Trial Outcomes & Findings for Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site (NCT NCT00360360)
NCT ID: NCT00360360
Last Updated: 2013-12-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
18 months
Results posted on
2013-12-04
Participant Flow
Participant milestones
| Measure |
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site
Baseline characteristics by cohort
| Measure |
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
n=60 Participants
Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
|
|---|---|
|
Age Continuous
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsOutcome measures
| Measure |
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
n=54 Participants
Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
|
|---|---|
|
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
|
12.6 months
Interval 9.7 to 18.5
|
SECONDARY outcome
Timeframe: 18 monthsProgression 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 |
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
n=54 Participants
Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
|
|---|---|
|
Progression-free Survival
|
8 months
Interval 6.4 to 13.8
|
Adverse Events
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
Serious events: 29 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
n=60 participants at risk
Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
|
|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
11.7%
7/60 • Number of events 11
|
|
Infections and infestations
Febrile neutropenia
|
8.3%
5/60 • Number of events 5
|
|
Gastrointestinal disorders
Cholecystitis
|
1.7%
1/60 • Number of events 1
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Number of events 2
|
|
Endocrine disorders
Neuroendocrine: ADH secretion abnormality
|
1.7%
1/60 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
1.7%
1/60 • Number of events 1
|
|
Cardiac disorders
Cardiac General
|
1.7%
1/60 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain
|
1.7%
1/60 • Number of events 1
|
|
Infections and infestations
Infection
|
1.7%
1/60 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/60 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Perforation
|
1.7%
1/60 • Number of events 1
|
|
Cardiac disorders
Pain
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
3.3%
2/60 • Number of events 3
|
|
Gastrointestinal disorders
Obstruction, GI
|
1.7%
1/60 • Number of events 1
|
|
Cardiac disorders
Pericardial tumor constriction
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Pain
|
5.0%
3/60 • Number of events 3
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.7%
1/60 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.7%
1/60 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage
|
1.7%
1/60 • Number of events 1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
1.7%
1/60 • Number of events 1
|
|
Vascular disorders
CNS cerebrovascular ischemia
|
1.7%
1/60 • Number of events 1
|
|
General disorders
Generalized weakness
|
1.7%
1/60 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
disease progression
|
10.0%
6/60 • Number of events 6
|
Other adverse events
| Measure |
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
n=60 participants at risk
Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash (acneiform)
|
8.3%
5/60 • Number of events 7
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity Grade
|
10.0%
6/60 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
45.0%
27/60 • Number of events 94
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
3/60 • Number of events 5
|
|
Gastrointestinal disorders
Anorexia
|
51.7%
31/60 • Number of events 90
|
|
Gastrointestinal disorders
Bleeding (gums)
|
5.0%
3/60 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
38.3%
23/60 • Number of events 45
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.7%
13/60 • Number of events 20
|
|
Gastrointestinal disorders
Dehydration
|
26.7%
16/60 • Number of events 34
|
|
Psychiatric disorders
Depression
|
6.7%
4/60 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
40/60 • Number of events 139
|
|
Nervous system disorders
Dizziness/Lightheadedness
|
8.3%
5/60 • Number of events 10
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
3/60 • Number of events 8
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
4/60 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
15/60 • Number of events 42
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
15/60 • Number of events 28
|
|
General disorders
Fatigue
|
75.0%
45/60 • Number of events 237
|
|
General disorders
Fever
|
13.3%
8/60 • Number of events 8
|
|
Nervous system disorders
Headache
|
20.0%
12/60 • Number of events 31
|
|
Metabolism and nutrition disorders
Hemoglobin
|
56.7%
34/60 • Number of events 124
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.7%
4/60 • Number of events 11
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
8/60 • Number of events 16
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
6/60 • Number of events 12
|
|
Cardiac disorders
Hypertension
|
6.7%
4/60 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
3/60 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.0%
3/60 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.3%
5/60 • Number of events 5
|
|
Cardiac disorders
Hypotension
|
28.3%
17/60 • Number of events 55
|
|
Gastrointestinal disorders
Indigestion
|
5.0%
3/60 • Number of events 15
|
|
General disorders
Insomnia
|
15.0%
9/60 • Number of events 24
|
|
Blood and lymphatic system disorders
Leukocytes (WBC)
|
46.7%
28/60 • Number of events 61
|
|
Psychiatric disorders
Mood alteration (anxiety)
|
11.7%
7/60 • Number of events 15
|
|
Psychiatric disorders
Mood alteration (confusion)
|
5.0%
3/60 • Number of events 4
|
|
Psychiatric disorders
Mood alteration (depression)
|
8.3%
5/60 • Number of events 6
|
|
Gastrointestinal disorders
Mouth (sore)
|
5.0%
3/60 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis
|
13.3%
8/60 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.7%
13/60 • Number of events 34
|
|
Gastrointestinal disorders
Nausea
|
66.7%
40/60 • Number of events 125
|
|
Nervous system disorders
Neuropathy-sensory
|
31.7%
19/60 • Number of events 101
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
3/60 • Number of events 3
|
|
Infections and infestations
Neutropenic fever
|
5.0%
3/60 • Number of events 3
|
|
Blood and lymphatic system disorders
Neutrophils (ANC)
|
50.0%
30/60 • Number of events 53
|
|
General disorders
Night Sweats
|
5.0%
3/60 • Number of events 3
|
|
General disorders
Pain (NOS)
|
5.0%
3/60 • Number of events 5
|
|
Gastrointestinal disorders
Pain (abdominal)
|
16.7%
10/60 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
Pain (back)
|
8.3%
5/60 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Pain (bone)
|
10.0%
6/60 • Number of events 8
|
|
Cardiac disorders
Pain (chest)
|
5.0%
3/60 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain (legs)
|
5.0%
3/60 • Number of events 4
|
|
Blood and lymphatic system disorders
Platelets
|
51.7%
31/60 • Number of events 77
|
|
Metabolism and nutrition disorders
Proteinuria
|
20.0%
12/60 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
26.7%
16/60 • Number of events 27
|
|
Skin and subcutaneous tissue disorders
Rash (facial)
|
5.0%
3/60 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
75.0%
45/60 • Number of events 218
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.3%
5/60 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Sinus drainage
|
5.0%
3/60 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Skin (dry)
|
11.7%
7/60 • Number of events 20
|
|
Gastrointestinal disorders
Taste alteration
|
10.0%
6/60 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Throat (sore)
|
6.7%
4/60 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
5.0%
3/60 • Number of events 3
|
|
General disorders
Weight Loss
|
15.0%
9/60 • Number of events 35
|
Additional Information
John D. Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-MY-1-SCRI
Email: [email protected]
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