Study in Advanced Solid Tumors
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01099358
Collaborator
(none)
47
7
4
73
6.7
0.1
Study Details
Study Description
Brief Summary
The primary purpose of this study is to help answer the following research question(s):
-
To see how the body absorbs, processes, and gets rid of cetuximab when the drug is taken in combination with cisplatin [pharmacokinetic (PK) analysis]
-
To see if any drug interactions occur between cetuximab and cisplatin.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
47 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Phase 2 Study to Evaluate the Pharmacokinetics and Drug-Drug Interaction of Cetuximab and Cisplatin in Patients With Advanced Solid Tumors
Study Start Date
:
Apr 1, 2010
Actual Primary Completion Date
:
Oct 1, 2015
Actual Study Completion Date
:
May 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cetuximab and Cisplatin (D) Cycle 1 (1 week, combination therapy): 400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1. 100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1. After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. |
Drug: Cetuximab
Administered Intravenously
Drug: Cisplatin
Administered Intravenously
Drug: 5 - Fluorouracil
Administered Intravenously
|
| Experimental: Cetuximab and Cisplatin (C) Cycle 1 (4 weeks, combination therapy): 100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 (3 weeks combination therapy): 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. |
Drug: Cetuximab
Administered Intravenously
Drug: Cisplatin
Administered Intravenously
Drug: 5 - Fluorouracil
Administered Intravenously
|
| Experimental: Cetuximab on Cisplatin (B) Cycle 1: 400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1. Cycle 2: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cycle 3 + : 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. |
Drug: Cetuximab
Administered Intravenously
Drug: Cisplatin
Administered Intravenously
Drug: 5 - Fluorouracil
Administered Intravenously
|
| Experimental: Cisplatin on Cetuximab (A) Cycle 1: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1. Cycle 2 +: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. |
Drug: Cetuximab
Administered Intravenously
Drug: Cisplatin
Administered Intravenously
Drug: 5 - Fluorouracil
Administered Intravenously
|
Outcome Measures
Primary Outcome Measures
- Total Cisplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) [Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).]
- Cetuximab Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss) [Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).]
- Total Cisplatin Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) [Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).]
- Cetuximab Pharmacokinetics: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) [Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).]
- Total Cisplatin Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax) [Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion).]
- Cetuximab Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax) [Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion).]
- Cetuximab Pharmacokinetics: Confirmatory Serum Concentration [Group D:Cycle 1, Day 1: Prior to Cisplatin Infusion.]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
The participant has histologically or cytologically advanced solid tumor that is resistant to standard therapy or for which there is no standard therapy.
-
The participant has measurable or non-measurable disease.
-
The participant has a life expectancy of greater than 3 months.
-
The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
-
The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (μL), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/μL.
-
The participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).
-
The participant has adequate renal function as defined by serum creatinine less than or equal to 1.5 x the institutional ULN or creatinine clearance greater than or equal to 60 mL/min for participants with creatinine levels above the ULN.
-
The participant has the ability to understand, and the willingness to sign, a written informed consent document.
-
If the participant has received prior therapy with platinum, the time to the first treatment of study drug from the last platinum exposure is >28 days.
Exclusion Criteria:
-
The participant has symptomatic brain or leptomeningeal metastasis.
-
The participant has not recovered from Adverse Events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.
-
The participant is receiving any other investigational agent(s).
-
The participant is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiation therapy (RT), chemoembolization, or targeted therapy. Participants receiving palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible.
-
The participant is receiving therapy with immunosuppressive agents.
-
The participant has known drug or alcohol abuse.
-
The participant has uncontrolled hypertension defined as systolic blood pressure greater than or equal to 180 millimeters of mercury (mm Hg) or diastolic blood pressure greater than or equal to 130 mm Hg.
-
The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or cisplatin.
-
The participant has a medical or psychological condition that would not permit the participant to complete the study or sign informed consent.
-
The participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
-
The participant, if female, is pregnant (confirmed by serum or urine beta-human chorionic gonadotropin [β-HCG] pregnancy test) or breastfeeding
-
The participant has had a known positive test result for the human immunodeficiency virus.
