Sorafenib in Hormone Naïve Biochemical Recurrence of Prostate Cancer

NCT00694291 | Withdrawn Phase 2 DMC

• 1 other identifier: FCCC 07-038
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the benefit of sorafenib in patients with a rising PSA after treatment with radiation therapy or surgery who are NOT receiving with androgen ablation therapy.

Conditions

Prostate Cancer

Keywords

Rising PSA

Outcome Measures

Primary Outcomes (1)

• To compare the median PSA slope of patients with non-castrate, high risk biochemical recurrence of prostate cancer following definitive local therapy treated with Sorafenib for six months compared to those treated with placebo.

  6 months

Secondary Outcomes (3)

• To determine the response rate based on PSA criteria and duration of PSA response.

  6 months

• To compare the time to PSA progression between the Sorafenib arm and the placebo arm.

  6 months

• To document the safety and tolerability of Sorafenib in this patient population.

  6 months

Study Arms (2)

1

EXPERIMENTAL

Sorafenib 400 mg orally twice daily

Drug: Sorafenib

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Sorafenib DRUG

400 mg orally twice daily

Also known as: Nexavar

1

Placebo DRUG

Matching Placebo

2

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate
• Prior definitive treatment with radical prostatectomy and/or radiation therapy (external beam or brachytherapy). Patients may have received post prostatectomy radiation therapy in the adjuvant setting or for biochemical recurrence.
• Hormone sensitive prostate cancer as evidence by a serum total testosterone level within the institution's normal range £4 weeks of registration. (Patients may have received hormonal therapy in the adjuvant setting provided the last dose was ³ one year from the date of enrollment.)
• All patients must have evidence of biochemical progression as determined by 3 PSA measures. (PSA-2, PSA-1 and PSA 0) The most recent PSA value (PSA0) will serve as the baseline. All of these PSA values must be obtained at the same reference lab and the earliest (PSA-2) ≥ eight weeks prior to registration, but ≤ six months prior to enrollment.
• The most recent PSA value (PSA 0) must be drawn £ seven days of treatment and must be greater than 0.4 ng/ml (after prostatectomy) or greater than ³1.5 ng ml (after radiation therapy) at the time of registration.
• The patient must be at high risk for developing distant metastases by one of the following criteria:
• Gleason score 8-10 on original tumor specimen or
• Prostate specific antigen doubling time (PSADT) less than nine months calculated using the following formula PSADT in days = 0.693 (t) ln( PSA-1)-ln (PSA-2)
• where t = number of days between PSA- 2 and PSA-1 PSA-1 is the most recent PSA value PSA-2 is the next most recent PSA value Ln = natural log PSADT in months = PSADT divided by 30.4
• Age \> 18 years old
• ECOG Performance Status 0 or 1
• Adequate bone marrow, liver and renal function as assessed by the following:
• Hemoglobin \> 9.0 g/dl
• Absolute neutrophil count (ANC) \> 1,500/mm3
• Platelet count \> 100,000/mm3

You may not qualify if:

• Therapy modulating testosterone levels (such as leuteinizing-hormone releasing hormone agonists/antagonists and antiandrogens) for treatment of biochemical recurrence of prostate cancer. Treatment in the neoadjuvant setting is permissible if greater than 1 year prior to registration. Agents such as 5 alpha reductase inhibitors, ketoconazole, megestrol acetate, systemic steroids, or herbal supplements that are known to affect PSA (PC Spes, saw palmetto oil) are not permitted at any time during the period that the PSA values are being collected during screening or treatment
• Evidence of measurable or evaluable metastatic disease on chest x-ray bone scan or CT scan performed ≤ four weeks of registration.
• Patients must not have received any other investigational agents or concurrent anti cancer therapy £4 weeks from treatment.
• Cardiac disease: Congestive heart failure \> class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began ≤ the last 3 months) or myocardial infarction ≤ the past 6 months.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Sorafenib. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies may be undertaken in patients receiving combination antiretroviral therapy in the future
• Active clinically serious infection \> CTCAE Grade 2.
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks ≤ the past 6 months.
• Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 £4 weeks of registration.
• Any other hemorrhage/bleeding event \>CTCAE Grade 3 £ 4 weeks of registration.
• Evidence or history of bleeding diathesis or coagulopathy
• Major surgery, open biopsy or significant traumatic injury ≤ 4 weeks of registration.
• Concurrent use of cytochrome P450 enzyme inducing antiepileptic drugs (phenytoin, carbamazepine, and phenobarbital), rifampin or St Johns Wort. Patients must have discontinued these medications ³14 days from starting protocol therapy

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• Bayer: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, 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

Study Officials

• Yu-Ning Wong, MD MSCE

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 10, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2010
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (1)