Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00757172
• Collaborator: National Cancer Institute (NCI) (NIH), Amgen (Industry)
• Enrollment: 70
• Locations: 21
• Arm: 1
• Duration (Months): 71
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to kill tumor cells or stop them from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with panitumumab and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving panitumumab together with docetaxel, cisplatin, radiation therapy, and surgery works in treating patients with newly diagnosed, locally advanced esophageal cancer or cancer of the gastroesophageal junction.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Gastroesophageal Junction; Esophageal Cancer	Biological: panitumumab; Drug: cisplatin; Drug: docetaxel; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery; Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

Primary

• To determine the pathologic complete response rate in patients with newly diagnosed, locally advanced adenocarcinoma of the distal esophagus or gastroesophageal junction treated with neoadjuvant panitumumab and combination chemoradiotherapy followed by surgery.

Secondary

• To determine the near-complete pathologic response rate in the primary tumor (≤ 10% residual viable cancer).

• To determine the overall survival and disease-free survival rates of these patients.

• To determine the safety profile of this regimen.

OUTLINE: Patients receive panitumumab IV over 1 hour, docetaxel IV over 1 hour, and cisplatin IV over 1-2 hours on day 1 in weeks 1, 3, 5, 7, and 9. Patients also undergo radiotherapy once daily 5 days a week beginning in week 5 and continuing for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 6-9 weeks after completion of chemoradiotherapy, patients with no evidence of metastatic disease undergo esophagectomy.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year OR every 6 months for 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Neoadjuvant Therapy With Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of the Distal Esophagus
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Docetaxel + Cisplatin + Panitumumab + RT Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).	Biological: panitumumab; Drug: cisplatin; Drug: docetaxel; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery; Radiation: radiation therapy

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Pathologic Complete Response Following Surgery [Post surgery]

   Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.

Secondary Outcome Measures

1. Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable) [Post surgery]

2. Percentage of Participants With 3-year Overall Survival [3 years]

   Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).

3. Percentage of Participants With 2-year Disease-free Survival [2 years]

   Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.

4. Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution [Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery]

   Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

1. ≥ 18 years old

2. ECOG/Zubrod Performance Status 0-1

3. Biopsy-proven resectable primary (nonrecurrent) adenocarcinoma of the distal esophagus or GE junction (Siewert Type I or II)

• Siewert Type I: adenocarcinoma of the distal esophagus

• Siewert Type II: adenocarcinoma of the esophago-gastric junction/real cardia

1. Pre-registration EUS, CT of chest and upper abdomen, and PET must support a clinical stage of T3N0M0, T2-3N1M0 or T2-3N0-1M1a (celiac adenopathy must be ≤ 2 cm by EUS). Clinically staged T1 tumors and T2N0M0 tumors are not eligible. N1 does not require biopsy/FNA. Note: Patients requiring a stent for nutrition must have staging examinations and scans completed before stent placement.

2. No definitive radiological evidence of distant metastases.

3. No pre-existing grade 2 or greater peripheral neuropathy (CTCAE v3) of any etiology.

4. Adequate bone marrow, hepatic and renal function prior to registration:

• WBC ≥ 3,000/mm³

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9.5 g/dL

• Creatinine ≤ 1.5 mg/dL

• Total bilirubin ≤ 3 mg/dL

• AST (SGOT) ≤ 2.0 times upper limit of normal (ULN)

• ALT (SGPT) ≤ 2.0 times ULN

• Alkaline phosphatase ≤ 2.0 times ULN

• Albumin ≥ 2.0 g/dL OR prealbumin ≥ 15 mg/dL

• Magnesium ≥ lower limit of normal (LLN)

1. Patient must be evaluated before registration by medical oncologist, radiation oncologist and surgeon and deemed fit for protocol therapy and surgery.

2. No prior invasive malignancy, unless disease-free for ≥ 5 years prior to registration (Exceptions: non-melanoma skin cancer, in-situ cancers).

3. Non-pregnant and non-breast feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic ≥ 12 months to be considered not of childbearing potential. All patients of reproductive potential must agree to use an an effective method of birth-control while receiving study therapy and for six months after completion of therapy.

4. No prior chest or upper abdomen radiotherapy; prior therapy with cisplatin, docetaxel, panitumumab or other anti-EGFR therapy or prior esophageal or gastric surgery (Exception: prior surgery to treat reflux disease)

5. No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psyschiatric illness/social situations that would limit compliance with study requirements.