-
The participant has an active infection (requiring intravenous [IV] antibiotics), including tuberculosis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Highlands Oncology Group | Fayetteville | Arkansas | United States | 72703 |
| 2 | University of Kansas Medical Center | Fairway | Kansas | United States | 66205 |
| 3 | VA Sierra Nevada Health Care System | Reno | Nevada | United States | 89502 |
| 4 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599 |
| 5 | University of Texas Health Science Center - San Antonio | San Antonio | Texas | United States | 78229 |
| 6 | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | London | Canada | N6A 4L6 | |
| 7 | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Toronto | Canada | M5G 2M9 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01099358
Other Study ID Numbers:
- 13418
- I4E-MC-JXBA
First Posted:
Apr 7, 2010
Last Update Posted:
Sep 26, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Due to protocol amendment in September 2011,any newly enrolled participants were placed into cetuximab and cisplatin(C) arm only.After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab(cet) and cisplatin(D) arm only. Group(Grp)A (cisplatin [cis]) completed 3 infusions(inf) of cet (Weeks(wk) 2,3, & 4 |
|---|---|
| Pre-assignment Detail | [wk 4 = wk 1 of cycle(cyc) 2]) & 2 inf of cis(wk 1 & 4) first 4 wks.Grp B (cet) completed 4 inf of cet (wk 1-4) & 1 inf of cis(wk 4) first 4 wks. Grp C(cis and cet) completed 4 inf of cet(wk 2,3,4, & 5) & 2 inf of cis(wk 1 & 5) first 5 wk. Grp D(cis) completed 1 inf of cet(cyc 1) & 1 inf of cis(wk 1 of cyc 1) and without deviation. |
| Arm/Group Title | Cisplatin on Cetuximab (A) | Cetuximab on Cisplatin (B) | Cetuximab and Cisplatin (C) | Cetuximab and Cisplatin (D) |
|---|---|---|---|---|
| Arm/Group Description | Cycle 1: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1. Cycle 2 +: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. | Cycle 1: 400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1. Cycle 2: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cycle 3 + : 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. | Cycle 1 (4 weeks, combination therapy): 100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 (3 weeks combination therapy): 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. | Cycle 1 (1 week, combination therapy): 400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1. 100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1. After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. |
| Period Title: Overall Study | ||||
| STARTED | 4 | 6 | 21 | 16 |
| Received at Least One Dose of Study Drug | 3 | 6 | 20 | 15 |
| COMPLETED | 1 | 5 | 13 | 12 |
| NOT COMPLETED | 3 | 1 | 8 | 4 |
Baseline Characteristics
| Arm/Group Title | All Participants (All Participants (Group A, B, C and D) |
|---|---|
| Arm/Group Description | A:Cycle1:100mg/m² cisplatin(cs) I.V on week(w)1,day(d)1. 5-FU as a 96-hour(h) C.I. of 1000 mg/m²/d starting (st) on w 1,d 1-4. 400mg/m² cetuximab(ct) I.V on w 2,d 1.250mg/m² ct I.V on w 3,d 1.Cycle 2+100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.250mg/m² ct I.V on w 1-3,d 1. B:Cycle1:400mg/m² ct I.V on w 1,d 1.250mg/m² ct I.V on w 2&3,d 1.Cycle 2:100mg/m² cs I.V on w 1, d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1- 4.250mg/m² ct I.V on w 1-3,d 1.Cycle 3 +:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4. 250mg/m² ct I.V on w 1-3,d 1. C:Cycle1:100mg/m² cs I.V on w 1, d 1. 5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1.400 mg/m² ct I.V on w 2,d 1.250mg/m² ct I.V on w 3&4,d 1.Cycle2-6:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1. 250mg/m² ct I.V w 1,2,&3,d 1. D:Cycle1:400mg/m² ct I.V w 1,d 1.100mg/m² cs I.V w 1,d 1.Optional 5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1. |
| Overall Participants | 44 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
56.6
(11.29)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
19
43.2%
|
| Male |
25
56.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
3
6.8%
|
| Not Hispanic or Latino |
38
86.4%
|
| Unknown or Not Reported |
3
6.8%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
4
9.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
5
11.4%
|
| White |
34
77.3%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
1
2.3%
|
| Region of Enrollment (participants) [Number] | |
| Canada |
16
36.4%
|
| United States |
28
63.6%
|
Outcome Measures
| Title | Total Cisplatin Pharmacokinetics (PK): Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) |
|---|---|
| Description | |
| Time Frame | Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D. |
| Arm/Group Title | Cetuximab (A and C) | Cetuximab and Cisplatin (A and C) |
|---|---|---|
| Arm/Group Description | Cisplatin on Cetuximab (A) Cycle 1: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1. Cycle 2 +: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 (4 weeks, combination therapy): 100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 (3 weeks combination therapy): 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. | Cisplatin on Cetuximab (A) Cycle 1: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1. Cycle 2 +: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 (4 weeks, combination therapy): 100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 (3 weeks combination therapy): 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. |
| Measure Participants | 5 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [micrograms*hour/milliliters (μg*h/mL)] |
324
(24.5)
|
338
(26.1)
|
| Title | Cetuximab Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC τ,ss) |
|---|---|
| Description | |
| Time Frame | Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug who were enrolled in Group B or C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D. |
| Arm/Group Title | Cetuximab (B and C) | Cetuximab and Cisplatin (B and C) |
|---|---|---|
| Arm/Group Description | Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1. Cycle 2: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cycle 3 + : 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. | Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1. Cycle 2: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cycle 3 + : 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. |
| Measure Participants | 14 | 14 |
| Geometric Mean (Geometric Coefficient of Variation) [micrograms*hour/milliliters (μg*h/mL)] |
15000
(25.7)
|
16200
(22.5)
|
| Title | Total Cisplatin Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) |
|---|---|
| Description | |
| Time Frame | Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D. |
| Arm/Group Title | Cetuximab (A and C) | Cetuximab and Cisplatin (A and C) |
|---|---|---|
| Arm/Group Description | Cisplatin on Cetuximab (A) Cycle 1: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1. Cycle 2 +: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 (4 weeks, combination therapy): 100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 (3 weeks combination therapy): 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. | Cisplatin on Cetuximab (A) Cycle 1: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1. Cycle 2 +: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 (4 weeks, combination therapy): 100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 (3 weeks combination therapy): 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. |
| Measure Participants | 5 | 5 |
| Geometric Mean (Geometric Coefficient of Variation) [micrograms/milliliters(μg/mL)] |
4.08
(23.2)
|
4.22
(10.2)
|
| Title | Cetuximab Pharmacokinetics: Maximum Observed Plasma Concentration at Steady State (Cmax,ss) |
|---|---|
| Description | |
| Time Frame | Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D. |
| Arm/Group Title | Cetuximab (B and C) | Cetuximab and Cisplatin (B and C) |
|---|---|---|
| Arm/Group Description | Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1. Cycle 2: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cycle 3 + : 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. | Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1. Cycle 2: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cycle 3 + : 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. |
| Measure Participants | 14 | 14 |
| Geometric Mean (Geometric Coefficient of Variation) [micrograms per milliliters (μg/mL)] |
194
(20.6)
|
192
(12.8)
|
| Title | Total Cisplatin Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax) |
|---|---|
| Description | |
| Time Frame | Groups A and C: Cycle 1,Day 1 and Cycle 2 Day 1; Baseline (Prior to Cisplatin Infusion), 1, 1.50, 2, 3, 5, 8, 24, 72 hours (After the Start of Cisplatin Infusion). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug who were enrolled in Group A or C and had evaluable PK data. Study design by intent did not collect data from Group B or Group D. |
| Arm/Group Title | Cetuximab (A and C) | Cetuximab and Cisplatin (A and C) |
|---|---|---|
| Arm/Group Description | Cisplatin on Cetuximab (A) Cycle 1: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1. Cycle 2 +: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 (4 weeks, combination therapy): 100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 (3 weeks combination therapy): 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. | Cisplatin on Cetuximab (A) Cycle 1: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1. Cycle 2 +: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 (4 weeks, combination therapy): 100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 (3 weeks combination therapy): 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. |
| Measure Participants | 5 | 5 |
| Median (Full Range) [Hours (h)] |
1.02
|
1.05
|
| Title | Cetuximab Pharmacokinetics: Measurement of the Time After Administration When the Maximum Plasma Concentration is Reached (Tmax) |
|---|---|
| Description | |
| Time Frame | Group B:Cycle 1,Day 15 and Cycle 2, Day 1 and Group C: Cycle 1, Day 22 and Cycle 2, Day 1: Baseline (Prior to Cetuximab Infusion),1, 2, 4, 8, 24, 72, 120, and 168 hours (After the Start of Cetuximab Infusion). |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug who were enrolled in Group B and C and had evaluable PK data. Study design by intent did not collect data from Group A or Group D. |
| Arm/Group Title | Cetuximab (B and C) | Cetuximab and Cisplatin (B and C) |
|---|---|---|
| Arm/Group Description | Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1. Cycle 2: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cycle 3 + : 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. | Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1. Cycle 2: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cycle 3 + : 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. |
| Measure Participants | 14 | 14 |
| Median (Full Range) [Hours (h)] |
