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Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site

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ClinicalTrials.gov Identifier: NCT00360360
Recruitment Status : Completed
First Posted : August 4, 2006
Results First Posted : October 21, 2013
Last Update Posted : December 4, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasm, Unknown Primary
Interventions Drug: paclitaxel
Drug: carboplatin
Drug: bevacizumab
Drug: erlotinib
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
Hide Arm/Group Description 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
Period Title: Overall Study
Started 60
Completed 54
Not Completed 6
Arm/Group Title Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
Hide Arm/Group Description 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 Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
50
(23 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
31
  51.7%
Male
29
  48.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Hide Description [Not Specified]
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
Hide Arm/Group Description:
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 Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: months
12.6
(9.7 to 18.5)
2.Secondary Outcome
Title Progression-free Survival
Hide Description 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.
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
Hide Arm/Group Description:
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 Number of Participants Analyzed 54
Median (95% Confidence Interval)
Unit of Measure: months
8
(6.4 to 13.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
Hide Arm/Group Description 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
All-Cause Mortality
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
Affected / at Risk (%) # Events
Total   29/60 (48.33%)    
Blood and lymphatic system disorders   
Pancytopenia  1  1/60 (1.67%)  1
Cardiac disorders   
Cardiac General  1 [1]  1/60 (1.67%)  1
Hypotension  1 [2]  1/60 (1.67%)  1
Pain  1  1/60 (1.67%)  1
Pericardial tumor constriction  1  1/60 (1.67%)  1
Supraventricular and nodal arrhythmia  1 [3]  1/60 (1.67%)  1
Endocrine disorders   
Neuroendocrine: ADH secretion abnormality  1 [4]  1/60 (1.67%)  1
Gastrointestinal disorders   
Dehydration  1  7/60 (11.67%)  11
Cholecystitis  1  1/60 (1.67%)  1
Vomiting  1  1/60 (1.67%)  2
Perforation  1 [5]  1/60 (1.67%)  1
Ascites  1  2/60 (3.33%)  3
Obstruction, GI  1 [6]  1/60 (1.67%)  1
Pain  1  3/60 (5.00%)  3
Hemorrhage  1  1/60 (1.67%)  1
General disorders   
Generalized weakness  1  1/60 (1.67%)  1
Infections and infestations   
Febrile neutropenia  1  5/60 (8.33%)  5
Infection  1 [7]  1/60 (1.67%)  1
Metabolism and nutrition disorders   
Acidosis  1 [8]  1/60 (1.67%)  1
Bilirubin (hyperbilirubinemia)  1  1/60 (1.67%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue - Other  1 [9]  1/60 (1.67%)  1
Pain  1  1/60 (1.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
disease progression  1  6/60 (10.00%)  6
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/60 (1.67%)  1
Aspiration  1 [10]  1/60 (1.67%)  1
Vascular disorders   
CNS cerebrovascular ischemia  1 [11]  1/60 (1.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Cardiogenic shock
[2]
Orthostatic
[3]
Bradycardia
[4]
SIADH
[5]
Sigmoid perforation
[6]
Small bowel obstruction
[7]
Cellulitis
[8]
Diabetic ketoacidosis
[9]
Anterior chest discomfort
[10]
Pneumonia
[11]
TIA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
Affected / at Risk (%) # Events
Total   60/60 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  3/60 (5.00%)  5
Leukocytes (WBC)  1  28/60 (46.67%)  61
Neutropenia  1  3/60 (5.00%)  3
Neutrophils (ANC)  1  30/60 (50.00%)  53
Platelets  1  31/60 (51.67%)  77
Cardiac disorders   
Hypertension  1  4/60 (6.67%)  7
Hypotension  1  17/60 (28.33%)  55
Pain (chest)  1  3/60 (5.00%)  3
Gastrointestinal disorders   
Anorexia  1  31/60 (51.67%)  90
Bleeding (gums)  1  3/60 (5.00%)  3
Constipation  1  23/60 (38.33%)  45
Dehydration  1  16/60 (26.67%)  34
Diarrhea  1  40/60 (66.67%)  139
Dyspepsia  1  3/60 (5.00%)  8
Dysphagia  1  4/60 (6.67%)  7
Indigestion  1  3/60 (5.00%)  15
Mouth (sore)  1  3/60 (5.00%)  3
Mucositis  1  8/60 (13.33%)  17
Nausea  1  40/60 (66.67%)  125
Pain (abdominal)  1  10/60 (16.67%)  15
Taste alteration  1  6/60 (10.00%)  14
General disorders   
Fatigue  1  45/60 (75.00%)  237
Fever  1  8/60 (13.33%)  8
Insomnia  1  9/60 (15.00%)  24
Night Sweats  1  3/60 (5.00%)  3
Pain (NOS)  1  3/60 (5.00%)  5
Weight Loss  1  9/60 (15.00%)  35
Immune system disorders   
Allergic Reaction/Hypersensitivity Grade  1  6/60 (10.00%)  8
Infections and infestations   
Neutropenic fever  1  3/60 (5.00%)  3
Metabolism and nutrition disorders   
Hemoglobin  1  34/60 (56.67%)  124
Hyperglycemia  1  8/60 (13.33%)  16
Hyperkalemia  1  6/60 (10.00%)  12
Hypoglycemia  1  3/60 (5.00%)  3
Hypokalemia  1  3/60 (5.00%)  3
Hyponatremia  1  5/60 (8.33%)  5
Proteinuria  1  12/60 (20.00%)  20
Musculoskeletal and connective tissue disorders   
Myalgia  1  13/60 (21.67%)  34
Pain (back)  1  5/60 (8.33%)  20
Pain (bone)  1  6/60 (10.00%)  8
Pain (legs)  1  3/60 (5.00%)  4
Weakness  1  3/60 (5.00%)  3
Nervous system disorders   
Dizziness/Lightheadedness  1  5/60 (8.33%)  10
Headache  1  12/60 (20.00%)  31
Neuropathy-sensory  1  19/60 (31.67%)  101
Psychiatric disorders   
Depression  1  4/60 (6.67%)  6
Mood alteration (anxiety)  1  7/60 (11.67%)  15
Mood alteration (confusion)  1  3/60 (5.00%)  4
Mood alteration (depression)  1  5/60 (8.33%)  6
Respiratory, thoracic and mediastinal disorders   
Cough  1  13/60 (21.67%)  20
Dyspnea  1  15/60 (25.00%)  42
Epistaxis  1  15/60 (25.00%)  28
Hoarseness  1  4/60 (6.67%)  11
Sinus congestion  1  5/60 (8.33%)  7
Sinus drainage  1  3/60 (5.00%)  6
Throat (sore)  1  4/60 (6.67%)  6
Skin and subcutaneous tissue disorders   
Rash (acneiform)  1  5/60 (8.33%)  7
Alopecia  1  27/60 (45.00%)  94
Pruritis  1  16/60 (26.67%)  27
Rash (facial)  1  3/60 (5.00%)  5
Rash/Desquamation  1  45/60 (75.00%)  218
Skin (dry)  1  7/60 (11.67%)  20
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-MY-1-SCRI
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00360360     History of Changes
Other Study ID Numbers: SCRI UNKPRI 19
First Submitted: August 2, 2006
First Posted: August 4, 2006
Results First Submitted: August 15, 2013
Results First Posted: October 21, 2013
Last Update Posted: December 4, 2013