respiratory-other | 1/38 (2.6%) | |
Vascular disorders | ||
Hypertension | 2/38 (5.3%) | |
Hypotension | 1/38 (2.6%) | |
Thrombosis/thrombus/embolism | 6/38 (15.8%) | |
Other (Not Including Serious) Adverse Events |
||
Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) | ||
Affected / at Risk (%) | # Events | |
Total | 37/38 (97.4%) | |
Blood and lymphatic system disorders | ||
Hemoglobin | 28/38 (73.7%) | |
Hematologic | 5/38 (13.2%) | |
Lymphatics | 1/38 (2.6%) | |
Ear and labyrinth disorders | ||
Hearing | 1/38 (2.6%) | |
External ear, pain | 1/38 (2.6%) | |
Eye disorders | ||
Vision-blurred | 1/38 (2.6%) | |
Tearing | 3/38 (7.9%) | |
Ocular | 1/38 (2.6%) | |
Gastrointestinal disorders | ||
Ascites (non-malignant) | 1/38 (2.6%) | |
Constipation | 22/38 (57.9%) | |
Diarrhea w/o prior colostomy | 19/38 (50%) | |
Distention/bloating, abdominal | 3/38 (7.9%) | |
Dry mouth | 1/38 (2.6%) | |
Dysphagia | 4/38 (10.5%) | |
Flatulence | 7/38 (18.4%) | |
Dyspepsia | 7/38 (18.4%) | |
Hemorrhoids | 1/38 (2.6%) | |
Muco/stomatitis by exam, oral cavity | 7/38 (18.4%) | |
Muco/stomatitis (symptom) oral cavity | 3/38 (7.9%) | |
Nausea | 30/38 (78.9%) | |
Ulcer, rectum | 1/38 (2.6%) | |
Vomiting | 24/38 (63.2%) | |
GI-other | 8/38 (21.1%) | |
Rectum, hemorrhage | 1/38 (2.6%) | |
Abdomen, pain | 18/38 (47.4%) | |
Esophagus, pain | 1/38 (2.6%) | |
Oral cavity, pain | 2/38 (5.3%) | |
Rectum, pain | 1/38 (2.6%) | |
Stomach, pain | 7/38 (18.4%) | |
General disorders | ||
Fatigue | 28/38 (73.7%) | |
Fever w/o neutropenia | 6/38 (15.8%) | |
Rigors/chills | 4/38 (10.5%) | |
Constitutional | 1/38 (2.6%) | |
Injection site reaction | 1/38 (2.6%) | |
Edema limb | 5/38 (13.2%) | |
Chest/thoracic pain NOS | 5/38 (13.2%) | |
Pain NOS | 3/38 (7.9%) | |
Pain-other | 3/38 (7.9%) | |
Hepatobiliary disorders | ||
Liver, pain | 1/38 (2.6%) | |
Immune system disorders | ||
Allergic reaction | 2/38 (5.3%) | |
Allergy-other | 1/38 (2.6%) | |
Infections and infestations | ||
Infection w/ gr3-4 neut, skin | 1/38 (2.6%) | |
Infection Gr0-2 neut, lung | 1/38 (2.6%) | |
Infection-other | 2/38 (5.3%) | |
Injury, poisoning and procedural complications | ||
Wound - non-infectious | 2/38 (5.3%) | |
Investigations | ||
Leukocytes | 20/38 (52.6%) | |
Lymphopenia | 7/38 (18.4%) | |
Neutrophils | 11/38 (28.9%) | |
Platelets | 8/38 (21.1%) | |
Weight gain | 1/38 (2.6%) | |
Weight loss | 7/38 (18.4%) | |
Alkaline phosphatase | 7/38 (18.4%) | |
ALT, SGPT | 8/38 (21.1%) | |
AST, SGOT | 8/38 (21.1%) | |
Bilirubin | 2/38 (5.3%) | |
Creatinine | 6/38 (15.8%) | |
Metabolism and nutrition disorders | ||
Anorexia | 18/38 (47.4%) | |
Dehydration | 15/38 (39.5%) | |
Hypoalbuminemia | 13/38 (34.2%) | |
