Prostate Cancer
Conditions
Brief summary
Objectives to evaluate the activity of Erlotinib in prostate cancer patients who are hormone refractory and androgen independent and have not been exposed to chemotherapy.
Detailed description
This is a phase II open label single center study that evaluates the activity, efficacy, and toxicity of single agent Tarceva in chemotherapy-naive AIPC patients. Patients will receive single agent Tarceva at 150 mg daily without interruption until disease progression, unacceptable toxicity, or investigator's discretion. Eligible patients are those with documented prostate cancer (regardless of Gleason Score) who are considered hormone refractory as defined below. All patients must fail an anti-androgen withdrawal trial if they were already on such therapy. If patients were on LHRH analogues alone, they must fail the addition of an anti-androgen before being classified as hormone refractory. All patients must have adequate organ functions as specified below and have an ECOG performance status of 2 or less. It is hypothesized that 25 patients will be needed to adequately assess the activity of Tarceva in AIPC. The activity of Tarceva in other malignancies has been demonstrated with dosed ranging from 100 to 150 mg daily. It is acceptable not to interrupt therapy unless toxicity occurs of disease progression is documented. Starting patients at 150 mg daily seems to be the most logical step, but dose reductions will be implemented based on side effects and adverse events.
Interventions
DRUGTarceva
150mg QD
Sponsors
Oncology Specialists, S.C.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
Yes
Inclusion criteria
* Documented prostate cancer regardless of Gleason score * Patients should be considered hormone refractory and androgen independent. They must fail LHRH analogues, and anti-androgen withdrawal trial. * Failure is confirmed by an increase in PSA value of 10% or more than the value immediately before, and confirmed by another assessment 2 weeks later. * Patients have to have measurable disease either biochemically using rising PSA or/and with metastatic disease to the bone or visceral organs. * Performance status of 2 or less using ECOG scale.· Adequate liver function tests with ALT/AST being \< 3x normal, total bilirubin of 1.5 or less, and adequate renal function measured by a creatinine of 2.0 mg/dl or less. Alkaline phosphatase values are never
Exclusion criteria
if it is deemed related to bone metastases. * Patients need to have adequate bone marrow function. ANC of 1000 or above, Hgb of 9.0 g/dl or above, and platelets of 100,000 or above. If other causes are affecting plts counts such as autoimmune disorders, patients are allowed on study. * Patients with inadequate bone marrow function that is deemed related to bone marrow involvement with prostate cancer are allowed at the investigator's discretion. * Patients with other malignancies are allowed as long as there is no evidence of the other malignancy present at entry time, and it has been 3 years or more since the treatment for the other disorder was completed. * Patients with prior exposure to investigational therapies including vaccines are allowed on this study as long as their last exposure was 4 weeks prior to study entry.Patients with known bone metastases are allowed to receive intravenous bisphosphonates such as aredia or zometa. * Patients on oral bisphosphonates are also allowed. * Chemo Naive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Clinical Benefit of Tarceva in CRPC. | 5 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | during study | One year survival rate. |
| Time to Disease Progression | 25 months | 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. |
Countries
United States
Participant flow
Recruitment details
Eligible patients were those who met the criteria of Castration Resistant Prostate Cancer (CRPC)who had not yet received chemotherapy.
Pre-assignment details
Patients must have had adquate bone marrow function and, Eastern Cooperative Oncology Group (ECOG) \<3, and measurable disease.
Participants by arm
| Arm | Count |
|---|---|
| Tarceva Tarceva 150 mg QD | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | withdrew before they received 2 cycles | 7 |
Baseline characteristics
| Characteristic | Tarceva |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 27 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 29 / 29 |
| serious Total, serious adverse events | 12 / 29 |
Outcome results
Primary
Overall Clinical Benefit of Tarceva in CRPC.
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).
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tarceva | Overall Clinical Benefit of Tarceva in CRPC. | 36 percentage of pts w/clinical benefit |
Secondary
Overall Survival
One year survival rate.
Time frame: during study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tarceva | Overall Survival | 58 % of partcipants alive at one year |
Secondary
Time to Disease Progression
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.
Time frame: 25 months
Population: 29 participants enrolled. only 22 were evaluable, 4 withdrew consent, 2 had rapid PSA increase \& 1 had cord compression
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tarceva | Time to Disease Progression | 2 months |