Trial Outcomes & Findings for Erlotinib and Gemcitabine With or Without Panitumumab in Treating Patients With Metastatic Pancreatic Cancer (NCT NCT00550836)
NCT ID: NCT00550836
Last Updated: 2017-04-05
Results Overview
Overall Survival is defined as the time from registration to death due to any cause. The estimate will be done using the Kaplan-Meier method. The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A). The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2017-04-05
Participant Flow
Participant milestones
| Measure |
Arm A: GE
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Arm B: PGE
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
55
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
Reasons for withdrawal
| Measure |
Arm A: GE
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Arm B: PGE
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
9
|
Baseline Characteristics
Erlotinib and Gemcitabine With or Without Panitumumab in Treating Patients With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Arm A: GE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Arm B: PGE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
n=5 Participants
|
62 years
n=7 Participants
|
61.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
46 participants
n=7 Participants
|
92 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All treated patients that were eligible were included in the analysis.
Overall Survival is defined as the time from registration to death due to any cause. The estimate will be done using the Kaplan-Meier method. The primary goal of this trial is to compare the experimental arm (Arm B) to the standard arm (Arm A). The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves.
Outcome measures
| Measure |
Arm A: GE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Arm B: PGE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
|---|---|---|
|
Overall Survival
|
4.2 months
Interval 3.5 to 7.8
|
8.3 months
Interval 4.5 to 10.0
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All patients that started protocol treatment and were evaluated were included in this analysis.
Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
Outcome measures
| Measure |
Arm A: GE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Arm B: PGE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
|---|---|---|
|
Confirmed Response Rate
|
0.087 rate of confirmed response
Interval 0.024 to 0.208
|
0.065 rate of confirmed response
Interval 0.014 to 0.179
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All treated patients were included in this analysis.
Progression-free survival is defined as the time from randomization to documentation of disease progression or death, whichever comes first. Progression is defined as at least a 20% increase in the sum of longest dimension (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. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. The progression-free survival curves will be compared between the 2 arms using a log-rank test.
Outcome measures
| Measure |
Arm A: GE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Arm B: PGE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
|---|---|---|
|
Progression-free Survival
|
2.0 months
Interval 1.8 to 3.3
|
3.6 months
Interval 2.3 to 4.5
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All eligible treated patients were included in this analysis.
Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a nonprotocol failure, the patient will be censored on the date they are removed from treatment. The time to treatment failure will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A: GE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Arm B: PGE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
|---|---|---|
|
Time to Treatment Failure
|
2.0 months
Interval 1.8 to 2.5
|
3.8 months
Interval 2.0 to 4.2
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All evaluable patients were included in this analysis.
Patients are assessed for Adverse events each cycle using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0). The maximum grade for each type of adverse event will be recorded for each patient, and tables will be reviewed to determine adverse event patterns. The number of patients in each arm that reported a grade 3 or higher adverse event and a grade 4 or higher adverse event are reported. A complete listing of all adverse events is reported in the Adverse Events section.
Outcome measures
| Measure |
Arm A: GE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Arm B: PGE
n=46 Participants
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
|---|---|---|
|
Frequency and Severity of Observed Adverse Effects
Grade 4+ Adverse Event
|
15 participants
|
14 participants
|
|
Frequency and Severity of Observed Adverse Effects
Grade 3+ Adverse Event
|
41 participants
|
41 participants
|
Adverse Events
Arm A: GE
Serious events: 30 serious events
Other events: 45 other events
Deaths: 0 deaths
Arm B: PGE
Serious events: 27 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: GE
n=46 participants at risk
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Arm B: PGE
n=46 participants at risk
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
13.0%
6/46 • Number of events 6
|
13.0%
6/46 • Number of events 6
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
15.2%
7/46 • Number of events 7
|
4.3%
2/46 • Number of events 2
|
|
Gastrointestinal disorders
Ascites
|
4.3%
2/46 • Number of events 2
|
0.00%
0/46
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
2/46 • Number of events 3
|
4.3%
2/46 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.00%
0/46
|
4.3%
2/46 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Enteritis
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Ileus
|
4.3%
2/46 • Number of events 2
|
