Phase II Sunitinib Prog Met AIPC

US Oncology Network

Status and phase

Completed

Phase 2

Conditions

Metastatic Prostate Cancer

Treatments

Drug: Sunitinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00599313

2006-0012 (Other Identifier)

05112

Details and patient eligibility

About

The purpose of this research study is to find out what effects (good and bad) Sutent has on you and your prostate cancer.

Full description

The following rationale can be made for a Phase II trial to evaluate sunitinib malate (Sutent) for the therapy of progressive metastatic androgen-independent prostate cancer (AIPC) following prior docetaxel chemotherapy. Since most patients with metastatic AIPC following prior chemotherapy clinically progress rapidly, we believe that achieving a 30% freedom from clinical progression (PFS) (not including PSA progression) at 12 weeks represents biologically active therapy. Sunitinib malate (Sutent) represents a tolerable and convenient form of therapy with the potential for improving outcomes in AIPC.

Enrollment

36 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A patient will be eligible for inclusion in this study if he meets all of the following criteria:
Histologically confirmed, adenocarcinoma of the prostate
Stage IV(metastatic) disease, documented on CT, MRI, or X-ray
Progressive disease (PSA or clinical): PSA progression defined as baseline increase followed by any serial increase after 2 weeks; clinical progression by symptomatic or radiologic criteria.
An elevated PSA level of for patients progressing by PSA criteria is required
Currently on androgen ablation hormone therapy (an LHRH agonist or orchiectomy) with testosterone level <50ng/dL)
Has received 1 or 2 prior chemotherapy regimens (no more than 2). One prior regimen must be docetaxel.
Has an ECOG Performance Status (PS) 0-2
Is greater than 18 years of age
Meets protocol defined laboratory values
Has adequate cardiac function in the opinion of the Investigator
Has no uncontrolled arrhythmia or hypertension
Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to NCI CTCAE Version 3.0 Grade less than 1, in the opinion of the Treating Physician
If fertile, patient has agreed to use an acceptable method of birth control to prevent pregnancy for the duration of the study and for a period of 2 months thereafter
Has signed a Patient Informed Consent Form
Has signed a Patient Authorization Form

Exclusion criteria

A patient will be excluded from this study if he meets any of the following criteria:
Has any disease other than that described in inclusion criterion #1
Had prior treatment with Sutent
Has not received prior docetaxel for the current disease
Has received any prior radionuclide therapy
Has received prior radiation to >50% of the bone marrow
Is receiving concurrent immunotherapy
Has a history of hypersensitivity to any of the components of Sutent: mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate as inactive ingredients. The orange gelatin capsule shells contain titanium dioxide, and red iron oxide. The caramel gelatin capsule shells also contain yellow iron oxide and black iron oxide. The printing ink contains shellac, propylene glycol, sodium hydroxide, povidone and titanium dioxide.
Has had significant bleeding in previous 4 weeks
Has had any of the following within the prior 6 months: severe/unstable angina, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, transient ischemic attack, or pulmonary embolism
Is receiving concurrent bisphosphonate therapy; long-standing bisphosphonate therapy (initiated >8 weeks prior to registration) is acceptable. Bisphosphonates started within the prior 8 weeks will not be allowed since this may affect other study endpoints and render their interpretation difficult
Has received treatment with radiation therapy, surgery, chemotherapy, ketoconazole, corticosteroids, or an investigational agent within 4 weeks prior to registration, (6 weeks for radiation therapy, nitrosureas or Mitomycin C)
Has uncontrolled arrhythmia or hypertension
Has evidence of uncontrolled CNS involvement (previous radiation and off steroids is acceptable)
Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin), which could affect the diagnosis or assessment of any of the study drugs
Is unable to comply with requirements of study