2.00
|
1.99
|
| Title | Cetuximab Pharmacokinetics: Confirmatory Serum Concentration |
|---|---|
| Description | |
| Time Frame | Group D:Cycle 1, Day 1: Prior to Cisplatin Infusion. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received at least one dose of study drug who were enrolled in Group D and had evaluable PK data. |
| Arm/Group Title | Cetuximab (D) |
|---|---|
| Arm/Group Description | Cetuximab and Cisplatin (D) Cycle 1 (1 week, combination therapy): 400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1. 100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1. |
| Measure Participants | 11 |
| Geometric Mean (Geometric Coefficient of Variation) [micrograms per milliliters (μg/mL)] |
198
(18.5)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All participants who received at least one dose of study drug. | |||||||
| Arm/Group Title | Cisplatin on Cetuximab (A) | Cetuximab on Cisplatin (B) | Cetuximab and Cisplatin (C) | Cetuximab and Cisplatin (D) | ||||
| Arm/Group Description | Cisplatin on Cetuximab (A) Cycle 1: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1. Cycle 2 +: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. | Cetuximab on Cisplatin (B) Cycle 1: 400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1. Cycle 2: 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. Cycle 3 + : 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4. 250 mg/m² cetuximab admin I.V on week 1-3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. | Cetuximab and Cisplatin (C) Cycle 1 (4 weeks, combination therapy): 100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1. Cycle 2-6 (3 weeks combination therapy): 100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. | Cetuximab and Cisplatin (D) Cycle 1 (1 week, combination therapy): 400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1. 100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1. After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only. | ||||
All Cause Mortality |
||||||||
| Cisplatin on Cetuximab (A) | Cetuximab on Cisplatin (B) | Cetuximab and Cisplatin (C) | Cetuximab and Cisplatin (D) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Cisplatin on Cetuximab (A) | Cetuximab on Cisplatin (B) | Cetuximab and Cisplatin (C) | Cetuximab and Cisplatin (D) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 3/6 (50%) | 12/20 (60%) | 6/15 (40%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Febrile neutropenia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 3/20 (15%) | 3 | 0/15 (0%) | 0 |
| Leukocytosis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Leukopenia | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Neutropenia | 2/3 (66.7%) | 2 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Pancytopenia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Cardiac disorders | ||||||||
| Atrial fibrillation | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 2 | 0/15 (0%) | 0 |
| Abdominal pain upper | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 2/15 (13.3%) | 2 |
| Diarrhoea | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Dyspepsia | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Dysphagia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Ileus | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Nausea | 2/3 (66.7%) | 2 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Oesophagitis | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Stomatitis | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Upper gastrointestinal haemorrhage | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Vomiting | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| General disorders | ||||||||
| Death | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Fatigue | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Mucosal inflammation | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Pyrexia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Immune system disorders | ||||||||
| Anaphylactic reaction | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Infections and infestations | ||||||||
| Bacteraemia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Pneumonia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/20 (10%) | 2 | 0/15 (0%) | 0 |
| Sepsis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Pubis fracture | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Investigations | ||||||||
| Blood creatinine increased | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Dehydration | 2/3 (66.7%) | 3 | 1/6 (16.7%) | 1 | 2/20 (10%) | 2 | 0/15 (0%) | 0 |
| Failure to thrive | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Hyperkalaemia | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Hypomagnesaemia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 1/15 (6.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Tumour haemorrhage | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Nervous system disorders | ||||||||
| Encephalopathy | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Syncope | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 3/20 (15%) | 3 | 0/15 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Acute kidney injury | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Bladder outlet obstruction | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Renal failure | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Dyspnoea | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 2 |
