Know Cancer

or
forgot password

Phase II Trial of Sunitinib Malate for the Therapy of Progressive Metastatic Androgen Independent Prostate Cancer (AIPC) Following Docetaxel-Based Chemotherapy


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Metastatic Prostate Cancer

Thank you

Trial Information

Phase II Trial of Sunitinib Malate for the Therapy of Progressive Metastatic Androgen Independent Prostate Cancer (AIPC) Following Docetaxel-Based Chemotherapy


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of progression-free survival (PFS)

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Guru Sonpavde, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research

Authority:

United States: Institutional Review Board

Study ID:

2006-0012

NCT ID:

NCT00599313

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Metastatic Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Texas Oncology, P.A.Dallas, Texas  75246
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Ocala Oncology CenterOcala, Florida  34474
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Missouri Cancer AssociatesColumbia, Missouri  65201
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Hope CenterTerre Haute, Indiana  47809
St. Joseph Oncology, Inc.Saint Joseph, Missouri  64506
New York Oncology Hematology, P.C.Albany, New York  12208
Northwest Cancer Specialists-VancouverVancouver, Washington  98684
Medical Oncology AssociatesKingston, Pennsylvania  18704
Texas Cancer Center at Medical CityDallas, Texas  75230
Allison Cancer CenterMidland, Texas  79701
Hematology Oncology AssociatesPhoenix, Arizona  85012
Greater Dayton Cancer CenterKettering, Ohio  45409
Texas Cancer CenterAbilene, Texas  79606
Texas Oncology Cancer CenterAustin, Texas  78731
Mamie McFaddin Ward Cancer CenterBeaumont, Texas  77702
Onc and Hem Associates of SW VA, Inc.Salem, Virginia  24153
Maryland Oncology Hematology, P.A.Columbia, Maryland  21044
Paris Regional Cancer CenterParis, Texas  75460
NH Oncology-Hematology PAHooksett, New Hampshire  03106
Interlakes Oncology Hematology, PCRochester, New York  14623
Texas Cancer Center-Abilene(South)Abilene, Texas  79606
El Paso Cancer Treatment CtrEl Paso, Texas  79915
Texas Oncology Cancer Center-Sugar LandSugar Land, Texas  77479
Puget Sound Cancer Center-SeattleSeattle, Washington  98133
Yakima Valley Mem Hosp/North Star LodgeYakima, Washington  98902
Puget Sound Cancer Center-EdmondsEdmonds, Washington  98026
Connecticut Oncology & Hematology, LLPTorrington, Connecticut  06790
Alliance Hematology Oncology PAWestminster, Maryland  21157
Texas Oncology, P.A.-AmarilloAmarillo, Texas  79106
HOAST-Medical Dr.San Antonio, Texas  78229
Cancer Centers of North CarolinaRaleigh, North Carolina  27607
Texas Oncology, P.A.-BedfordBedford, Texas  76022
Methodist Charlton Cancer Ctr.Dallas, Texas  75237
Texas Oncology-OdessaOdessa, Texas  79761
Texas Oncology Cancer Care and ResearchWaco, Texas  76712
Cancer Care & Hematology Specialista of ChicagolandNiles, Illinois  60714
Arch Medical Services, Inc. DBA The Cntr for Cancer Care & ResearchSt. Louis, Missouri  63141
Texas Onclogy, P.A.Dallas, Texas  75231