Sorafenib and Docetaxel in Patients With Prostate Cancer That Did Not Respond to Previous Hormone Therapy

NCT00589420 | Completed Phase 2 Results

• 3 other identifiers: UPCC 03806805372CDR0000581020
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel may kill more tumor cells. PURPOSE: This phase II trial is studying giving sorafenib together with docetaxel to see how well it works in treating patients with metastatic androgen-independent prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Prostate Specific Antigen (PSA) Response Rate

  PSA Response: ≥50% decline from baseline PSA measurement confirmed by a second PSA measurement 3 weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression. PSA progression (PSA-P): Two measurements of rising serum PSA measured at least 2 weeks apart where the second is greater than the first.

  From start of treatment until withdrawal from the study, approximately 12 months

Secondary Outcomes (2)

• 6-month Progression-free Survival (PFS)

  6 months from end of treatment

• Objective Response Rate (ORR)

  6 months from end of treatment

Study Arms (1)

Phase II

EXPERIMENTAL

All patients received sorafenib 200 mg bid daily and docetaxel 75 mg/m2 every 3 weeks

Drug: docetaxel; Drug: sorafenib tosylate

Interventions

docetaxel DRUG

Also known as: Taxotere

Phase II

sorafenib tosylate DRUG

Also known as: Nexavar

Phase II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiological evidence of metastatic disease.
• Serum PSA \>5 ng/mL.
• Patients must have discontinued flutamide or nilutamide for at least 4 weeks and bicalutamide for at least 6 weeks
• Disease progression during hormonal therapy defined as at least one of the following:
• increasing serum PSA levels on at least two measurements at least two weeks apart.
• Progressive measurable disease (by RECIST criteria) independent of PSA
• Bone scan progression with at least one new lesion.
• Serum testosterone ≤ 50 ng/dL. Patients must be receiving primary androgen ablation therapy with a GnRH agonist as maintenance therapy unless surgically castrated.
• Age \> 18 years.
• ECOG performance status of ≤ 1.
• Baseline laboratory values (evaluated within 14 days of randomization):
• White Blood Count \> 3,000/mm3 Absolute Granulocyte Count \> 1,500/mm3 Platelet Count \> 100,000/mm3 Serum creatinine \< 2.0 x upper limit of normal (ULN) INR \< 1.5 before the start of chronic anticoagulation and a PTT within normal limits
• Liver Function Total Bilirubin less or equal to ULN AST and ALT must be \<5X ULN for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used.
• Prior radiation therapy is allowed. However, if radiation has been administered to a lesion, there must be radiographic evidence of progression of that lesion in order for that lesion to constitute measurable disease or to be included in the measured target lesions. 4 weeks must have elapsed between radiation therapy and entry into study.
• Prior vaccine therapy is allowed

You may not qualify if:

• Prior therapy with cytotoxic chemotherapy
• Prior therapy with radioisotopes
• History of brain metastasis or leptomeningeal disease
• Symptomatic neuropathy \>grade2
• Prior history of cancer (except basal cell or squamous-cell skin cancer) within the past 5 years (exceptions must be approved by the PI)
• Prior history of DVT or Pulmonary embolism in the last 1 year
• Patients must not have a serious medical illness including, but not limited to, ongoing or active infection requiring parental antibiotics; clinically significant cardiovascular disease (e.g. uncontrolled hypertension, recent myocardial infarction, unstable angina), New York heart association grade II or greater congestive heart failure, or grade II or greater peripheral arterial vascular within 1 year prior to study entry, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients must not be taking cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), rifampin or St. John's wort.
• Patients must not be taking drugs that inhibit CYP3A at the time of enrollment to prevent drug-drug interactions with docetaxel. These include ketoconazole, voriconazole, itraconazole, fluconazole, cimetidine, clarithromycin, erythromycin, troleandomycin, and grapefruit juice. These agents should be avoided during treatment while on study.
• Because patients with immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients are excluded from the study. For patients receiving combination anti-retroviral therapy, the potential impact of pharmacokinetic interactions with sorafenib and docetaxel is unknown. Appropriate studies may be undertaken in patients with HIV and those receiving combination anti-retroviral therapy in the future.
• Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Sanofi: collaborator
• Bayer: collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; 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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Ravi Amaravadi
• Organization: Abramson Cancer Center

ravi.amaravadi@pennmedicine.upenn.edu

2156622222

Study Officials

• Ravi Amaravadi, RN, MPA

  Abramson Cancer Center at Penn Medicine

  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: SPONSOR

Study Record Dates

• First Submitted: December 25, 2007
• First Posted: January 9, 2008
• Study Start: July 27, 2007
• Primary Completion: February 2, 2010
• Study Completion: February 2, 2011
• Last Updated: February 17, 2022
• Results First Posted: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)