0.00%
0/46
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Jejunal obstruction
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
21.7%
10/46 • Number of events 10
|
6.5%
3/46 • Number of events 4
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal perforation
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Vomiting
|
19.6%
9/46 • Number of events 9
|
8.7%
4/46 • Number of events 4
|
|
General disorders
Chest pain
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
General disorders
Death
|
0.00%
0/46
|
4.3%
2/46 • Number of events 2
|
|
General disorders
Disease progression
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
General disorders
Edema limbs
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
General disorders
Fatigue
|
10.9%
5/46 • Number of events 5
|
8.7%
4/46 • Number of events 4
|
|
General disorders
Fever
|
4.3%
2/46 • Number of events 2
|
4.3%
2/46 • Number of events 2
|
|
General disorders
Pain
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/46
|
4.3%
2/46 • Number of events 2
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Infections and infestations
Catheter related infection
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Infections and infestations
Gallbladder infection
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/46
|
4.3%
2/46 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Infections and infestations
Sepsis
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Infections and infestations
Skin infection
|
4.3%
2/46 • Number of events 2
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
6.5%
3/46 • Number of events 4
|
4.3%
2/46 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/46
|
4.3%
2/46 • Number of events 2
|
|
Investigations
Bilirubin increased
|
8.7%
4/46 • Number of events 4
|
6.5%
3/46 • Number of events 3
|
|
Investigations
Creatinine increased
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Investigations
Lipase increased
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Platelet count decreased
|
6.5%
3/46 • Number of events 3
|
4.3%
2/46 • Number of events 2
|
|
Investigations
Weight loss
|
4.3%
2/46 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
8.7%
4/46 • Number of events 4
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
6.5%
3/46 • Number of events 3
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
3/46 • Number of events 4
|
4.3%
2/46 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
2.2%
1/46 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
2.2%
1/46 • Number of events 1
|
6.5%
3/46 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
3/46 • Number of events 4
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.3%
2/46 • Number of events 2
|
2.2%
1/46 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Ischemia cerebrovascular
|
2.2%
1/46 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
|
Nervous system disorders
Syncope
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
4.3%
2/46 • Number of events 2
|
0.00%
0/46
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Psychiatric disorders
Psychosis
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Renal and urinary disorders
Renal failure
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
3/46 • Number of events 3
|
8.7%
4/46 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/46 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/46
|
4.3%
2/46 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/46
|
4.3%
2/46 • Number of events 2
|
|
Vascular disorders
Hypotension
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
19.6%
9/46 • Number of events 9
|
13.0%
6/46 • Number of events 6
|
Other adverse events
| Measure |
Arm A: GE
n=46 participants at risk
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; and 100 mg oral erlotinib hydrochloride on days 1-28. Treatment repeats every 28 days for 2 courses. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses of treatment; patients achieving a partial response (PR) receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride and erlotinib hydrochloride until second progression.
|
Arm B: PGE
n=46 participants at risk
Patients receive 1000 mg/m\^2 gemcitabine hydrochloride IV on days 1, 8, and 15; 100 mg oral erlotinib hydrochloride on days 1 - 28; and 4.0 mg/kg panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 2 courses. Patients achieving a CR after 2 courses receive 2 additional courses of treatment; patients achieving a PR receive retreatment as above. Patients achieving a CR after 4 courses of treatment receive erlotinib hydrochloride and panitumumab until the first disease progression. After the first progression, patients are retreated with gemcitabine hydrochloride, erlotinib hydrochloride, and panitumumab until second progression.
|
|---|---|---|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
8.7%
4/46 • Number of events 7
|
6.5%
3/46 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • Number of events 2
|
6.5%
3/46 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.2%
1/46 • Number of events 2
|
0.00%
0/46
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
17.4%
8/46 • Number of events 11
|
21.7%
10/46 • Number of events 21
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
4/46 • Number of events 8
|
10.9%
5/46 • Number of events 6
|
|
Gastrointestinal disorders
Ascites
|
2.2%
1/46 • Number of events 1
|
8.7%
4/46 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
10.9%
5/46 • Number of events 13
|
2.2%
1/46 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
54.3%
25/46 • Number of events 47
|
52.2%
24/46 • Number of events 60
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
4.3%
2/46 • Number of events 2
|
0.00%
0/46
|
|
Gastrointestinal disorders
Flatulence
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Nausea
|
65.2%
30/46 • Number of events 64
