A Study of Picoplatin and Docetaxel in Subjects With Prostate Cancer

Phase 1

• Conditions: Hormone Refractory Prostate Cancer
• Interventions: Drug: docetaxel; Drug: Picoplatin

• Registration Number: NCT00448734
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-03-15
• Study First Submitted QC: 2007-03-15
• Study First Posted: 2007-03-19
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-20
• Last Update Posted: 2009-01-21
• Primary Completion: 2009-12
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 95

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	docetaxel	Docetaxel
1	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.

Primary Outcome Measures

Name	Time	Method
In Part 1, the Maximum Tolerated Dose (MTD) will be determined	MTD
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)	response

Secondary Outcome Measures

Name	Time	Method
Progression free survival	progression

Trial Locations

Locations (11)

Medical Radiology Research Center under the Russian Academy of Medical Sciences; 🇷🇺 Obninsk, Kaluga Region, Russian Federation

Leningrad Regional Oncology Center; 🇷🇺 St. Petersburg, Russian Federation

St. Petersburg City Hospital #26; 🇷🇺 St. Petersburg, Russian Federation

St. Petersburg City Oncology Center; 🇷🇺 St. Petersburg, Russian Federation

Burdenko Central Military Clinical Hospital; 🇷🇺 Moscow, Russian Federation

Research Institute of Urology - Ministry of Health; 🇷🇺 Moscow, Russian Federation

State Medical Institution of Yaroslavl Region / Regional Clinical Oncology Hospital; 🇷🇺 Yaroslavl, Russian Federation

Chelyabinsk Regional Oncology Center; 🇷🇺 Chelyabinsk, Russian Federation

Russian Research Center of Radiology; 🇷🇺 Moscow, Russian Federation

Central Medical Unit #122; 🇷🇺 St. Petersburg, Russian Federation

Therapeutic and Research Medical Center; 🇷🇺 St. Petersburg, Russian Federation