Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate Cancer

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oncology Specialists, S.C.
• Treatments: Androgens; Erlotinib Hydrochloride

Criteria

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

Exclusion Criteria:

• Patients with prior exposure to Tarceva

• Patients who have received any prior systemic chemotherapy for prostate cancer. Exposure to chemotherapy for other malignancies is allowed as long as last chemotherapy was completed 3 years prior to study entry.

• Patients with prior malignancies are excluded except for those who have non-melanoma skin cancers or other cancers that are in remission with the last therapy given 3 years prior to enrollment.

• Prior exposure to any form of steroids is allowed and is not considered exclusion criteria.

• Performance status of 3 or above using ECOG scale.

• Known HIV positive status Known CNS involvement with prostate cancer