Bicarbonate | 8/38 (21.1%) | |
Hypocalcemia | 15/38 (39.5%) | |
Hyperglycemia | 13/38 (34.2%) | |
Hypoglycemia | 2/38 (5.3%) | |
Hypomagnesemia | 10/38 (26.3%) | |
Hypophosphatemia | 3/38 (7.9%) | |
Hyperkalemia | 10/38 (26.3%) | |
Hypokalemia | 6/38 (15.8%) | |
Hypernatremia | 2/38 (5.3%) | |
Hyponatremia | 17/38 (44.7%) | |
Musculoskeletal and connective tissue disorders | ||
Arthritis | 1/38 (2.6%) | |
Nonneuropathic lower extr muscle weak | 1/38 (2.6%) | |
Nonneuropathic generalized weakness | 7/38 (18.4%) | |
Back, pain | 2/38 (5.3%) | |
Chest wall, pain | 1/38 (2.6%) | |
Extremity-limb, pain | 1/38 (2.6%) | |
Joint, pain | 3/38 (7.9%) | |
Muscle, pain | 2/38 (5.3%) | |
Nervous system disorders | ||
Taste disturbance | 13/38 (34.2%) | |
Dizziness | 15/38 (39.5%) | |
Neuropathy-motor | 2/38 (5.3%) | |
Neuropathy-sensory | 11/38 (28.9%) | |
Head/headache | 10/38 (26.3%) | |
Psychiatric disorders | ||
Insomnia | 7/38 (18.4%) | |
Anxiety | 3/38 (7.9%) | |
Depression | 3/38 (7.9%) | |
Libido | 1/38 (2.6%) | |
Renal and urinary disorders | ||
Glomerular filtration rate | 1/38 (2.6%) | |
Proteinuria | 1/38 (2.6%) | |
Urinary frequency/urgency | 1/38 (2.6%) | |
Reproductive system and breast disorders | ||
Pelvic, pain | 1/38 (2.6%) | |
Erectile impotence | 1/38 (2.6%) | |
Respiratory, thoracic and mediastinal disorders | ||
Allergic rhinitis | 11/38 (28.9%) | |
Muco/stomatitis (symptom) trachea | 1/38 (2.6%) | |
Nose, hemorrhage | 13/38 (34.2%) | |
Throat/pharynx/larynx, pain | 3/38 (7.9%) | |
Cough | 7/38 (18.4%) | |
Dyspnea | 7/38 (18.4%) | |
Hiccoughs | 1/38 (2.6%) | |
Nasal cavity/paranasal sinus reaction | 3/38 (7.9%) | |
Pleural effusion (non-malignant) | 1/38 (2.6%) | |
Voice changes/dysarthria | 12/38 (31.6%) | |
Pulmonary/Upper Respiratory | 1/38 (2.6%) | |
Skin and subcutaneous tissue disorders | ||
Erythema multiforme | 3/38 (7.9%) | |
Sweating | 1/38 (2.6%) | |
Dry skin | 2/38 (5.3%) | |
Alopecia | 19/38 (50%) | |
Nail changes | 4/38 (10.5%) | |
Pruritus/itching | 1/38 (2.6%) | |
Rash/desquamation | 2/38 (5.3%) | |
Rash: acne/acneiform | 1/38 (2.6%) | |
Hand-foot reaction | 2/38 (5.3%) | |
Ulceration | 1/38 (2.6%) | |
Skin | 5/38 (13.2%) | |
Petechiae | 1/38 (2.6%) | |
Scalp, pain | 1/38 (2.6%) | |
Vascular disorders | ||
Hemorrhage | 1/38 (2.6%) | |
Hypertension | 6/38 (15.8%) | |
Hypotension | 1/38 (2.6%) | |
Hot flashes | 3/38 (7.9%) | |
Hemorrhage | 3/38 (7.9%) |
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 | Peter C. Enzinger, MD |
---|---|
Organization | Dana-Farber Cancer Institute |
Phone | 617-632-6855 |
Peter_Enzinger@dfci.harvard.edu |
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