Study of Patupilone in Prostate Cancer Patients Who Progress After Hormone Therapy and Docetaxel Chemotherapy

This study has been completed.
Sponsor:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00407251
First received: November 30, 2006
Last updated: November 3, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to determine the efficacy of patupilone chemotherapy and to find out what effects (good and bad) the drug Patupilone has on patients with prostate cancer that has progressed following hormone treatment and docetaxel chemotherapy.


Condition Intervention Phase
Hormone Refractory Prostate Cancer
Drug: Patupilone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Patupilone (EPO906A) as a Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • PSA response

Secondary Outcome Measures:
  • objective response rate
  • duration of response
  • time to PSA progression
  • Time to treatment failure

Estimated Enrollment: 73
Study Start Date: February 2007
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Prostate cancer is the most common cancer diagnosed and the second most common cause of cancer death in men in North America (Jemal 2003). Many patients with localized disease have an excellent long-term survival and high cure rates with standard approaches (D'Amico 1998). However, patients with high risk, locally advanced and metastatic disease have a poor prognosis, and although hormonal therapy in the form of medical or surgical castration can induce significant long-term remissions,development of androgen independent disease is inevitable. Androgen independent (AI) disease, also termed hormone refractory prostate cancer (HRPC), is clinically detected by a rise in prostate specific antigen (PSA) and worsening of symptoms. Once patients reach this stage, therapeutic options are limited and prognosis is poor

Patients with hormone refractory prostate cancer after docetaxel chemotherapy have limited treatment options and no treatment has been proven to be efficacious. Because of the mechanism of action and the activity of anti-microtubule agents and combinations in general for HRPC, patupilone has potential for therapeutic activity in patients with HRPC that have progressed after first line docetaxel chemotherapy.

  Eligibility

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

Inclusion Criteria:

  • Patients must have histological or cytological diagnosis of adenocarcinoma of the prostate.
  • Patients must have metastatic or locally recurrent disease.
  • Patients must have documented evidence of PSA progression
  • The PSA must be > 5 ng/mL at the time of study entry.
  • ECOG performance status of 0, 1 or 2.
  • Patients must have a life expectancy of at least 12 weeks in the judgment of the investigator.
  • Chemotherapy: patients must have received prior docetaxel based chemotherapy (either as a single agent or in combination). Patients must have evidence of progression while receiving docetaxel based chemotherapy or within 6 months after the completion of docetaxel based chemotherapy. Prior adjuvant or neoadjuvant chemotherapy is permitted provided therapy was completed > 12 months prior to registration. Prior therapy with mitoxantrone or experimental non-cytotoxic chemotherapy is permitted (e.g. monoclonal antibodies, vaccine therapy, receptor tyrosine kinase inhibitors).
  • Hormonal Therapy: Prior hormone therapy is permitted. Patients must be hormone refractory and have been previously and currently treated with androgen ablative therapy (medical or surgical castration). Therapy with LHRH agonist must continue for those prostate cancer patients already receiving this treatment at the time of enrollment. If the patient has discontinued the LHRH agonist, this must be restarted and the castrate level of testosterone must be present. Patients must have discontinued any use of non-steroidal antiandrogens (e.g. bicalutamide, nilutamide, flutamide) at least 6 weeks prior to initiation of protocol therapy.
  • Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and enrollment to the trial. Exceptions may be made for low dose, nonmyelosuppressive radiotherapy after consultation with the principal investigator. Prior strontium is not permitted. Patients must have had less than 30% of marrow bearing areas irradiated.
  • Steroids: Current treatment with steroids are permitted provided the dose is less than or equivalent to a daily dose of prednisone of 20mg.
  • Laboratory Requirements - within 7 days prior to enrollment Hematology: absolute granulocytes ≥ 1.5 x 109/Lplatelets ≥ 100 x 109/Lhemoglobin ≥ 90 g/L Biochemistry: bilirubin ≤ 1.0 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal
  • Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre.

Exclusion Criteria:

  • Patients with a history of other invasive cancer, except adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for > 3 years.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Patupilone or other agents used in the study.
  • Other serious intercurrent illness of medical condition that might be aggravated by protocol treatment including: myocardial infarction within 6 months prior to study entry congestive heart failure unstable angina active cardiomyopathy unstable ventricular arrhythmia uncontrolled hypertension uncontrolled psychotic disorders serious infections active peptic ulcer disease
  • HIV-positive patients receiving combination anti-retroviral therapy
  • Peripheral neuropathy > grade 1.
  • Patients who have received treatment with other investigational agents or anti-cancer therapy < 21 days prior to date of protocol treatment.
  • Patients receiving anticoagulation with warfarin (Coumadin®).
  • Patients with grade ≥ 1 diarrhea.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407251

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T4N 4N2
Canada, British Columbia
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8B 5C2
London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Study Chair: Kim Chi, MD BC Cancer Agency - Vancouver Centre
  More Information

No publications provided

Responsible Party: Dr Kim Chi, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00407251     History of Changes
Other Study ID Numbers: OZM-005/CEPO906A2402, Protocol number CEP0906A2402, OZM-005
Study First Received: November 30, 2006
Last Updated: November 3, 2010
Health Authority: Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:
refractory
prostate
hormone

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Epothilone B
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014