6. No history of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan

7. No history of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
2	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois	United States	60611-3013
3	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
4	Evanston Hospital	Evanston	Illinois	United States	60201-1781
5	Simmons Cooper Cancer Institute	Springfield	Illinois	United States	62794-9677
6	Central Baptist Hospital	Lexington	Kentucky	United States	40503-9985
7	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
8	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
9	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Saint Louis	Missouri	United States	63110
10	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756-0002
11	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina	United States	28232-2861
12	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1096
13	Good Samaritan Hospital	Dayton	Ohio	United States	45406
14	Wayne Hospital	Greenville	Ohio	United States	45331
15	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
16	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
17	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon	United States	97227
18	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
19	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
20	UPMC Cancer Centers	Pittsburgh	Pennsylvania	United States	15232
21	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)
• Amgen

Investigators

• Study Chair: A. Craig Lockhart, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00757172
• Other Study ID Numbers: ACOSOG-Z4051; ACOSOG-Z4051; CDR0000596674; NCI-2009-00346; U10CA076001
• First Posted: Sep 23, 2008
• Last Update Posted: Mar 11, 2016
• Last Verified: Feb 1, 2016

• Keywords provided by Alliance for Clinical Trials in Oncology: adenocarcinoma of the esophagus; adenocarcinoma of the gastroesophageal junction; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer
• Additional relevant MeSH terms: Adenocarcinoma; Esophageal Neoplasms; Docetaxel; Panitumumab

Study Results

Participant Flow

Recruitment Details	Seventy participants were recruited between January 2009 to July 2011 from 24 institutions.
Pre-assignment Detail	Five participants were declared ineligible. One participant had a celiac lymph node >2 cm and one participant had two primary tumors. Liver lesions were noted and not investigated in one participant. Two participants had Siewert type III tumors. These five participants were excluded from all analysis except adverse events.

Arm/Group Title	Docetaxel + Cisplatin + Panitumumab + RT
Arm/Group Description	Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Period Title: Overall Study
STARTED	65
COMPLETED	54
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	Docetaxel + Cisplatin + Panitumumab + RT
Arm/Group Description	Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Overall Participants	65
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	61
Sex: Female, Male (Count of Participants)
Female	6 9.2%
Male	59 90.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 1.5%
White	64 98.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	65 100%
Eastern Cooperative Oncology Group (ECOG) performance status (participants) [Number]
0= Asymptomatic and fully active	37 56.9%
1= Symptomatic; fully ambulatory	28 43.1%
Body Mass Index (BMI) (kg/m^2) [Median (Full Range) ]
Median (Full Range) [kg/m^2]	27.8
Tumor location (Siewert Type) (participants) [Number]
I	36 55.4%
II	29 44.6%
Clinical T Stage (participants) [Number]
T2 = Tumor invades muscularis propria	7 10.8%
T3= Tumor invades adventitia	58 89.2%
Clinical N Stage (participants) [Number]
N0= No regional lymph node metastasis	13 20%
N1= Regional lymph node metastasis	52 80%
Clinical M Stage (participants) [Number]
M0= No distant metastasis	56 86.2%
M1a= Metastasis in celiac or cervical lymph nodes	9 13.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Pathologic Complete Response Following Surgery
Description	Pathologic complete response (pCR) was defined as no viable residual tumor cells. A cellular residual mucin pools should be noted but also considered a pathologic complete response.
Time Frame	Post surgery

Outcome Measure Data

Analysis Population Description

All participants who have met the eligibility criteria that have signed a consent form and began treatment.

Arm/Group Title	Docetaxel + Cisplatin + Panitumumab + RT
Arm/Group Description	Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Measure Participants	54
Number [participants]	18 27.7%

2. Secondary Outcome

Title	Number of Participants With Near-complete Response Rate (≤ 10% Residual Cancer in Primary Tumor Viable)
Time Frame	Post surgery

Outcome Measure Data

Analysis Population Description

All participants who have met the eligibility criteria that have signed a consent form and began treatment.

Arm/Group Title	Docetaxel + Cisplatin + Panitumumab + RT
Arm/Group Description	Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Measure Participants	54
Number [participants]	11 16.9%

3. Secondary Outcome

Title	Percentage of Participants With 3-year Overall Survival
Description	Survival time was defined to be the length of time from start of study therapy to death due to any cause or until last follow-up (censored value).
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

All registered participants who have met the eligibility criteria.

Arm/Group Title	Docetaxel + Cisplatin + Panitumumab + RT
Arm/Group Description	Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Measure Participants	65
Number [percentage of participants]	38.6 59.4%

4. Secondary Outcome

Title	Percentage of Participants With 2-year Disease-free Survival
Description	Disease-free survival was defined as the time from start of study therapy to documentation of disease recurrence. Participants who died without documentation of recurrence were considered to have had tumor recurrence at the time of death unless there was documented evidence that no recurrence occured before death. Participants who failed to return for evaluation after beginning therapy were censored for recurrence on the last day of therapy. Participants who experienced major treatment violations were censored for recurrence on the date the treatment violation occured.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

All registered participants who have met the eligibility criteria.

Arm/Group Title	Docetaxel + Cisplatin + Panitumumab + RT
Arm/Group Description	Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Measure Participants	65
Number [percentage of participants]	41.4 63.7%

5. Secondary Outcome

Title	Number of Participants With Frequent (>=15% Grade 3/4 Incidence) Adverse Events Regardless of Attribution
Description	Adverse events were assessed by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0. Grade 1= mild, grade 2= moderate, grade 3= severe, grade 4= life-threatening; and grade 5= death.
Time Frame	Week 1, 3, 5, 7, 9, 4-6 weeks after therapy and within 30 days post surgery

Outcome Measure Data

Analysis Population Description

All recruited participants.

Arm/Group Title	Docetaxel + Cisplatin + Panitumumab + RT
Arm/Group Description	Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
Measure Participants	70
Hemoglobin	12 18.5%
Lymphocytes	30 46.2%
Neutrophils	12 18.5%
Dehydration	13 20%
Esophagitis	13 20%
Nausea	11 16.9%

