Trial Outcomes & Findings for Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site (NCT NCT00193596)
NCT ID: NCT00193596
Last Updated: 2013-05-03
Results Overview
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
198 participants
Primary outcome timeframe
24 months
Results posted on
2013-05-03
Participant Flow
Participant milestones
| Measure |
Paclitaxel/Carboplatin/Etoposide/Gefitinib
Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval
|
Irinotecan/Gemcitabine/Gefitinib
Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
105
|
|
Overall Study
COMPLETED
|
37
|
39
|
|
Overall Study
NOT COMPLETED
|
56
|
66
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
Baseline characteristics by cohort
| Measure |
Paclitaxel/Carboplatin/Etoposide/Gefitinib
n=93 Participants
Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval
|
Irinotecan/Gemcitabine/Gefitinib
n=105 Participants
Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
61 years
n=5 Participants
|
59 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
105 participants
n=7 Participants
|
198 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsLength of time, in months, that patients were alive from their first date of protocol treatment until death.
Outcome measures
| Measure |
Paclitaxel/Carboplatin/Etoposide/Gefitinib
n=93 Participants
Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval
|
Irinotecan/Gemcitabine/Gefitinib
n=105 Participants
Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval
|
|---|---|---|
|
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
|
7.4 months
Interval 4.67 to 10.28
|
8.5 months
Interval 6.64 to 10.58
|
SECONDARY outcome
Timeframe: 12 monthsLength of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Outcome measures
| Measure |
Paclitaxel/Carboplatin/Etoposide/Gefitinib
n=93 Participants
Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval
|
Irinotecan/Gemcitabine/Gefitinib
n=105 Participants
Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval
|
|---|---|---|
|
Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
|
3.3 months
Interval 2.2 to 4.86
|
5.3 months
Interval 3.88 to 6.21
|
Adverse Events
Paclitaxel/Carboplatin/Etoposide/Gefitinib
Serious events: 56 serious events
Other events: 93 other events
Deaths: 0 deaths
Irinotecan/Gemcitabine/Gefitinib
Serious events: 57 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel/Carboplatin/Etoposide/Gefitinib
n=93 participants at risk
Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval
|
Irinotecan/Gemcitabine/Gefitinib
n=105 participants at risk
Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval
|
|---|---|---|
|
Eye disorders
Ocular - Other
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Infections and infestations
Febrile Neutropenia
|
17.2%
16/93 • Number of events 16
|
4.8%
5/105 • Number of events 5
|
|
General disorders
Death
|
9.7%
9/93 • Number of events 9
|
7.6%
8/105 • Number of events 8
|
|
Infections and infestations
Infection - Skin
|
1.1%
1/93 • Number of events 1
|
1.9%
2/105 • Number of events 2
|
|
Infections and infestations
Infection - Pneumonia
|
4.3%
4/93 • Number of events 4
|
0.95%
1/105 • Number of events 1
|
|
Cardiac disorders
Superventricular Arrhythmia - Supraventricular tachycardia
|
1.1%
1/93 • Number of events 1
|
2.9%
3/105 • Number of events 3
|
|
General disorders
Pain - Abdomen
|
1.1%
1/93 • Number of events 1
|
2.9%
3/105 • Number of events 3
|
|
Gastrointestinal disorders
Dehydration
|
7.5%
7/93 • Number of events 8
|
4.8%
5/105 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/93
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Infection with Unknown ANC
|
0.00%
0/93
|
0.95%
1/105 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils
|
3.2%
3/93 • Number of events 3
|
2.9%
3/105 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
5/93 • Number of events 5
|
3.8%
4/105 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/93
|
1.9%
2/105 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
6/93 • Number of events 7
|
0.00%
0/105
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
2.2%
2/93 • Number of events 2
|
4.8%
5/105 • Number of events 5
|
|
Infections and infestations
Infection - GI
|
0.00%
0/93
|
0.95%
1/105 • Number of events 1
|
|
Cardiac disorders
Cardiopulmonary Arrest
|
2.2%
2/93 • Number of events 2
|
2.9%
3/105 • Number of events 3
|
|
Hepatobiliary disorders
Pancreatitis
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Nervous system disorders
Neurology - Other
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - COPD Exacerbation
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
2.2%
2/93 • Number of events 2
|
0.95%
1/105 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/93
|
3.8%
4/105 • Number of events 5
|
|
Nervous system disorders
Spinal Cord Compression
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Nervous system disorders
Syncope
|
1.1%
1/93 • Number of events 1
|
1.9%
2/105 • Number of events 2
|
|
Nervous system disorders
Seizure
|
0.00%
0/93
|
0.95%
1/105 • Number of events 1
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.2%
2/93 • Number of events 2
|
1.9%
2/105 • Number of events 2
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/93
|
2.9%
