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Tandutinib in Treating Patients With Progressive Prostate Cancer and Bone Metastases
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00390468
  Purpose

RATIONALE: Tandutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well tandutinib works in treating patients with progressive prostate cancer and bone metastases.


Condition Intervention Phase
Metastatic Cancer
Pain
Prostate Cancer
Drug: tandutinib
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: 1-Piperazinecarboxamide, 4-(6-methoxy-7-(3-(1-piperidinyl)propoxy)-4-quinazolinyl)-N-(4-(1-methylethoxy)phenyl)-
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study of Tandutinib (MLN518) in Androgen-Independent Prostate Cancer With Bone Metastases

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prostate-specific antigen (PSA) decline rate by 50% (PSA response) [ Designated as safety issue: No ]
  • Toxicity (qualitative and quantitative) [ Designated as safety issue: Yes ]
  • Bone marker changes [ Designated as safety issue: No ]
  • Bone pain as assessed by the Brief Pain Inventory (BPI) at baseline, course 3, and progression [ Designated as safety issue: No ]
  • Objective tumor response [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2006
Estimated Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the time to progression in patients with progressive androgen-independent prostate cancer with bone metastases treated with tandutinib.

Secondary

  • Determine the prostate-specific antigen (PSA) decline rate by 50% (PSA response), using the PSA Working Group Criteria, in patients treated with this regimen .
  • Evaluate modulation of bone pain and bone markers in patients treated with this regimen.
  • Determine the objective tumor response by RECIST criteria in patients treated with this regimen.
  • Determine the qualitative and quantitative toxicity of this regimen in these patients.

OUTLINE: Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Bone pain is assessed at baseline, on day 1 of course 3, and at disease progression.

After completion of study treatment, patients are followed for 4 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate

    • Androgen-independent disease
  • Progressive disease, as evidenced by any of the following:

    • Progressive bone pain from bone metastases
    • Increasing bidimensional disease on clinical examination or x-rays
    • Appearance of new lesions on bone radiographs
    • Prostate-specific antigen (PSA) progression, defined as 2 consecutive rises in PSA, each an absolute change of ≥ 1 ng/mL, measured ≥ 2 weeks apart
  • Radiological evidence of bone metastases
  • Must have castrate level of testosterone (< 50 ng/mL)

    • If medically castrated, must continue luteinizing hormone-releasing hormone analog to maintain testicular suppression
  • PSA ≥ 5 ng/mL
  • Received at least 1 prior taxane-based regimen
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Creatinine normal OR creatinine clearance ≥ 40 mL/min
  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment
  • Mean QTc ≤ 500 msec (with Bazett's' correction)
  • No history of familial long QT syndrome
  • LVEF ≥ 40 %
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia
  • No ongoing uncontrolled vomiting or nausea ≥ grade 2
  • No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs the ability to swallow pills or absorb oral medications
  • No history of chronic liver disease
  • No known or suspected primary muscular or neuromuscular disease (e.g., muscular dystrophy or myasthenia gravis)
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tandutinib
  • No uncontrolled intercurrent illness, including, but not limited to, the following:

    • Ongoing or active infections, defined as requiring IV antibiotics on day 1 of treatment
    • Psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior known platelet-derived growth factor receptor inhibitor (e.g., imatinib mesylate, sunitinib malate, or sorafenib) therapy
  • At least 4 weeks since prior anti-androgens (6 weeks for bicalutamide), unless interim evidence of progression
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
  • No other concurrent investigational agents or hormonal therapy (unless used to maintain medical castration)

    • Glucocorticoid therapy for intercurrent medical illnesses (e.g., asthma, chronic obstructive pulmonary disease, or rheumatoid arthritis flare) allowed
  • No concurrent agents that cause QTc prolongation
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390468

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Paul Mathew M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000504104, MDA-2005-0717, NCI-7409
Study First Received: October 18, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00390468  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
pain
adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer
bone metastases

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Neoplasm Metastasis
Urogenital Neoplasms
Pain
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009