Study of Docetaxel +153 Sm-EDTMP in Patients With Hormone-Refractory Prostate Cancer

NCT00559429 | Completed Phase 1 DMC

• 2 other identifiers: J046704-09-03-03
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 1.To evaluate preliminary incidence and duration of clinical benefits as determined by improvements of pain, PSA decline and bone scan changes.
2. 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To determine a recommended phase II dose (RP2D)

  6 months

Secondary Outcomes (1)

• 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.

  6 months

Study Arms (4)

C1

ACTIVE COMPARATOR

Drug: Docetaxel

C2

ACTIVE COMPARATOR

Drug: Docetaxel

C3

ACTIVE COMPARATOR

Drug: Docetaxel

C4

ACTIVE COMPARATOR

Drug: Docetaxel

Interventions

Docetaxel DRUG

Docetaxel 50mg/m2 IV on day 1 and day 22

Also known as: Samarium 153-EDTMP 1.0 mCi/kg IV on day 2

C1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Sanofi: collaborator
• Cytogen Corporation: collaborator

Study Sites (1)

The Harry and Jeanette Weinberg Building

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Mario A. Eisenberger, M.D.

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: December 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 17, 2008

Record last verified: 2008-12

Locations

US (1)