3/105 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.2%
2/93 • Number of events 2
|
2.9%
3/105 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
2/93 • Number of events 2
|
1.9%
2/105 • Number of events 2
|
|
Nervous system disorders
Confusion
|
2.2%
2/93 • Number of events 3
|
1.9%
2/105 • Number of events 2
|
|
Immune system disorders
Allergic Reaction
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.2%
2/93 • Number of events 3
|
0.00%
0/105
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/93
|
1.9%
2/105 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Bronchitis
|
0.00%
0/93
|
0.95%
1/105 • Number of events 1
|
|
Hepatobiliary disorders
Obstruction - Bile Duct
|
2.2%
2/93 • Number of events 2
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratary - Other
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Gastrointestinal disorders
Ulcer, GI
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/93
|
0.95%
1/105 • Number of events 1
|
|
Infections and infestations
Infection - Renal/Genitourinary
|
0.00%
0/93
|
0.95%
1/105 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.1%
1/93 • Number of events 1
|
0.95%
1/105 • Number of events 1
|
|
General disorders
Fever
|
1.1%
1/93 • Number of events 1
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
Obstruction - GI
|
0.00%
0/93
|
1.9%
2/105 • Number of events 2
|
|
Infections and infestations
Infection - Sepsis
|
4.3%
4/93 • Number of events 4
|
0.95%
1/105 • Number of events 1
|
|
Nervous system disorders
Neuropathy
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/93
|
0.95%
1/105 • Number of events 1
|
|
Gastrointestinal disorders
GI - Other
|
0.00%
0/93
|
0.95%
1/105 • Number of events 1
|
|
Blood and lymphatic system disorders
Edema: Head and Neck
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Gastrointestinal disorders
Reflux
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Vascular disorders
Phlebitis
|
0.00%
0/93
|
0.95%
1/105 • Number of events 2
|
|
Cardiac disorders
Valvular Heart Disease
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.00%
0/93
|
1.9%
2/105 • Number of events 2
|
|
Vascular disorders
Peripheal Arterial Ischemia
|
0.00%
0/93
|
0.95%
1/105 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Blood and lymphatic system disorders
Anemia
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Cardiac disorders
Vasovagal Episode
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
1/93 • Number of events 1
|
0.00%
0/105
|
|
Hepatobiliary disorders
Liver Dysfunction
|
1.1%
1/93 • Number of events 1
|
0.95%
1/105 • Number of events 1
|
Other adverse events
| Measure |
Paclitaxel/Carboplatin/Etoposide/Gefitinib
n=93 participants at risk
Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1
Carboplatin area under the curve (AUC) 6.0 IV, day 1
Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10
Regimen A was repeated at a 21-day interval
|
Irinotecan/Gemcitabine/Gefitinib
n=105 participants at risk
Irinotecan 100 mg/m2 IV, days 1 and 8
Gemcitabine 1000 mg/m2 IV, days 1 and 8
Regimen B was repeated at a 21-day interval
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
75.3%
70/93 • Number of events 243
|
42.9%
45/105 • Number of events 130
|
|
Gastrointestinal disorders
Anorexia
|
62.4%
58/93 • Number of events 108
|
62.9%
66/105 • Number of events 141
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
41.9%
39/93 • Number of events 80
|
0.00%
0/105
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/93
|
34.3%
36/105 • Number of events 65
|
|
Gastrointestinal disorders
Diarrhea
|
45.2%
42/93 • Number of events 67
|
58.1%
61/105 • Number of events 115
|
|
Blood and lymphatic system disorders
Edema - NOS
|
26.9%
25/93 • Number of events 44
|
32.4%
34/105 • Number of events 74
|
|
General disorders
Fatigue
|
100.0%
93/93 • Number of events 300
|
100.0%
105/105 • Number of events 363
|
|
Infections and infestations
Febrile Neutropenia
|
32.3%
30/93 • Number of events 32
|
0.00%
0/105
|
|
Blood and lymphatic system disorders
Hemoglobin
|
62.4%
58/93 • Number of events 138
|
57.1%
60/105 • Number of events 137
|
|
Infections and infestations
Infection - NOS
|
31.2%
29/93 • Number of events 38
|
0.00%
0/105
|
|
Blood and lymphatic system disorders
Leukocytes
|
59.1%
55/93 • Number of events 160
|
48.6%
51/105 • Number of events 143
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
26.9%
25/93 • Number of events 39
|
0.00%
0/105
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
29.0%
27/93 • Number of events 46
|
0.00%
0/105
|
|
Gastrointestinal disorders
Nausea
|
88.2%
82/93 • Number of events 164
|
81.0%
85/105 • Number of events 196
|
|
Nervous system disorders
Neuropathy
|
53.8%
50/93 • Number of events 143
|
0.00%
0/105
|
|
Blood and lymphatic system disorders
Neutrophils
|
55.9%
52/93 • Number of events 115
|
30.5%
32/105 • Number of events 84
|
|
General disorders
Pain
|
76.3%
71/93 • Number of events 164
|
76.2%
80/105 • Number of events 163
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - NOS
|
41.9%
39/93 • Number of events 67
|
38.1%
40/105 • Number of events 82
|
|
Gastrointestinal disorders
Vomiting
|
51.6%
48/93 • Number of events 70
|
45.7%
48/105 • Number of events 79
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER