Trial Outcomes & Findings for Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate Cancer (NCT NCT00272038)
NCT ID: NCT00272038
Last Updated: 2018-06-27
Results Overview
Overall Clinical Benefit = percentage of partial responders (PR)+ the percentage of patients with stable disease (SD). Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease (SD)is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0).
COMPLETED
PHASE2
29 participants
5 years
2018-06-27
Participant Flow
Eligible patients were those who met the criteria of Castration Resistant Prostate Cancer (CRPC)who had not yet received chemotherapy.
Patients must have had adquate bone marrow function and, Eastern Cooperative Oncology Group (ECOG) \<3, and measurable disease.
Participant milestones
| Measure |
Tarceva
Tarceva 150 mg orally every day
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Tarceva
Tarceva 150 mg orally every day
|
|---|---|
|
Overall Study
withdrew before they received 2 cycles
|
7
|
Baseline Characteristics
Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate Cancer
Baseline characteristics by cohort
| Measure |
Tarceva
n=29 Participants
Tarceva 150 mg QD
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 5 yearsOverall Clinical Benefit = percentage of partial responders (PR)+ the percentage of patients with stable disease (SD). Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease (SD)is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0).
Outcome measures
| Measure |
Tarceva
n=22 Participants
Tarceva 150 mg QD
|
|---|---|
|
Overall Clinical Benefit of Tarceva in CRPC.
|
36 percentage of pts w/clinical benefit
|
SECONDARY outcome
Timeframe: during studyOne year survival rate.
Outcome measures
| Measure |
Tarceva
n=22 Participants
Tarceva 150 mg QD
|
|---|---|
|
Overall Survival
|
58 % of partcipants alive at one year
|
SECONDARY outcome
Timeframe: 25 monthsPopulation: 29 participants enrolled. only 22 were evaluable, 4 withdrew consent, 2 had rapid PSA increase \& 1 had cord compression
Patients were evaluated for response biochemically and radiographically at each response assessment. RECIST 1.0 criteria were used for radiographic response. PSA measurement at a central laboratory was used to assess biochemical response. Patients must have had a baseline PSA of 5 ng/ml to be evaluated for PSA response. PSA was measured every 8 weeks. For patients with measurable disease radiographically, PSA progression was not considered as having progressive disease. Refer to study publication for details.
Outcome measures
| Measure |
Tarceva
n=22 Participants
Tarceva 150 mg QD
|
|---|---|
|
Time to Disease Progression
|
2 months
Interval 1.0 to
Not all participants experienced progression
|
Adverse Events
Tarceva
Serious adverse events
| Measure |
Tarceva
n=29 participants at risk
Tarceva 150 mg QD
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Chest Pain
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29
|
|
Renal and urinary disorders
Hematuria
|
17.2%
5/29
|
|
Gastrointestinal disorders
Gastro Intestinal Bleed
|
3.4%
1/29
|
|
Renal and urinary disorders
Renal Failure
|
3.4%
1/29
|
|
Cardiac disorders
Congestive Heart Failure
|
3.4%
1/29
|
|
General disorders
Weakness
|
6.9%
2/29
|
|
Musculoskeletal and connective tissue disorders
Involuntary Movement of Hands and Arms
|
3.4%
1/29
|
|
General disorders
Dehydration
|
6.9%
2/29
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Emboli
|
3.4%
1/29
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29
|
|
Gastrointestinal disorders
Bowel Obstruction
|
3.4%
1/29
|
|
General disorders
Decompensation
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Spinal Cord Compression
|
3.4%
1/29
|
|
Infections and infestations
Cellulitis
|
3.4%
1/29
|
Other adverse events
| Measure |
Tarceva
n=29 participants at risk
Tarceva 150 mg QD
|
|---|---|
|
Renal and urinary disorders
Low Creatinine Grade 3 & 4
|
6.9%
2/29
|
|
Blood and lymphatic system disorders
Alkaline Phosphatase High Grade 3 & 4
|
6.9%
2/29
|
|
General disorders
Fatigue Grade 3 & 4
|
6.9%
2/29
|
|
Infections and infestations
Pneumonia Grade 3 & 4
|
6.9%
2/29
|
|
General disorders
Rash Grade 3 & 4
|
6.9%
2/29
|
|
Gastrointestinal disorders
Diarrhea Grade 3 & 4
|
10.3%
3/29
|
|
Blood and lymphatic system disorders
Aspartate Aminotransferase Elevated Grade 1 - 4
|
6.9%
2/29
|
|
Blood and lymphatic system disorders
Anemia Grade 1 & 2
|
41.4%
12/29
|
|
Nervous system disorders
Arthralgia Grade 1 & 2
|
31.0%
9/29
|
|
Gastrointestinal disorders
Appetite decreased Grade 1 & 2
|
51.7%
15/29
|
|
Renal and urinary disorders
Anxiety Grade 1 & 2
|
31.0%
9/29
|
|
Renal and urinary disorders
Alkaline Phosphatase Increased Grade 1 & 2
|
10.3%
3/29
|
|
Vascular disorders
Bruises easily
|
17.2%
5/29
|
|
Gastrointestinal disorders
Calcium Low Grade 1 & 2
|
20.7%
6/29
|
|
Gastrointestinal disorders
Constipation Grade 1 & 2
|
17.2%
5/29
|
|
General disorders
Chest Pain Grade 1 & 2
|
13.8%
4/29
|
|
General disorders
Chills Grade 1 & 2
|
17.2%
5/29
|
|
Respiratory, thoracic and mediastinal disorders
Cough Grade 1 & 2
|
17.2%
5/29
|
|
Respiratory, thoracic and mediastinal disorders
Dsynea on Exertion Grade 1 & 2
|
10.3%
3/29
|
|
Psychiatric disorders
Depression Grade 1 & 2
|
34.5%
10/29
|
|
Gastrointestinal disorders
Dehydration Grade 1 - 4
|
17.2%
5/29
|
|
Gastrointestinal disorders
Diarrhea Grade 1 & 2
|
75.9%
22/29
|
|
General disorders
Edema Grade 1 & 2
|
13.8%
4/29
|
|
General disorders
Fatigue Grade 1 - 4
|
48.3%
14/29
|
|
Infections and infestations
Fever Grade 1 & 2
|
13.8%
4/29
|
|
Infections and infestations
Fungal Infection Grade 1 & 2
|
10.3%
3/29
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease Grade 1 & 2
|
13.8%
4/29
|
|
Skin and subcutaneous tissue disorders
Hand Foot Syndrome Grade 1 - 4
|
10.3%
3/29
|
|
General disorders
Hematuria Grade 1 & 2
|
17.2%
5/29
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptesis Grade 1 & 2
|
10.3%
3/29
|
|
Nervous system disorders
Headache Grade 1 & 2
|
20.7%
6/29
|
|
General disorders
Hot Flashes Grade 1 & 2
|
17.2%
5/29
|
|
Skin and subcutaneous tissue disorders
Hives Grade 1 & 2
|
17.2%
5/29
|
|
Gastrointestinal disorders
Hyperglycemia Grade 1 - 4
|
20.7%
6/29
|
|
Infections and infestations
Infection Grade 1 & 2
|
24.1%
7/29
|
|
Psychiatric disorders
Insomnia Grade 1 & 2
|
17.2%
5/29
|
|
Skin and subcutaneous tissue disorders
Itching Grade 1 & 2
|
24.1%
7/29
|
|
Blood and lymphatic system disorders
Lymphopenia Grade 1 - 4
|
20.7%
6/29
|
|
Nervous system disorders
Lightheadedness Grade 1 & 2
|
27.6%
8/29
|
|
General disorders
Libido decreased Grade 1 & 2
|
13.8%
4/29
|
|
Gastrointestinal disorders
Mouth Sores Grade 1 & 2
|
24.1%
7/29
|
|
Gastrointestinal disorders
Mouth Dry Grade 1 & 2
|
37.9%
11/29
|
|
Skin and subcutaneous tissue disorders
Nail changes Grade 1 & 2
|
6.9%
2/29
|
|
Blood and lymphatic system disorders
Potassium Decreased Grade 1 & 2
|
6.9%
2/29
|
|
Blood and lymphatic system disorders
Potassium Increased Grade 1 & 2
|
6.9%
2/29
|
|
Gastrointestinal disorders
Protein Decreased Grade 1 & 2
|
6.9%
2/29
|
|
Renal and urinary disorders
Renal Insufficiency Grade 1 - 4
|
10.3%
3/29
|
|
Gastrointestinal disorders
Swallowing Difficulty Grade 1 & 2
|
6.9%
2/29
|
|
Gastrointestinal disorders
Sodium Decreased Grade 1 & 2
|
6.9%
2/29
|
|
Gastrointestinal disorders
Taste Change Grade 1 & 2
|
6.9%
2/29
|
|
Infections and infestations
Urinary Tract Infection Grade 1 & 2
|
6.9%
2/29
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing Grade 1 & 2
|
6.9%
2/29
|
|
Renal and urinary disorders
Blood Urea Nitrogen increased Grade 1 & 2
|
6.9%
2/29
|
|
Renal and urinary disorders
Creatinine Increased Grade 1 & 2
|
6.9%
2/29
|
|
General disorders
Eyes dry Grade 1 & 2
|
6.9%
2/29
|
|
General disorders
Eyes Watery Grade 1 & 2
|
6.9%
2/29
|
|
General disorders
Memory Loss Grade 1 & 2
|
6.9%
2/29
|
Additional Information
Sigrun Hallmeyer, MD (Director of Research); Chadi Nabhan, MD, FACP (PI)
Oncology Specialists, S.C.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place