An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer

NCT00748358 | Completed Phase 2 DMC

• 1 other identifier: P070404
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

as second-line treatment in metastatic prostate cancer, the present study will investigate the efficacy of sunitinib (SUTENT) given orally at a dose of 37.5 mg continuously, for 6 cycles of 6 consecutive weeks .Patients who are still responders after 6 cycles will be treated until disease progression, pain progression, unacceptable toxicity or death due to any cause. Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability. Follow-up for up to 1 year from the last dose of sunitinib.

Conditions

Prostatic Neoplasms; Neoplasms, Hormone-Dependent; Tumor Markers, Biological; Survival Rate; Disease-Free Survival

Keywords

metastatic prostate carcinoma; sunitinib [Substance Name]; Clinical Trial, Phase II [Publication Type]

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS) defined as the time from start of study treatment to first documentation of objective progressive disease, pain progression or to death on-study due to any cause.

  18 months

Secondary Outcomes (1)

• Incidence and intensity of Adverse Events (NCI CTCAE version 3.0).

  9 months

Study Arms (1)

drug

EXPERIMENTAL

drug

Drug: sunitinib

Interventions

sunitinib DRUG

37.5 mg orally once daily, continuously, for 6 cycles of 6 consecutive weeks.Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.

drug

Eligibility Criteria

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

You may qualify if:

• Signed and dated IRB/EC-approved informed consent
• Age 18 years or older
• Histologically confirmed prostate adenocarcinoma
• Metastatic HRPC
• Received prior castration by orchidectomy and/or LH-RH agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents.
• Tumor disease must be progressive after a first line using docetaxel based chemotherapy, eventually in association with estramustine. Docetaxel based regimen may have been interrupted and restarted. Patient must have either measurable (RECIST criteria) or non-measurable (bone) disease and/or clinical progression (bone pain) and/or biological progression (PSA Working Group criteria).
• Discontinuation from previous chemotherapy and/or radiation therapy at least 4 weeks prior to treatment initiation
• Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
• Patient of child bearing potential must use effective contraception. Female partners of treated patients with child bearing potential must use oral contraceptives or intra uterine device (IUD)
• Life expectancy of at least 3 months
• Resolution of all acute toxic effects of any prior local treatment to NCI CTCAE grade 1
• Patients must have adequate organ functions defined
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• Patient covered by the National Health System

You may not qualify if:

• Prior treatment with sunitinib or other antiangiogenic agent
• More than 1 line of chemotherapy
• External beam radiotherapy for ≥ 50% of bone marrow
• Uncontrolled hypertension (systolic blood pressure \> 150 mm Hg or diastolic blood pressure \> 90 mm Hg despite optimal medical management)
• Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, thrombotic or embolic events such as cerebrovascular accident including transient ischemic attack
• Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade
• Treatment with anticonvulsant agents and treatment with therapeutic doses of coumarin-derivative anticoagulants such as warfarin currently or within 2 weeks prior to first day of Sunitinib administration. Low dose of warfarin for deep vein thrombosis prophylaxis is permitted (up to 2 mg/day) and low molecular weight heparin is allowed
• Any medical condition that might interfere with oral medication absorption
• Known or suspected brain metastasis, or carcinomatous meningitis, or spinal cord compression
• Diagnosis of any second malignancy within the last 3 years, with the exception of treated basal cell or squamous cell carcinoma and pT1/a bladder cancer with no evidence of recurrent disease for 12 months
• Any acute or chronic medical or psychiatric disorder incompatible with the study
• Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness
• Treatment with others investigational drugs or participation in another clinical trial within the past 4 weeks, or concomitantly with this trial

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service Oncologie Médicale, Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms, Hormone-Dependent

Interventions

Sunitinib

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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• stephane OUDARD, professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

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: September 5, 2008
• First Posted: September 8, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: September 18, 2013

Record last verified: 2008-09

Locations

FR (1)