Adverse Events

Arm/Group Title	Docetaxel + Cisplatin + Panitumumab + RT
Arm/Group Description	Patients received docetaxel (40 mg/m^2), cisplatin (40 mg/m^2) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, and 9 with radiotherapy (RT) (5040 cGy, 180 cGy/day x 28 days) beginning week 5. Resection was planned after completing chemotherapy (CRT).
All Cause Mortality
	Docetaxel + Cisplatin + Panitumumab + RT
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Docetaxel + Cisplatin + Panitumumab + RT
	Affected / at Risk (%)	# Events
Total	46/70 (65.7%)
Blood and lymphatic system disorders
Febrile neutropenia	3/70 (4.3%)	3
Hemoglobin decreased	11/70 (15.7%)	12
Cardiac disorders
Atrial fibrillation	4/70 (5.7%)	5
Atrial flutter	1/70 (1.4%)	1
Sinus tachycardia	2/70 (2.9%)	2
Supraventricular tachycardia	1/70 (1.4%)	1
Gastrointestinal disorders
Abdominal pain	2/70 (2.9%)	3
Anal pain	1/70 (1.4%)	1
Constipation	1/70 (1.4%)	1
Diarrhea	4/70 (5.7%)	5
Dry mouth	1/70 (1.4%)	1
Dysphagia	4/70 (5.7%)	4
Ear, nose and throat examination abnormal	2/70 (2.9%)	2
Esophageal fistula	2/70 (2.9%)	2
Esophageal hemorrhage	1/70 (1.4%)	1
Esophageal pain	1/70 (1.4%)	1
Esophageal perforation	1/70 (1.4%)	1
Esophageal ulcer	1/70 (1.4%)	1
Esophagitis	7/70 (10%)	8
Gastrointestinal disorder	2/70 (2.9%)	2
Gastrointestinal pain	1/70 (1.4%)	1
Lower gastrointestinal hemorrhage	1/70 (1.4%)	1
Malabsorption	1/70 (1.4%)	1
Nausea	10/70 (14.3%)	11
Upper gastrointestinal hemorrhage	1/70 (1.4%)	1
Vomiting	9/70 (12.9%)	9
General disorders
Edema limbs	1/70 (1.4%)	1
Fatigue	2/70 (2.9%)	3
General symptom	1/70 (1.4%)	1
Multi-organ failure	1/70 (1.4%)	1
Infections and infestations
Catheter related infection	1/70 (1.4%)	1
Device related infection	1/70 (1.4%)	1
Endocarditis infective	1/70 (1.4%)	1
Infection	5/70 (7.1%)	5
Pleural infection	1/70 (1.4%)	1
Pneumonia	3/70 (4.3%)	3
Sepsis	1/70 (1.4%)	1
Skin infection	1/70 (1.4%)	1
Upper respiratory infection	2/70 (2.9%)	2
Urinary tract infection	2/70 (2.9%)	2
Wound infection	3/70 (4.3%)	3
Injury, poisoning and procedural complications
Esophageal anastomotic leak	2/70 (2.9%)	2
Gastrointestinal anastomotic leak	1/70 (1.4%)	1
Intraoperative gastrointestinal injury - Esophagus	1/70 (1.4%)	1
Vascular access complication	1/70 (1.4%)	1
Investigations
Activated partial thromboplastin time prolonged	3/70 (4.3%)	3
Alanine aminotransferase increased	1/70 (1.4%)	1
Aspartate aminotransferase increased	2/70 (2.9%)	2
Bilirubin increased	2/70 (2.9%)	2
Cardiac troponin I increased	1/70 (1.4%)	1
Creatinine increased	1/70 (1.4%)	1
INR increased	1/70 (1.4%)	1
Laboratory test abnormal	1/70 (1.4%)	3
Leukocyte count decreased	8/70 (11.4%)	9
Lymphocyte count decreased	15/70 (21.4%)	18
Neutrophil count decreased	6/70 (8.6%)	7
Platelet count decreased	2/70 (2.9%)	2
Weight loss	1/70 (1.4%)	1
Metabolism and nutrition disorders
Acidosis	2/70 (2.9%)	2
Alkalosis	2/70 (2.9%)	2
Anorexia	3/70 (4.3%)	4
Blood glucose increased	3/70 (4.3%)	3
Dehydration	10/70 (14.3%)	10
Serum albumin decreased	9/70 (12.9%)	10
Serum calcium decreased	5/70 (7.1%)	5
Serum magnesium decreased	2/70 (2.9%)	2
Serum phosphate decreased	4/70 (5.7%)	4
Serum potassium decreased	4/70 (5.7%)	5
Serum potassium increased	1/70 (1.4%)	1
Serum sodium decreased	3/70 (4.3%)	5
Serum sodium increased	1/70 (1.4%)	1
Musculoskeletal and connective tissue disorders
Muscle weakness	2/70 (2.9%)	3
Myalgia	1/70 (1.4%)	1
Nervous system disorders
Depressed level of consciousness	1/70 (1.4%)	1
Dizziness	1/70 (1.4%)	1
Encephalopathy	1/70 (1.4%)	1