|
76.1%
35/46 • Number of events 79
|
|
Gastrointestinal disorders
Pancreatitis
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Gastrointestinal disorders
Vomiting
|
28.3%
13/46 • Number of events 21
|
47.8%
22/46 • Number of events 32
|
|
General disorders
Chest pain
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
General disorders
Edema limbs
|
2.2%
1/46 • Number of events 1
|
8.7%
4/46 • Number of events 7
|
|
General disorders
Fatigue
|
32.6%
15/46 • Number of events 25
|
41.3%
19/46 • Number of events 44
|
|
General disorders
Fever
|
2.2%
1/46 • Number of events 1
|
6.5%
3/46 • Number of events 3
|
|
General disorders
Pain
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Immune system disorders
Hypersensitivity
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Infections and infestations
Biliary tract infection
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Infections and infestations
Gingival infection
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Infections and infestations
Infection
|
0.00%
0/46
|
2.2%
1/46 • Number of events 3
|
|
Infections and infestations
Nail infection
|
0.00%
0/46
|
2.2%
1/46 • Number of events 2
|
|
Infections and infestations
Paranasal sinus infection
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Infections and infestations
Sinusitis
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Infections and infestations
Skin infection
|
2.2%
1/46 • Number of events 1
|
8.7%
4/46 • Number of events 4
|
|
Infections and infestations
Vaginal infection
|
2.2%
1/46 • Number of events 2
|
0.00%
0/46
|
|
Injury, poisoning and procedural complications
Venous injury - Extremity-upper
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
21.7%
10/46 • Number of events 12
|
15.2%
7/46 • Number of events 13
|
|
Investigations
Alkaline phosphatase increased
|
23.9%
11/46 • Number of events 15
|
21.7%
10/46 • Number of events 12
|
|
Investigations
Aspartate aminotransferase increased
|
10.9%
5/46 • Number of events 5
|
21.7%
10/46 • Number of events 10
|
|
Investigations
Bilirubin increased
|
6.5%
3/46 • Number of events 3
|
10.9%
5/46 • Number of events 6
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Coagulopathy
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Investigations
Creatinine increased
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Investigations
INR increased
|
0.00%
0/46
|
2.2%
1/46 • Number of events 2
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/46
|
4.3%
2/46 • Number of events 2
|
|
Investigations
Leukocyte count decreased
|
15.2%
7/46 • Number of events 13
|
10.9%
5/46 • Number of events 7
|
|
Investigations
Lipase increased
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Investigations
Lymphocyte count decreased
|
8.7%
4/46 • Number of events 5
|
4.3%
2/46 • Number of events 9
|
|
Investigations
Neutrophil count decreased
|
54.3%
25/46 • Number of events 69
|
45.7%
21/46 • Number of events 45
|
|
Investigations
Platelet count decreased
|
69.6%
32/46 • Number of events 95
|
63.0%
29/46 • Number of events 73
|
|
Investigations
Weight loss
|
8.7%
4/46 • Number of events 7
|
10.9%
5/46 • Number of events 12
|
|
Metabolism and nutrition disorders
Anorexia
|
26.1%
12/46 • Number of events 16
|
37.0%
17/46 • Number of events 30
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
6.5%
3/46 • Number of events 3
|
15.2%
7/46 • Number of events 9
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/46
|
8.7%
4/46 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
4.3%
2/46 • Number of events 2
|
21.7%
10/46 • Number of events 17
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
2.2%
1/46 • Number of events 1
|
15.2%
7/46 • Number of events 13
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
10.9%
5/46 • Number of events 8
|
67.4%
31/46 • Number of events 102
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
2.2%
1/46 • Number of events 1
|
4.3%
2/46 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/46
|
8.7%
4/46 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/46
|
8.7%
4/46 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Nervous system disorders
Mini mental status examination abnormal
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Nervous system disorders
Taste alteration
|
6.5%
3/46 • Number of events 3
|
6.5%
3/46 • Number of events 5
|
|
Psychiatric disorders
Confusion
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/46
|
4.3%
2/46 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.1%
12/46 • Number of events 22
|
26.1%
12/46 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.7%
10/46 • Number of events 19
|
30.4%
14/46 • Number of events 25
|
|
Respiratory, thoracic and mediastinal disorders
Hiccough
|
0.00%
0/46
|
2.2%
1/46 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/46
|
4.3%
2/46 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
|
0.00%
0/46
|
2.2%
1/46 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
1/46 • Number of events 1
|
0.00%
0/46
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.2%
1/46 • Number of events 1
|
10.9%
5/46 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.3%
2/46 • Number of events 2
|
10.9%
5/46 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
10.9%
5/46 • Number of events 10
|
13.0%
6/46 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
28.3%
13/46 • Number of events 22
|
67.4%
31/46 • Number of events 78
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
69.6%
32/46 • Number of events 90
|
93.5%
43/46 • Number of events 183
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/46
|
4.3%
2/46 • Number of events 3
|
|
Vascular disorders
Phlebitis
|
2.2%
1/46 • Number of events 1
|
2.2%
1/46 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
6.5%
3/46 • Number of events 3
|
13.0%
6/46 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60