Trial Outcomes & Findings for Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer (NCT NCT00551421)
NCT ID: NCT00551421
Last Updated: 2015-03-31
Results Overview
The regimen was deemed intolerable so there was no recommended phase II dose.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
17 participants
Primary outcome timeframe
28 days
Results posted on
2015-03-31
Participant Flow
3 patients were enrolled into the original protocol between 11/07 and 05/08. 1 subject developed Grade 3 diarrhea, all 3 subjects experienced significant skin toxicity. The protocol was therefore amended to recruit cetuximab-refractory mCRC patients only. 14 patients were enrolled in this part of the study between 03/09 and 07/10 at 6 US centers.
One patient enrolled into the amended part of the protocol withdrew consent prior to receiving any study drug.
Participant milestones
| Measure |
Pertuzumab and Cetuximab
Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: irinotecan hydrochloride, pertuzumab, cetuximab
Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method
|
|---|---|
|
Original Protocol, Dose Level 1
STARTED
|
3
|
|
Original Protocol, Dose Level 1
COMPLETED
|
3
|
|
Original Protocol, Dose Level 1
NOT COMPLETED
|
0
|
|
Amended Protocol (Cetuximab-refr. mCRC)
STARTED
|
14
|
|
Amended Protocol (Cetuximab-refr. mCRC)
COMPLETED
|
13
|
|
Amended Protocol (Cetuximab-refr. mCRC)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pertuzumab and Cetuximab
Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: irinotecan hydrochloride, pertuzumab, cetuximab
Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method
|
|---|---|
|
Amended Protocol (Cetuximab-refr. mCRC)
Withdrawal by Subject
|
1
|
Baseline Characteristics
Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Pertuzumab and Cetuximab
n=17 Participants
Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysThe regimen was deemed intolerable so there was no recommended phase II dose.
Outcome measures
| Measure |
Pertuzumab and Cetuximab
n=14 Participants
Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: irinotecan hydrochloride, pertuzumab, cetuximab
Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method
|
|---|---|
|
Recommended Phase II Dose of Pertuzumab When Administered in Combination With Cetuximab (Phase I)
|
NA (NUMBER)
The regimen was deemed intolerable so there was no recommended phase II dose.
|
PRIMARY outcome
Timeframe: Best tumor response from time period of start of study treatment to study discontinuation.Objective tumor response rate defined as the proportion of patients with a best overall response of CR or PR, per RECIST criteria (Phase II).
Outcome measures
| Measure |
Pertuzumab and Cetuximab
n=7 Participants
Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: irinotecan hydrochloride, pertuzumab, cetuximab
Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method
|
|---|---|
|
Objective Tumor Response Rate Defined as the Proportion of Patients With a Best Overall Response of CR or PR, Per RECIST Criteria (Phase II)
Confirmed Partial Response
|
14 percentage of patients
|
|
Objective Tumor Response Rate Defined as the Proportion of Patients With a Best Overall Response of CR or PR, Per RECIST Criteria (Phase II)
Best Response of Stable Disease
|
29 percentage of patients
|
|
Objective Tumor Response Rate Defined as the Proportion of Patients With a Best Overall Response of CR or PR, Per RECIST Criteria (Phase II)
Best Response of Progressive Disease
|
57 percentage of patients
|
SECONDARY outcome
Timeframe: The duration of time from start of study treatment to time of objective disease progression or death.The duration of time from start of study treatment to time of objective disease progression or death.
Outcome measures
| Measure |
Pertuzumab and Cetuximab
n=7 Participants
Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: irinotecan hydrochloride, pertuzumab, cetuximab
Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method
|
|---|---|
|
Progression-free Survival
|
2.1 months
Interval 1.5 to 4.9
|
SECONDARY outcome
Timeframe: The duration of time from start of study treatment to death from any cause.The duration of time from start of study treatment to death from any cause.
