Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate Cancer

NCT00272038 | Completed Phase 2 Results

• 1 other identifier: OSI3652S (0513)
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  5 years

Secondary Outcomes (2)

• Overall Survival

  during study

• Time to Disease Progression

  25 months

Study Arms (1)

Tarceva

EXPERIMENTAL

Tarceva 150 mg QD

Drug: Tarceva

Interventions

Tarceva DRUG

150mg QD

Also known as: erlotinib

Tarceva

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Performance status of 3 or above using ECOG scale.
• Known HIV positive status Known CNS involvement with prostate cancer

Sponsors & Collaborators

• Oncology Specialists, S.C.: lead

Study Sites (1)

Oncology Specialists, SC

Park Ridge, Illinois, 60068, United States

Location

Related Publications (1)

• Nabhan C, Lestingi TM, Galvez A, Tolzien K, Kelby SK, Tsarwhas D, Newman S, Bitran JD. Erlotinib has moderate single-agent activity in chemotherapy-naive castration-resistant prostate cancer: final results of a phase II trial. Urology. 2009 Sep;74(3):665-71. doi: 10.1016/j.urology.2009.05.016. Epub 2009 Jul 17.

  PMID: 19616281 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Sigrun Hallmeyer, MD (Director of Research); Chadi Nabhan, MD, FACP (PI)
• Organization: Oncology Specialists, S.C.

shallmeyer@oncmed.net

847-268-8200

Study Officials

• Chadi Nabhan, MD

  Oncology Specialists, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sigrun Hallmeyer, MD Director of Research; Chadi Nabhan, MD Principal Investigator

Study Record Dates

• First Submitted: January 3, 2006
• First Posted: January 4, 2006
• Study Start: December 1, 2005
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 27, 2018
• Results First Posted: October 17, 2013

Record last verified: 2018-05

Locations

US (1)