Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer

NCT00414388 | Completed Phase 1 Results

• 1 other identifier: 0603
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.

Conditions

Prostate Cancer

Keywords

AIPC

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Needing a Dose Reduction.

  The actual percentage was determined by taking the number of patients requiring a dose reduction divided by the total number of patients multiplied by100%

  participants were followed for an average of 25 months

Secondary Outcomes (2)

• Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).

  3-10 months

• PSA -Biochemical Response

  1-10 months

Study Arms (1)

Single agent Sorafenib

EXPERIMENTAL

Oral Single agent Sorafenib 400mg twice daily

Drug: Sorafenib

Interventions

Sorafenib DRUG

400mg twice daily

Also known as: Nexavar

Single agent Sorafenib

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2.
• Patients with a known diagnosis of prostate cancer regardless of their Gleason grade.
• Patients have AIPC.
• Adequate bone marrow, liver and renal function as assessed by:
• Hemoglobin \> 9.0 g/dl
• absolute neutrophil count (ANC) \> 1,000/mm3
• Platelet count \> 75,000/mm3
• Total bilirubin \< 1.5 x upper limit of normal (ULN)
• Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< 2.5 x the ULN (\< 5 x ULN for patients with liver involvement). international normalized ratio (INR) \< 1.5 or a Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate.
• Creatinine \< 1.5 x ULN
• Transfusions and the use of growth factors (for red and white cells) are allowed
• Patients must have received either docetaxel or mitoxantrone as the chemotherapy regimen
• Ability to understand and willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
• Patients must have progressed while receiving systemic chemotherapy for AIPC. Patients could have progressed within 12 weeks of their last systemic chemotherapy administration. The definition of progression is defined as follows:

You may not qualify if:

• Cardiac disease: Congestive heart failure \> class II New York Heart Association 9NYHA). Patients must not have unstable angina or new onset angina or myocardial infarction within the past 6 months.
• Known brain metastasis. Patients with neurological symptoms must undergo a CT scan or MRI of brain to exclude brain metastasis.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Patients with history of chronic and well controlled atrial fibrillation are allowed. Beta-blockers, calcium channel blockers, or digoxin are not considered anti-arrhythmics.
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
• Active clinically serious infection \> Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2.
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug.
• Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug.
• Serious non-healing wound, ulcer, or bone fracture.
• Evidence or history of bleeding diathesis or uncontrolled coagulopathy.
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• Use of St. John's Wort or rifampin (rifampicin).
• Known or suspected allergy to sorafenib or any agent given in the course of this trial.

Sponsors & Collaborators

• Oncology Specialists, S.C.: lead

Study Sites (2)

Onocology Specialists, S.C

Niles, Illinois, 60714, United States

Location

Oncology Specialists, S.C

Park Ridge, Illinois, 60068, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sorafenib

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)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Sigrun Hallmeyer, MD (Director of Research); Chadi Nabhan, MD (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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Study Start: December 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 7, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-02

Locations

US (2)