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A Study of Picoplatin and Docetaxel in Subjects With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00448734
Recruitment Status : Unknown
Verified January 2009 by Poniard Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : March 19, 2007
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
Poniard Pharmaceuticals

Brief Summary:
This study will review the safety of picoplatin, a new type of platinum drug, with docetaxel, a drug commonly used in the treatment of prostate cancer. Patients who are eligible for this study will have had a diagnosis of hormone-refractory prostate cancer that has metastasized to other areas of the body, and have not been previously treated with chemotherapy drugs. Picoplatin will be administered in combination with docetaxel and prednisone to identify the maximum tolerated dose (MTD). Patients will receive IV treatments of picoplatin with docetaxel every 3 weeks, with prednisone, 5 mg orally, twice daily.

Condition or disease Intervention/treatment Phase
Hormone Refractory Prostate Cancer Drug: Picoplatin Drug: docetaxel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of Picoplatin and Docetaxel (With Prednisone) in Subjects With Chemotherapy-Naive Metastatic Hormone-Refractory Prostate Cancer
Study Start Date : June 2006
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1

The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.

Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.

Drug: Picoplatin

The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.

Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.


Active Comparator: 2
Docetaxel
Drug: docetaxel

The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.

Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.





Primary Outcome Measures :
  1. In Part 1, the Maximum Tolerated Dose (MTD) will be determined [ Time Frame: MTD ]
  2. In Part 2, PSA response will be measured (reduction of at least 50% of PSA from baseline, with reduction maintained for at least 4 weeks) [ Time Frame: response ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: progression ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate.
  • Radiologic evidence of metastatic disease (Jewett-Whitmore Stages D1-D2 or TNM Stage N1-3 or M1).
  • Disease progression or recurrence documented by either: increasing serum PSA on three consecutive measurements each obtained at least one week apart, or findings on radiographic imaging studies.
  • Non-surgically castrate subjects must be receiving androgen ablation therapy as maintenance therapy.
  • Adequate hormonal therapy as documented by a castrate level of serum testosterone (all subjects without surgical castration must have a serum testosterone less than 50 ng/ml).
  • At least 4 weeks must have elapsed after the withdrawal of antiandrogens (6 weeks in the case of bicalutamide).
  • Age 18 years and over. Subjects older than 80 years should be entered on study only if considered "physiologically appropriate" for combination chemotherapy.
  • ECOG performance score (PS) of 0 or 1.
  • Stable levels of pain for at least 7 days before study entry.
  • Life expectancy more than 3 months.
  • At least 28 days must have elapsed since prior radiotherapy.
  • At least 28 days must have elapsed since any prior investigational agent.
  • Absolute neutrophil count (ANC) at least 1.5 x 10^9th/L.
  • Platelet count at least 100 x 10^9th/L.
  • Hemoglobin at least 10 g/dL.
  • Serum AST and ALT levels ≥ 1.5 times upper limit of normal (ULN).
  • Serum bilirubin ≤ ULN.
  • Serum creatinine ≤ ULN.
  • All subjects must agree to use appropriate birth control methods while on study and until 1 month after completion of study chemotherapy.

Exclusion Criteria:

  • Prior treatment with cytotoxic agents (except estramustine), radioisotopes, or biological therapies other than hormones.
  • Clinical evidence of brain or leptomeningeal metastases.
  • Symptomatic peripheral neuropathy of Grade 2 or higher.
  • History of another cancer within the preceding 5 years, except for superficial skin cancers.
  • Known hypersensitivity to drugs formulated with Polysorbate 80.
  • Prior radiotherapy that included ≥ 30% of the bone marrow (e.g., the whole of the pelvis or half of the spine).
  • Uncontrolled intercurrent illness (e.g., active infection).
  • Serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol.
  • History of serious cardiac disease, defined as myocardial infarction within six months of enrollment, congestive heart failure classified by the New York Heart Association as Class III or IV, uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448734


Locations
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Russian Federation
Medical Radiology Research Center under the Russian Academy of Medical Sciences
Obninsk, Kaluga Region, Russian Federation, 249036
Chelyabinsk Regional Oncology Center
Chelyabinsk, Russian Federation, 454087
Burdenko Central Military Clinical Hospital
Moscow, Russian Federation, 105229
Russian Research Center of Radiology
Moscow, Russian Federation, 117997
Research Institute of Urology - Ministry of Health
Moscow, Russian Federation
Leningrad Regional Oncology Center
St. Petersburg, Russian Federation, 188663
Central Medical Unit #122
St. Petersburg, Russian Federation, 194291
Therapeutic and Research Medical Center
St. Petersburg, Russian Federation, 194354
St. Petersburg City Hospital #26
St. Petersburg, Russian Federation, 196247
St. Petersburg City Oncology Center
St. Petersburg, Russian Federation, 198255
State Medical Institution of Yaroslavl Region / Regional Clinical Oncology Hospital
Yaroslavl, Russian Federation, 150054
Sponsors and Collaborators
Poniard Pharmaceuticals
Investigators
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Study Director: Robert Earhart, MD Poniard Pharmaceuticals

Publications:

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Responsible Party: Robert Earhart, MD, PhD, Poniard Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00448734    
Other Study ID Numbers: 0502
First Posted: March 19, 2007    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: January 2009
Keywords provided by Poniard Pharmaceuticals:
metastatic
hormone-refractory
prostate cancer
picoplatin
platinum drug
chemotherapy
docetaxel
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Prednisolone
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Antineoplastic Agents, Hormonal