Trial Outcomes & Findings for Panitumumab, Chemotherapy, and External-Beam Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot be Removed by Surgery (NCT NCT00601627)
NCT ID: NCT00601627
Last Updated: 2017-04-05
Results Overview
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the exact binomial method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2017-04-05
Participant Flow
Participant milestones
| Measure |
Panitumumab
Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m\^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m\^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Panitumumab, Chemotherapy, and External-Beam Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Panitumumab
n=51 Participants
Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m\^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m\^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: All patients were evaluable for this endpoint.
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the exact binomial method.
Outcome measures
| Measure |
Panitumumab
n=51 Participants
Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m\^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m\^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
|
|---|---|
|
One Year Survival Rate
|
0.502 proportion of patients
Interval 0.354 to 0.632
|
SECONDARY outcome
Timeframe: baseline to 2 yearsPopulation: All patients were evaluable for this endpoint.
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier
Outcome measures
| Measure |
Panitumumab
n=51 Participants
Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m\^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m\^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
|
|---|---|
|
Overall Survival
|
12.1 months
Interval 6.8 to 15.1
|
SECONDARY outcome
Timeframe: baseline to 2 yearsPopulation: All patients were evaluable for this endpoint.
Progression Free Survival is defined as the time from registration to the earliest documented evidence of disease progression.
Outcome measures
| Measure |
Panitumumab
n=51 Participants
Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m\^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m\^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
|
|---|---|
|
Progression Free Survival (PFS)
|
7.4 months
Interval 3.7 to 8.6
|
SECONDARY outcome
Timeframe: baseline to 2 yearsPopulation: All patients were analyzed for this endpoint.
A confirmed tumor response is defined to be a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. A complete response is defined as the disappearance of all target and non-target lesions. A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of the target lesion from baseline. Confirmed tumor response will be evaluated using the first 6 cycles of treatment.
Outcome measures
| Measure |
Panitumumab
n=51 Participants
Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m\^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m\^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
|
|---|---|
|
Confirmed Response Rate
|
0.059 rate of confirmed response
Interval 0.012 to 0.162
|
SECONDARY outcome
Timeframe: baseline to 2 yearsPopulation: Too few patients reported a confirmed response to provide meaningful information into the duration of response.
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 2 yearsPopulation: All patients were included in the analysis.
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Panitumumab
n=51 Participants
Chemotherapy concurrent with radiation:
Radiation 5 days per week for 5½ weeks; 6 mg/kg Panitumumab on days 1, 15, and 29 of radiation therapy 225 mg/m\^2 per day 5-fluorouracil (5FU) continuous infusion, starting on day 1 and through last day of radiation.
4-6 weeks after completion of radiation therapy: 1000 mg/m\^2 Gemcitabine on days 1, 8, and 15 of each cycle, for 3 cycles; 6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 3 cycles.
Maintenance therapy:
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
|
|---|---|
|
Time to Treatment Failure
|
2.71 months
Interval 1.54 to 4.24
|
Adverse Events
Panitumumab
Serious events: 29 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panitumumab
n=51 participants at risk
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
13.7%
7/51 • Number of events 8
|
|
Gastrointestinal disorders
Duodenal obstruction
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal ulcer
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
5.9%
3/51 • Number of events 4
|
|
Gastrointestinal disorders
Esophageal stenosis
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal ulcer
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
17.6%
9/51 • Number of events 10
|
|
Gastrointestinal disorders
Small intestine ulcer
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
13.7%
7/51 • Number of events 8
|
|
General disorders
Chest pain
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Death
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Fatigue
|
13.7%
7/51 • Number of events 8
|
|
General disorders
Fever
|
3.9%
2/51 • Number of events 2
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/51 • Number of events 1
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Biliary tract infection
|
3.9%
2/51 • Number of events 2
|
|
Infections and infestations
Bladder infection
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.0%
1/51 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
2.0%
1/51 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
5.9%
3/51 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
1/51 • Number of events 1
|
|
Investigations
Bilirubin increased
|
5.9%
3/51 • Number of events 5
|
|
Investigations
Creatinine increased
|
2.0%
1/51 • Number of events 1
|
|
Investigations
INR increased
|
2.0%
1/51 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
2.0%
1/51 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
7.8%
4/51 • Number of events 5
|
|
Investigations
Neutrophil count decreased
|
3.9%
2/51 • Number of events 2
|
|
Investigations
Platelet count decreased
|
2.0%
1/51 • Number of events 1
|
|
Investigations
Weight loss
|
7.8%
4/51 • Number of events 5
|
|
Metabolism and nutrition disorders
Anorexia
|
7.8%
4/51 • Number of events 5
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
3.9%
2/51 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
21.6%
11/51 • Number of events 11
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
3.9%
2/51 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
2.0%
1/51 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
3.9%
2/51 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.0%
1/51 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
2.0%
