Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier:
NCT00272038
First received: January 3, 2006
Last updated: August 12, 2013
Last verified: August 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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

Primary Outcome Measures:
  • Overall Clinical Benefit of Tarceva in CRPC. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Time to Disease Progression (TTP) [ Time Frame: five years ] [ Designated as safety issue: No ]
    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 meausrable increase in a non-target lesion, or the appearance of new lesions or the appearance of two new bone lesions.

  • Overall Survival [ Time Frame: during study ] [ Designated as safety issue: No ]
    One year survival rate.

  • Toxicity [ Time Frame: during study ] [ Designated as safety issue: Yes ]

Enrollment: 29
Study Start Date: December 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tarceva
Tarceva 150 mg QD
Drug: Tarceva
150mg QD
Other Name: erlotinib

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Oncology Specialists, S.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Sigrun Hallmeyer, Sigrun Hallmeyer, MD Director of Research; Chadi Nabhan, MD Principal Investigator, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00272038     History of Changes
Obsolete Identifiers: NCT00321841
Other Study ID Numbers: OSI3652S (0513)
Study First Received: January 3, 2006
Results First Received: May 6, 2013
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Erlotinib
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014