Headache	1/70 (1.4%)	1
Ischemia cerebrovascular	1/70 (1.4%)	1
Peripheral sensory neuropathy	1/70 (1.4%)	1
Syncope	2/70 (2.9%)	2
Psychiatric disorders
Agitation	1/70 (1.4%)	1
Confusion	1/70 (1.4%)	1
Renal and urinary disorders
Renal failure	2/70 (2.9%)	2
Urogenital disorder	1/70 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome	2/70 (2.9%)	2
Chylothorax	2/70 (2.9%)	2
Cough	1/70 (1.4%)	1
Dyspnea	6/70 (8.6%)	6
Hypoxia	3/70 (4.3%)	3
Pleural effusion	5/70 (7.1%)	5
Pneumonitis	2/70 (2.9%)	2
Pneumothorax	1/70 (1.4%)	1
Respiratory disorder	3/70 (4.3%)	3
Skin and subcutaneous tissue disorders
Decubitus ulcer	1/70 (1.4%)	1
Rash acneiform	1/70 (1.4%)	1
Rash desquamating	2/70 (2.9%)	2
Vascular disorders
Hematoma	1/70 (1.4%)	1
Hypotension	3/70 (4.3%)	3
Thrombosis	10/70 (14.3%)	13
Visceral arterial ischemia	1/70 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Docetaxel + Cisplatin + Panitumumab + RT
	Affected / at Risk (%)	# Events
Total	70/70 (100%)
Blood and lymphatic system disorders
Febrile neutropenia	3/70 (4.3%)	3
Hemoglobin decreased	39/70 (55.7%)	139
Hemolysis	4/70 (5.7%)	4
Lymphatic disorder	1/70 (1.4%)	1
Cardiac disorders
Arrhythmia	2/70 (2.9%)	2
Arrhythmia supraventricular	1/70 (1.4%)	1
Atrial fibrillation	8/70 (11.4%)	8
Atrial tachycardia	2/70 (2.9%)	2
Cardiac disorder	2/70 (2.9%)	2
Conduction disorder	1/70 (1.4%)	1
Left ventricular failure	1/70 (1.4%)	1
Palpitations	2/70 (2.9%)	2
Pericardial effusion	1/70 (1.4%)	1
Premature ventricular contractions	1/70 (1.4%)	1
Sinus tachycardia	2/70 (2.9%)	2
Supraventricular tachycardia	1/70 (1.4%)	1
Ear and labyrinth disorders
Ear disorder	1/70 (1.4%)	1
Hearing loss	3/70 (4.3%)	12
Eye disorders
Diplopia	1/70 (1.4%)	1
Dry eye syndrome	1/70 (1.4%)	1
Eye disorder	1/70 (1.4%)	2
Eyelid function disorder	1/70 (1.4%)	1
Vision blurred	2/70 (2.9%)	2
Watering eyes	2/70 (2.9%)	4
Gastrointestinal disorders
Abdominal distension	2/70 (2.9%)	4
Abdominal pain	8/70 (11.4%)	14
Anal exam abnormal	2/70 (2.9%)	5
Ascites	1/70 (1.4%)	1
Cheilitis	1/70 (1.4%)	1
Constipation	18/70 (25.7%)	32
Diarrhea	37/70 (52.9%)	76
Dry mouth	1/70 (1.4%)	1
Dyspepsia	12/70 (17.1%)	27
Dysphagia	30/70 (42.9%)	49
Ear, nose and throat examination abnormal	13/70 (18.6%)	22
Esophageal pain	4/70 (5.7%)	7
Esophagitis	36/70 (51.4%)	77
Flatulence	1/70 (1.4%)	1
Gastrointestinal disorder	10/70 (14.3%)	18
Gingival pain	2/70 (2.9%)	4
Hemorrhoids	1/70 (1.4%)	1
Mucositis oral	8/70 (11.4%)	11
Nausea	49/70 (70%)	125
Oesophagoscopy abnormal	1/70 (1.4%)	1
Rectal hemorrhage	1/70 (1.4%)	1
Rectal pain	1/70 (1.4%)	1
Stomach pain	1/70 (1.4%)	2
Upper gastrointestinal hemorrhage	1/70 (1.4%)	1
Vomiting	28/70 (40%)	44
General disorders
Chest pain	3/70 (4.3%)	3
Chills	7/70 (10%)	10
Edema limbs	4/70 (5.7%)	6
Fatigue	50/70 (71.4%)	162
Fever	7/70 (10%)	10
General symptom	1/70 (1.4%)	1
Injection site reaction	2/70 (2.9%)	2
Localized edema	1/70 (1.4%)	1
Pain	11/70 (15.7%)	22
Immune system disorders
Cytokine release syndrome	1/70 (1.4%)	2
Hypersensitivity	13/70 (18.6%)	16
Infections and infestations
Bronchitis	1/70 (1.4%)	1
Catheter related infection	1/70 (1.4%)	1
Eye infection	2/70 (2.9%)	2
Infection	5/70 (7.1%)	7
Opportunistic infection	1/70 (1.4%)	1
Paranasal sinus infection	1/70 (1.4%)	1
Pleural infection	1/70 (1.4%)	1
Pneumonia	1/70 (1.4%)	1
Sepsis	3/70 (4.3%)	3
Skin infection	1/70 (1.4%)	1
Upper respiratory infection	1/70 (1.4%)	2
Urinary tract infection	1/70 (1.4%)	1
Wound infection	4/70 (5.7%)	4
Injury, poisoning and procedural complications
Bruising	1/70 (1.4%)	1
Dermatitis radiation	9/70 (12.9%)	14