1/51 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.0%
1/51 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
3.9%
2/51 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.0%
1/51 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/51 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
3.9%
2/51 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.9%
2/51 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/51 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/51 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
2.0%
1/51 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/51 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.9%
2/51 • Number of events 2
|
|
Vascular disorders
Hypotension
|
3.9%
2/51 • Number of events 2
|
|
Vascular disorders
Thrombosis
|
7.8%
4/51 • Number of events 4
|
Other adverse events
| Measure |
Panitumumab
n=51 participants at risk
6 mg/kg Panitumumab on days 1 and 15 of each cycle, for 6 cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
80.4%
41/51 • Number of events 126
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
21.6%
11/51 • Number of events 16
|
|
Gastrointestinal disorders
Ascites
|
7.8%
4/51 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
9.8%
5/51 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhea
|
58.8%
30/51 • Number of events 64
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
41.2%
21/51 • Number of events 33
|
|
Gastrointestinal disorders
Flatulence
|
3.9%
2/51 • Number of events 2
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
31.4%
16/51 • Number of events 23
|
|
Gastrointestinal disorders
Nausea
|
78.4%
40/51 • Number of events 83
|
|
Gastrointestinal disorders
Stomach pain
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.0%
1/51 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
60.8%
31/51 • Number of events 52
|
|
General disorders
Chest pain
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Disease progression
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Edema limbs
|
7.8%
4/51 • Number of events 4
|
|
General disorders
Facial pain
|
2.0%
1/51 • Number of events 1
|
|
General disorders
Fatigue
|
92.2%
47/51 • Number of events 137
|
|
General disorders
Fever
|
13.7%
7/51 • Number of events 7
|
|
Infections and infestations
Abdominal infection
|
5.9%
3/51 • Number of events 8
|
|
Infections and infestations
Catheter related infection
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Esophageal infection
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Infection
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Infectious colitis
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Opportunistic infection
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Otitis externa
|
2.0%
1/51 • Number of events 1
|
|
Infections and infestations
Skin infection
|
2.0%
1/51 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.0%
1/51 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
9.8%
5/51 • Number of events 7
|
|
Investigations
Alkaline phosphatase increased
|
9.8%
5/51 • Number of events 8
|
|
Investigations
Aspartate aminotransferase increased
|
15.7%
8/51 • Number of events 10
|
|
Investigations
Bilirubin increased
|
9.8%
5/51 • Number of events 6
|
|
Investigations
Creatinine increased
|
9.8%
5/51 • Number of events 7
|
|
Investigations
INR increased
|
2.0%
1/51 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
62.7%
32/51 • Number of events 79
|
|
Investigations
Lymphocyte count decreased
|
19.6%
10/51 • Number of events 17
|
|
Investigations
Neutrophil count decreased
|
37.3%
19/51 • Number of events 36
|
|
Investigations
Platelet count decreased
|
54.9%
28/51 • Number of events 63
|
|
Investigations
Weight loss
|
17.6%
9/51 • Number of events 13
|
|
Metabolism and nutrition disorders
Anorexia
|
84.3%
43/51 • Number of events 86
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
2.0%
1/51 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
13.7%
7/51 • Number of events 9
|
|
Metabolism and nutrition disorders
Dehydration
|
17.6%
9/51 • Number of events 13
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
11.8%
6/51 • Number of events 8
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
13.7%
7/51 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
56.9%
29/51 • Number of events 87
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
3.9%
2/51 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
7.8%
4/51 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
2.0%
1/51 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
5.9%
3/51 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
4/51 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
7.8%
4/51 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/51 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/51 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
2.0%
1/51 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
3.9%
2/51 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.0%
1/51 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
3/51 • Number of events 4
|
|
Nervous system disorders
Taste alteration
|
7.8%
4/51 • Number of events 8
|
|
Psychiatric disorders
Depression
|
3.9%
2/51 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/51 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.5%
14/51 • Number of events 27
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
31.4%
16/51 • Number of events 29
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
5.9%
3/51 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.9%
2/51 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.8%
4/51 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
11.8%
6/51 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
5.9%
3/51 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
15.7%
8/51 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
2.0%
1/51 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
43.1%
22/51 • Number of events 57
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
68.6%
35/51 • Number of events 84
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
41.2%
21/51 • Number of events 43
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.0%
1/51 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
7.8%
4/51 • Number of events 5
|
|
Vascular disorders
Hot flashes
|
2.0%
1/51 • Number of events 2
|
|
Vascular disorders
Hypertension
|
2.0%
1/51 • Number of events 1
|
|
Vascular disorders
Hypotension
|
5.9%
3/51 • Number of events 5
|
|
Vascular disorders
Thrombosis
|
2.0%
1/51 • Number of events 1
|
Additional Information
George P. Kim, M.D.
Alliance for Clinical Trials in Oncology
Phone: 507-284-4918
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60