| Pleural effusion | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
| Vascular disorders | ||||||||
| Thrombophlebitis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 1/20 (5%) | 1 | 0/15 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Cisplatin on Cetuximab (A) | Cetuximab on Cisplatin (B) | Cetuximab and Cisplatin (C) | Cetuximab and Cisplatin (D) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | 6/6 (100%) | 20/20 (100%) | 15/15 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/20 (20%) | 4 | 4/15 (26.7%) | 6 |
| Febrile neutropenia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/20 (10%) | 2 | 0/15 (0%) | 0 |
| Leukopenia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 3/20 (15%) | 8 | 0/15 (0%) | 0 |
| Lymphopenia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/20 (20%) | 10 | 1/15 (6.7%) | 1 |
| Neutropenia | 0/3 (0%) | 0 | 3/6 (50%) | 5 | 6/20 (30%) | 13 | 3/15 (20%) | 5 |
| Thrombocytopenia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Ear and labyrinth disorders | ||||||||
| Hypoacusis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Tinnitus | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 2/20 (10%) | 3 | 1/15 (6.7%) | 1 |
| Endocrine disorders | ||||||||
| Hypothyroidism | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Eye disorders | ||||||||
| Eye pain | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Ocular discomfort | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain upper | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Constipation | 1/3 (33.3%) | 1 | 2/6 (33.3%) | 2 | 7/20 (35%) | 7 | 4/15 (26.7%) | 4 |
| Dental caries | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Diarrhoea | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 9/20 (45%) | 14 | 9/15 (60%) | 11 |
| Dry mouth | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Dyspepsia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/20 (20%) | 6 | 1/15 (6.7%) | 1 |
| Dysphagia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Flatulence | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Haematochezia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Haemorrhoids | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Mouth ulceration | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Nausea | 1/3 (33.3%) | 2 | 2/6 (33.3%) | 3 | 18/20 (90%) | 25 | 8/15 (53.3%) | 10 |
| Oesophagitis | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Oral pain | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Stomatitis | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 9/20 (45%) | 14 | 2/15 (13.3%) | 2 |
| Vomiting | 2/3 (66.7%) | 3 | 1/6 (16.7%) | 2 | 8/20 (40%) | 13 | 4/15 (26.7%) | 6 |
| General disorders | ||||||||
| Asthenia | 2/3 (66.7%) | 3 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Chills | 2/3 (66.7%) | 2 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Fatigue | 3/3 (100%) | 4 | 3/6 (50%) | 4 | 10/20 (50%) | 18 | 7/15 (46.7%) | 7 |
| Localised oedema | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Malaise | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Mucosal inflammation | 1/3 (33.3%) | 1 | 2/6 (33.3%) | 3 | 7/20 (35%) | 12 | 1/15 (6.7%) | 1 |
| Non-cardiac chest pain | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Oedema peripheral | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/20 (10%) | 2 | 1/15 (6.7%) | 1 |
| Pain | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Pyrexia | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 4/20 (20%) | 4 | 0/15 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Hyperbilirubinaemia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Immune system disorders | ||||||||
| Drug hypersensitivity | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 2/15 (13.3%) | 2 |
| Hypersensitivity | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Infections and infestations | ||||||||
| Candida infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/20 (10%) | 2 | 0/15 (0%) | 0 |
| Clostridium difficile colitis | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Clostridium difficile infection | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Escherichia urinary tract infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Nail infection | 0/3 (0%) | 0 | 1/6 (16.7%) | 3 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Oral candidiasis | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Paronychia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Skin infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Subcutaneous abscess | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Urinary tract infection | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Injury, poisoning and procedural complications | ||||||||
| Infusion related reaction | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 2/15 (13.3%) | 2 |
| Investigations | ||||||||
| Alanine aminotransferase increased | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/20 (10%) | 4 | 1/15 (6.7%) | 1 |
| Aspartate aminotransferase increased | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Blood alkaline phosphatase increased | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 2/15 (13.3%) | 2 |
| Blood creatinine increased | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 2/20 (10%) | 3 | 0/15 (0%) | 0 |