Esophageal anastomotic leak	1/70 (1.4%)	1
Thermal burn	1/70 (1.4%)	2
Investigations
Activated partial thromboplastin time prolonged	1/70 (1.4%)	1
Alanine aminotransferase increased	17/70 (24.3%)	24
Alkaline phosphatase increased	10/70 (14.3%)	20
Aspartate aminotransferase increased	19/70 (27.1%)	25
Bilirubin increased	8/70 (11.4%)	12
Creatinine increased	15/70 (21.4%)	21
INR increased	2/70 (2.9%)	2
Laboratory test abnormal	3/70 (4.3%)	22
Leukocyte count decreased	56/70 (80%)	156
Lymphocyte count decreased	29/70 (41.4%)	79
Neutrophil count decreased	18/70 (25.7%)	30
Platelet count decreased	40/70 (57.1%)	91
Weight gain	1/70 (1.4%)	1
Weight loss	19/70 (27.1%)	30
Metabolism and nutrition disorders
Anorexia	30/70 (42.9%)	67
Blood bicarbonate decreased	2/70 (2.9%)	3
Blood glucose increased	30/70 (42.9%)	73
Blood uric acid increased	1/70 (1.4%)	1
Dehydration	20/70 (28.6%)	29
Serum albumin decreased	28/70 (40%)	85
Serum calcium decreased	23/70 (32.9%)	49
Serum calcium increased	1/70 (1.4%)	1
Serum glucose decreased	2/70 (2.9%)	3
Serum magnesium decreased	36/70 (51.4%)	90
Serum magnesium increased	8/70 (11.4%)	9
Serum phosphate decreased	9/70 (12.9%)	17
Serum potassium decreased	18/70 (25.7%)	31
Serum potassium increased	10/70 (14.3%)	12
Serum sodium decreased	16/70 (22.9%)	35
Serum sodium increased	7/70 (10%)	7
Musculoskeletal and connective tissue disorders
Arthritis	1/70 (1.4%)	4
Back pain	5/70 (7.1%)	11
Joint pain	3/70 (4.3%)	3
Muscle weakness	6/70 (8.6%)	6
Muscle weakness lower limb	1/70 (1.4%)	1
Myalgia	17/70 (24.3%)	22
Myositis	1/70 (1.4%)	1
Nervous system disorders
Dizziness	16/70 (22.9%)	28
Headache	3/70 (4.3%)	4
Neurological disorder NOS	3/70 (4.3%)	4
Peripheral motor neuropathy	1/70 (1.4%)	1
Peripheral sensory neuropathy	22/70 (31.4%)	56
Recurrent laryngeal nerve palsy	1/70 (1.4%)	1
Seizure	1/70 (1.4%)	1
Syncope	1/70 (1.4%)	1
Taste alteration	13/70 (18.6%)	36
Tremor	2/70 (2.9%)	3
Psychiatric disorders
Agitation	2/70 (2.9%)	3
Anxiety	10/70 (14.3%)	37
Confusion	2/70 (2.9%)	2
Depression	3/70 (4.3%)	8
Insomnia	11/70 (15.7%)	38
Renal and urinary disorders
Hemorrhage urinary tract	1/70 (1.4%)	1
Protein urine positive	4/70 (5.7%)	4
Urinary frequency	1/70 (1.4%)	1
Urinary retention	3/70 (4.3%)	3
Reproductive system and breast disorders
Penile pain	1/70 (1.4%)	1
Vaginal dryness	1/70 (1.4%)	2
Vaginal mucositis	1/70 (1.4%)	4
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis	1/70 (1.4%)	1
Atelectasis	4/70 (5.7%)	4
Bronchospasm	1/70 (1.4%)	1
Chylothorax	1/70 (1.4%)	1
Cough	20/70 (28.6%)	41
Dyspnea	16/70 (22.9%)	30
Epistaxis	1/70 (1.4%)	2
Hemorrhage nasal	6/70 (8.6%)	12
Hiccough	1/70 (1.4%)	1
Hypoxia	1/70 (1.4%)	1
Nasal congestion	1/70 (1.4%)	1
Pharyngolaryngeal pain	3/70 (4.3%)	3
Pleural effusion	17/70 (24.3%)	17
Pneumonitis	3/70 (4.3%)	3
Pneumothorax	4/70 (5.7%)	4
Respiratory disorder	4/70 (5.7%)	14
Voice alteration	4/70 (5.7%)	4
Skin and subcutaneous tissue disorders
Alopecia	19/70 (27.1%)	49
Dry skin	8/70 (11.4%)	22
Hand-and-foot syndrome	1/70 (1.4%)	1
Nail disorder	1/70 (1.4%)	1
Pain of skin	1/70 (1.4%)	1
Pruritus	33/70 (47.1%)	82
Rash acneiform	66/70 (94.3%)	279
Rash desquamating	26/70 (37.1%)	60
Skin disorder	2/70 (2.9%)	2
Skin hyperpigmentation	1/70 (1.4%)	1
Sweating	1/70 (1.4%)	1
Urticaria	1/70 (1.4%)	1
Vascular disorders
Flushing	2/70 (2.9%)	2
Hot flashes	1/70 (1.4%)	3
Hypertension	3/70 (4.3%)	3
Hypotension	11/70 (15.7%)	15
Phlebitis	2/70 (2.9%)	3
Thrombosis	1/70 (1.4%)	1
Vascular disorder	1/70 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.