Outcome measures
| Measure |
Pertuzumab and Cetuximab
n=7 Participants
Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: irinotecan hydrochloride, pertuzumab, cetuximab
Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method
|
|---|---|
|
Overall Survival
|
3.7 months
Interval 1.6 to 7.9
|
Adverse Events
Pertuzumab and Cetuximab
Serious events: 13 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pertuzumab and Cetuximab
n=16 participants at risk
Original Protocol: Patients received pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose on cycle 1, day 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as the Original Protocol (see above) except the Cetuximab loading dose was no longer given on cycle 1, day 2 (maintainance dose given).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: pertuzumab, cetuximab, irinotecan hydrochloride
Corrlateive studies: immunohistochemistry staining method, fluorescence in situ hybridization, gene expression analysis, mutation analysis, polymerase chain reaction, laboratory biomarker analysis
|
|---|---|
|
Cardiac disorders
cardiac ischemia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Cardiac disorders
troponin elevation
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
General disorders
insomnia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
acneiform rash
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
50.0%
8/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
skin pain
|
18.8%
3/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
small bowel obstruction
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
diarrhea
|
25.0%
4/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
mucositis or stomatitis
|
31.2%
5/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
AST elevation
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hyperbilirubinemia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hypokalemia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
hand-foot reaction
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
dehydration
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
Other adverse events
| Measure |
Pertuzumab and Cetuximab
n=16 participants at risk
Original Protocol: Patients received pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose on cycle 1, day 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Amended Protocol, Phase I: Same as the Original Protocol (see above) except the Cetuximab loading dose was no longer given on cycle 1, day 2 (maintainance dose given).
Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).
Given IV: pertuzumab, cetuximab, irinotecan hydrochloride
Corrlateive studies: immunohistochemistry staining method, fluorescence in situ hybridization, gene expression analysis, mutation analysis, polymerase chain reaction, laboratory biomarker analysis
|
|---|---|
|
Skin and subcutaneous tissue disorders
edema of head and neck
|
12.5%
2/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
General disorders
fatigue
|
81.2%
13/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
General disorders
fever without neutropenia
|
12.5%
2/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
General disorders
insomnia
|
12.5%
2/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
General disorders
rigors/chills
|
18.8%
3/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
General disorders
weight loss
|
12.5%
2/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
General disorders
weakness (non-neuropathic)
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
acneiform rash
|
25.0%
4/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
12.5%
2/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
edema of limb
|
18.8%
3/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
edema trunk/genital
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
erythema multiforme
|
18.8%
3/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
lymphedema
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
nail changes
|
25.0%
4/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
other
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
43.8%
7/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
rash/desquamation
|
31.2%
5/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Skin and subcutaneous tissue disorders
skin (other)
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
abdominal pain
|
37.5%
6/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
anorexia
|
43.8%
7/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
constipation
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
dehydration
|
12.5%
2/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
diarrhea
|
37.5%
6/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
distension/bloating
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
dyspepsia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
esophagitis
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
mucositis or stomatitis
|
31.2%
5/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
nausea
|
50.0%
8/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
vomiting
|
25.0%
4/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Renal and urinary disorders
incontinence - urinary
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Renal and urinary disorders
proteinuria
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Reproductive system and breast disorders
vaginal discharge
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Blood and lymphatic system disorders
anemia
|
56.2%
9/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Blood and lymphatic system disorders
leukopenia
|
12.5%
2/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Blood and lymphatic system disorders
lymphopenia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Infections and infestations
urinary tract
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Infections and infestations
colitis - infectious
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
ALT elevation
|
12.5%
2/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
AST elevation
|
31.2%
5/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
alkaline phosphatase elevation
|
37.5%
6/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hepatic (other)
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hyperbilirubinemia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
37.5%
6/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
43.8%
7/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
25.0%
4/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hypokalemia
|
25.0%
4/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
43.8%
7/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hyponatremia
|
25.0%
4/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
25.0%
4/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
INR elevation
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
PTT prolongation
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Metabolism and nutrition disorders
metabolic/lab (other)
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Nervous system disorders
neuropathy (sensory)
|
18.8%
3/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Eye disorders
eyelid dysfunction
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Eye disorders
blurry vision
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Eye disorders
ocular (other)
|
12.5%
2/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
General disorders
epistaxis
|
18.8%
3/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
General disorders
voice changes/dysarthria
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Psychiatric disorders
depression
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Blood and lymphatic system disorders
hemoglobin
|
12.5%
2/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Blood and lymphatic system disorders
neutropenia
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Nervous system disorders
neurologic (other)
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Gastrointestinal disorders
gastrointestinal (other)
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
|
Infections and infestations
infection (other)
|
6.2%
1/16 • Adverse event information was collected between November 2007 and October 2010.
3 patients were enrolled to Dose Level 1. 1 subject developed gr. 3 diarrhea (hospitalized), and skin toxicity was seen among the 3 subjects. The study was amended and the loading dose of cetuximab was eliminated. We report the adverse event results of the subjects enrolled on the original and the amended protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60