| Blood lactate dehydrogenase increased | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Blood urea increased | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Glomerular filtration rate decreased | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Haemoglobin decreased | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 2/20 (10%) | 6 | 0/15 (0%) | 0 |
| Hepatic enzyme increased | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Lymphocyte count decreased | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 2 |
| Neutrophil count decreased | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 6/20 (30%) | 19 | 2/15 (13.3%) | 2 |
| Platelet count decreased | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 3 | 5/20 (25%) | 6 | 1/15 (6.7%) | 2 |
| Weight decreased | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 4/20 (20%) | 5 | 2/15 (13.3%) | 2 |
| White blood cell count decreased | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 3/20 (15%) | 9 | 3/15 (20%) | 3 |
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 1/3 (33.3%) | 3 | 1/6 (16.7%) | 4 | 7/20 (35%) | 11 | 3/15 (20%) | 3 |
| Dehydration | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 6/20 (30%) | 6 | 3/15 (20%) | 3 |
| Hypercalcaemia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Hyperglycaemia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 2/20 (10%) | 2 | 1/15 (6.7%) | 1 |
| Hypermagnesaemia | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Hypoalbuminaemia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 1/15 (6.7%) | 2 |
| Hypocalcaemia | 2/3 (66.7%) | 4 | 1/6 (16.7%) | 1 | 2/20 (10%) | 3 | 1/15 (6.7%) | 1 |
| Hypokalaemia | 1/3 (33.3%) | 2 | 0/6 (0%) | 0 | 6/20 (30%) | 13 | 3/15 (20%) | 4 |
| Hypomagnesaemia | 2/3 (66.7%) | 5 | 1/6 (16.7%) | 3 | 12/20 (60%) | 32 | 3/15 (20%) | 5 |
| Hyponatraemia | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 5/20 (25%) | 9 | 0/15 (0%) | 0 |
| Hypophosphataemia | 1/3 (33.3%) | 1 | 1/6 (16.7%) | 1 | 2/20 (10%) | 2 | 1/15 (6.7%) | 1 |
| Malnutrition | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Musculoskeletal chest pain | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Adenocarcinoma of colon | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Nervous system disorders | ||||||||
| Dizziness | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/20 (10%) | 3 | 2/15 (13.3%) | 2 |
| Dysgeusia | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 2/20 (10%) | 3 | 0/15 (0%) | 0 |
| Headache | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Hypoaesthesia | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Lethargy | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Peripheral sensory neuropathy | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 3/20 (15%) | 4 | 0/15 (0%) | 0 |
| Syncope | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 3/15 (20%) | 3 |
| Psychiatric disorders | ||||||||
| Anxiety | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/20 (10%) | 2 | 1/15 (6.7%) | 1 |
| Confusional state | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Insomnia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 2/15 (13.3%) | 2 |
| Sleep disorder | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Proteinuria | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 3/20 (15%) | 5 | 0/15 (0%) | 0 |
| Renal impairment | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 3/20 (15%) | 4 | 1/15 (6.7%) | 1 |
| Dysphonia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Dyspnoea | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 0/20 (0%) | 0 | 3/15 (20%) | 5 |
| Dyspnoea exertional | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 2/20 (10%) | 2 | 0/15 (0%) | 0 |
| Epistaxis | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Oropharyngeal pain | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 3/20 (15%) | 3 | 0/15 (0%) | 0 |
| Pleural effusion | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Decubitus ulcer | 1/3 (33.3%) | 1 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Dermatitis | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Dermatitis acneiform | 0/3 (0%) | 0 | 3/6 (50%) | 6 | 10/20 (50%) | 19 | 8/15 (53.3%) | 10 |
| Dermatitis contact | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Dry skin | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 2/15 (13.3%) | 2 |
| Palmar-plantar erythrodysaesthesia syndrome | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
| Pruritus | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 2/15 (13.3%) | 2 |
| Rash | 0/3 (0%) | 0 | 2/6 (33.3%) | 2 | 2/20 (10%) | 3 | 1/15 (6.7%) | 2 |
| Rash maculo-papular | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Skin fissures | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 4/20 (20%) | 6 | 3/15 (20%) | 3 |
| Stasis dermatitis | 0/3 (0%) | 0 | 0/6 (0%) | 0 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Urticaria | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 1/15 (6.7%) | 1 |
| Vascular disorders | ||||||||
| Flushing | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 3/15 (20%) | 3 |
| Hypotension | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 2/20 (10%) | 4 | 0/15 (0%) | 0 |
| Orthostatic hypotension | 0/3 (0%) | 0 | 1/6 (16.7%) | 1 | 0/20 (0%) | 0 | 0/15 (0%) | 0 |
Limitations/Caveats
Due to protocol amendment in Sep 2011,any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment June 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01099358
Other Study ID Numbers:
- 13418
- I4E-MC-JXBA
First Posted:
Apr 7, 2010
Last Update Posted:
Sep 26, 2019
Last Verified:
Sep 1, 2019