Single Agent Erlotinib in Chemotherapy-Naive Androgen Independent Prostate Cancer - Full Text View

Sponsored by:	Oncology Specialists, S.C.
Information provided by:	Oncology Specialists, S.C.
ClinicalTrials.gov Identifier:	NCT00272038

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: Tarceva	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study Investigating the Efficacy and Activity of Single Agent Erlotinib in Chemotherapy-Naive Androgen Independent Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Oncology Specialists, S.C.:

Primary Outcome Measures:

Evaluate the overall clinical benefit of Tarcev in AIPC [ Time Frame: during study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to disease progression (TTP) [ Time Frame: During study ] [ Designated as safety issue: No ]
Time to requiring systemic chemotherapy [ Time Frame: during study ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: during study ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: during study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	December 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Tarceva 150 mg QD	Drug: Tarceva 150mg QD

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272038

Locations

United States, Illinois
Oncology Specialists, SC
Park Ridge, Illinois, United States, 60068

Sponsors and Collaborators

Oncology Specialists, S.C.

Investigators

Principal Investigator:

Chadi Nabhan, MD

Oncology Specialists, SC

More Information

No publications provided

Responsible Party:	Oncology Specialists, SC ( Chadi Nabhan, MD )
Study ID Numbers:	OSI3652S (0513)
Study First Received:	January 3, 2006
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00272038 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Erlotinib
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 01, 2009