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Study of Docetaxel +153 Sm-EDTMP in Patients With Hormone-Refractory Prostate Cancer (Tax-Sam)

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Cytogen Corporation
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00559429
First received: November 14, 2007
Last updated: December 16, 2008
Last verified: December 2008
  Purpose

The primary objective of the study is to determine a recommended phase II dose (RP2D).

The secondary objective of the study are:

  1. To evaluate preliminary incidence and duration of clinical benefits as determined by improvements of pain, PSA decline and bone scan changes.
  2. To evaluate the toxicity profile of the escalating doses of Docetaxel in combination with Samarium 153 in patients with advanced, hormone refractory prostate cancer metastatic to the bone.

Condition Intervention Phase
Prostate Cancer
Drug: Docetaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial With a Combination of Docetaxel +153 Sm-EDTMP (Samarium 153) in Patients With Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • To determine a recommended phase II dose (RP2D) [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Evaluate incidence and duration of clinical benefits as determined by improvement of pain, PSA decline and bone scan changes. Type, frequency, severity, and relationship of adverse events to escalating doses of docetaxel in combination and samarium. [ Time Frame: 6 months ]

Enrollment: 13
Study Start Date: December 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: C1 Drug: Docetaxel
Docetaxel 50mg/m2 IV on day 1 and day 22
Other Name: Samarium 153-EDTMP 1.0 mCi/kg IV on day 2
Active Comparator: C2 Drug: Docetaxel
Docetaxel 75mg/m2 IV on day 1 and day 22
Other Name: Samarium 153-EDTMP 1.0 mCi/kg IV on day 2
Active Comparator: C3 Drug: Docetaxel
Docetaxel 75mg/m2 IV on day 1 and day 22
Other Name: Samarium 153-EDTMP 1.0 mCi/kg IV on day 2
Active Comparator: C4 Drug: Docetaxel
Docetaxel 75 mg/m2 IV on day 1, 22 and day 43
Other Name: Samarium 153-EDTMP 1.0 mCi/kg IV on day 2

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients age >18 with HRPC including patients who failed conventional systemic treatments. Conventional eligibility criteria for HRPC are applicable, pain is not a requisite.
  • Histologically proven adenocarcinoma of the prostate (metastatic) that is unresponsive to hormone therapy.
  • Evidence of progressive disease following appropriate hormonal deprivation. Disease progression is defined by a confirmed PSA rise at least 1 week apart and/or evidence of disease progression on bone scan, CT scan or physical examination.
  • Evidence of progressing disease despite antiandrogen withdrawal (i.e., must have PSA rise noted >four weeks following cessation of flutamide therapy, nilandron therapy. For those patients treated with bicalutamide (Casodex), patients must have a rising PSA noted >six weeks after cessation of therapy.
  • For patients treated by medical means of gonadal ablation (GnRH analogues), or estrogens, evidence of appropriate testosterone suppression should be obtained prior to study entry (testosterone <50 ng/L). Continuation of gonadal androgen suppression should be carried out with GnRH analogues only. Antiandrogens or other steroidal compounds (except for dexamethasone used in this study) should be discontinued as noted in section 4.1.3 prior to study entry. Patients receiving low dose (<10 mg of prednisone/day) continuous corticosteroids >6 months, who present with objective evidence of disease progression may continue on the steroids (prednisone 10 mg) and are considered eligible. Prior orchiectomy is allowed and at least 4 weeks must have elapsed since completion of surgery. Patients may not be receiving Megace.
  • Patients must have metastatic disease documented within 28 days prior to study entry. X-rays, scans, and physical exam of all measurable and non- measurable disease must be completed within 28 days prior to study entry.
  • No concomitant chemotherapeutic, biological response modifiers or radiation therapy. At least 28 days must have lapsed since the last treatment with chemotherapy or biological response modifiers.
  • Patients may have received prior taxane treatment and is considered by the treating physician as a candidate for further treatment with this class of compounds.
  • ECOG performance status of 0-2 and life expectancy >3 months
  • WBC ≥3500/ mm3, ANC ≥1500/ mm3,and platelet count ≥100,000/ mm3 and hemoglobin ≥8.0 g/dl.
  • BUN <30 and serum creatinine <2.0 mg/dl.
  • Total Bilirubin <ULN, AST < 1.5 x ULN and ALT < 1.5 x ULN.
  • Recovered from major infections and/or surgical procedure and, in the opinion of the investigator, not have significant active concurrent medical illness.
  • No prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated and controlled stage I or II transitional cell carcinoma of the bladder or any other cancer from which the patient has been disease-free for 5 years.
  • Peripheral neuropathy must be <grade 1
  • Ability to understand and sign an IRB approved informed consent.
  • Patient must agree to use effective contraception from the day of initiation of treatment and for one year after completion of chemotherapy.

Exclusion Criteria:

  • Patients with a history of brain metastases.
  • Uncontrolled medical problems (neurological, cardiovascular, or other illness considered by the primary investigator as unwarranted high risk for investigational drug treatment.
  • Non adenocarcinoma cell type.
  • Known hypersensitivity to steroids, docetaxel, polysorbate 80 or Samarium153.
  • Patients who received > whole pelvic radiation for therapeutic or palliative reasons are excluded from study.
  • Peripheral neuropathy ≥ grade 1
  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: NCT00559429

Locations
United States, Maryland
The Harry and Jeanette Weinberg Building
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Sanofi
Cytogen Corporation
Investigators
Principal Investigator: Mario A. Eisenberger, M.D. Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Mario A. Eisenberger, M.D., Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00559429     History of Changes
Other Study ID Numbers: J0467, 04-09-03-03
Study First Received: November 14, 2007
Last Updated: December 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Samarium ethylenediaminetetramethylenephosphonate
Analgesics
Analgesics, Non-Narcotic
Antimitotic Agents
Antineoplastic Agents
Central Nervous System Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014