Trial Outcomes & Findings for Phase II Study of Irinotecan and Panitumumab (NCT NCT00836277)
NCT ID: NCT00836277
Last Updated: 2016-11-15
Results Overview
Response rate (RR) = the # participants with partial response (PR) + # participants with (CR) / # participants with (PR) + # participants with (CR ) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
COMPLETED
PHASE2
24 participants
Up to 14 months
2016-11-15
Participant Flow
Participant milestones
| Measure |
Irinotecan + Panitumumab
Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m\^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Irinotecan + Panitumumab
Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m\^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
|
|---|---|
|
Overall Study
Not evaluable for response
|
6
|
Baseline Characteristics
Phase II Study of Irinotecan and Panitumumab
Baseline characteristics by cohort
| Measure |
Irinotecan + Panitumumab
n=18 Participants
Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m\^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
|
|---|---|
|
Age, Continuous
|
62.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 14 monthsResponse rate (RR) = the # participants with partial response (PR) + # participants with (CR) / # participants with (PR) + # participants with (CR ) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions was used: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Outcome measures
| Measure |
Irinotecan + Panitumumab
n=18 Participants
Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m\^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
|
|---|---|
|
Response Rate (RR)
|
6 percentage of participants
Interval 1.0 to 26.0
|
PRIMARY outcome
Timeframe: Up to 14 monthsUsing RECIST v1.0 criteria, clinical benefit rate (CBR) = # participants with (PR) + # participants with (CR) + # participants with (SD) / # participants with (PR) + # participants with (CR) + # participants with (SD) + # participants with (PD). This proportion was subsequently multiplied by 100. RECIST v1.0 criteria for Target Lesions is defined as: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Irinotecan + Panitumumab
n=18 Participants
Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m\^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
|
|---|---|
|
Clinical Benefit Rate (CBR)
|
50 percentage of participants
Interval 29.0 to 71.0
|
SECONDARY outcome
Timeframe: Up to 45 months (cohort)Survival time the is free of disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Irinotecan + Panitumumab
n=18 Participants
Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m\^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
|
|---|---|
|
Progression-free Survival (PFS)
|
2.9 months
Interval 1.6 to 5.3
|
SECONDARY outcome
Timeframe: Up to 45 months (cohort)Outcome measures
| Measure |
Irinotecan + Panitumumab
n=18 Participants
Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m\^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
|
|---|---|
|
Overall Survival (OS)
|
7.2 months
Interval 4.1 to 8.9
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Irinotecan + Panitumumab
n=18 Participants
Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m\^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
|
|---|---|
|
1-year (Overall) Survival Rate
|
11.1 percentage of participants
|
Adverse Events
Irinotecan + Panitumumab
Serious adverse events
| Measure |
Irinotecan + Panitumumab
n=18 participants at risk
Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m\^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
5.6%
1/18
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
11.1%
2/18
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
5.6%
1/18
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
11.1%
2/18
|
|
General disorders
Weight loss
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
5.6%
1/18
|
|
Gastrointestinal disorders
Dehydration
|
16.7%
3/18
|
|
Gastrointestinal disorders
Diarrhea
|
27.8%
5/18
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
5.6%
1/18
|
|
Gastrointestinal disorders
Perforation, GI, Small bowel NOS
|
5.6%
1/18
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
3/18
|
|
Infections and infestations
Infection with unknown ANC, Catheter-related
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
5.6%
1/18
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
5.6%
1/18
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
5.6%
1/18
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.6%
1/18
|
Other adverse events
| Measure |
Irinotecan + Panitumumab
n=18 participants at risk
Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m\^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
|
|---|---|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
11.1%
2/18
|
|
Gastrointestinal disorders
Anorexia
|
27.8%
5/18
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
27.8%
5/18
|
|
Gastrointestinal disorders
Diarrhea
|
44.4%
8/18
|
|
Gastrointestinal disorders
Nausea
|
50.0%
9/18
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory, Nose
|
5.6%
1/18
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)
|
5.6%
1/18
|
|
Infections and infestations
Infection with unknown ANC, Catheter-related
|
5.6%
1/18
|
|
Infections and infestations
Infection with unknown ANC, Mucosa
|
5.6%
1/18
|
|
Blood and lymphatic system disorders
Edema: limb
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other (Specify, __)
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
16.7%
3/18
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
16.7%
3/18
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
33.3%
6/18
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
33.3%
6/18
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
38.9%
7/18
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
38.9%
7/18
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
44.4%
8/18
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
50.0%
9/18
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
61.1%
11/18
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
72.2%
13/18
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Extremity-lower
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other (Specify, __)
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy), Whole body/generalized
|
16.7%
3/18
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18
|
|
Nervous system disorders
Syncope (fainting)
|
5.6%
1/18
|
|
Nervous system disorders
Mood alteration, Anxiety
|
16.7%
3/18
|
|
Nervous system disorders
Mood alteration, Depression
|
16.7%
3/18
|
|
Nervous system disorders
Neuropathy: sensory
|
27.8%
5/18
|
|
Eye disorders
Eyelid dysfunction
|
5.6%
1/18
|
|
General disorders
Pain, Esophagus
|
5.6%
1/18
|
|
General disorders
Pain, Extremity-limb
|
5.6%
1/18
|
|
General disorders
Pain, Head/headache
|
5.6%
1/18
|
|
General disorders
Pain, Oral-gums
|
5.6%
1/18
|
|
Blood and lymphatic system disorders
INR (International Normalized Ratio of prothrombin time)
|
5.6%
1/18
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
5.6%
1/18
|
|
General disorders
Insomnia
|
16.7%
3/18
|
|
Skin and subcutaneous tissue disorders
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Flushing
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation, Chemoradiation
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
3/18
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
66.7%
12/18
|
|
Gastrointestinal disorders
Dehydration
|
5.6%
1/18
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
5.6%
1/18
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.6%
1/18
|
|
Gastrointestinal disorders
Stricture/stenosis (including anastomotic), GI, Esophagus
|
5.6%
1/18
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18
|
|
Gastrointestinal disorders
Constipation
|
11.1%
2/18
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
5.6%
1/18
|
|
Blood and lymphatic system disorders
Lymphopenia
|
27.8%
5/18
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
55.6%
10/18
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
72.2%
13/18
|
|
Blood and lymphatic system disorders
Hemoglobin
|
83.3%
15/18
|
|
Cardiac disorders
Cardiac General - Other (Specify, __)
|
11.1%
2/18
|
|
Cardiac disorders
Hypertension
|
16.7%
3/18
|
|
Cardiac disorders
Hypotension
|
22.2%
4/18
|
|
General disorders
Pain, Throat/pharynx/larynx
|
5.6%
1/18
|
|
General disorders
Pain, Tumor pain
|
5.6%
1/18
|
|
General disorders
Pain, Bone
|
11.1%
2/18
|
|
General disorders
Pain, Abdomen NOS
|
27.8%
5/18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
11.1%
2/18
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.6%
1/18
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
5.6%
1/18
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.6%
1/18
|
Additional Information
Weijing Sun, MD
University of Pittsburgh Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place