Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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Antineoplastic Agents

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Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Oral Single agent Sorafenib 400mg twice daily

Chadi Nabhan, MD

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

Patients who have AIPC and are progressing despite systemic chemotherapy will be offered participation in this study. Patients who relapse or progress shortly (within 12 weeks) after discontinuation of chemotherapy with either docetaxel/prednisone or mitoxantrone/prednisone will also be offered participation in this trial. Enrolled patients will receive sorafenib as per protocol define dose. Sorafenib will be administered in combination with the last chemotherapy utilized. If there is no disease progression after 6 cycles, chemotherapy will be stopped and Sorafenib may continue until disease progression.

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

Phase I/II Study to Evaluate the Ability of Sorafenib in Overcoming Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer (AIPC)

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

Assessment of response was done per Response Evaluation Criteria in Solid Tumors (RECIST) criteria as outlined in the protocol. Complete Response (CR) defined as disappearance of all measurable lesions. Partial Response (PR) more than 30% decrease in the sum of longest diameter of measurable lesions compared to baseline. Stable Disease (SD) lesions should have no sufficient decrease for PR any sufficient increase to meet criteria for PD. Progressive Disease (PD) more than 20% increase in the sum of longest diameter of measurable lesions compared to baseline, and/or evidence of new lesions on imaging studies or the appearance of 2 or more new bony lesions. For patient with measurable disease,prostate-specific antigen (PSA), progression in the absence of measurable disease progression will not be considered progressive disease. Overall Clinical Benefit (OCB) (CR + PR+ SD)/#participants.

PSA Biochemical Response = PSA complete response + PSA partial response. A PSA complete response is defined as a non-detectable PSA (\<4 ng/dl). A PSA partial response is defined as a PSA that decreases by greater than or equal to 50%.

Oncology Specialists, S.C.

Director of Research

Single Agent Sorafenib

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Recruitment was from our clinic population. Eligible patients were those who progressed while receiving chemotherapy (docetaxel or mitoxantrone)or within 12 weeks of stopping chemo

Sigrun Hallmeyer, MD (Director of Research); Chadi Nabhan, MD (PI)

Percentage of Patients Needing a Dose Reduction.

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

Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (Docetaxel or Mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m2 and Mitoxantrone was given at 12 mg/m2, both once every 21 days and both combined with Prednisone at 5mg twice daily. A maximum of 6 cycles of Sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive Sorafenib monotherapy until disease progression.

PSA -Biochemical Response

Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (docetaxel or mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m\^2 and mitoxantrone was given at 12 mg/m\^2, both once every 21 days and both combined with prednisone at 5mg twice daily. A maximum of 6 cycles of sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive sorafenib monotherapy until disease progression.

Spots Global Cancer Trial Database for Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer

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