DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

Theradex

Status and phase: Unknown; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: DHA-paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00024414

CDR0000068930

JHOC-01011003

PROTARGA-P01-00-04

THERADEX-P01-00-04

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Full description

OBJECTIVES:

• Determine the objective tumor response rate or prostate-specific antigen response, duration of response, and time to disease progression in patients with metastatic hormone-refractory prostate cancer treated with DHA-paclitaxel.
• Determine the overall survival of patients treated with this drug.
• Determine the toxicity profile of this drug in these patients.
• Assess the quality of life of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 2 courses, and off study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 18-50 patients will be accrued for this study.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the prostate

  • Progressive metastatic disease on continuous hormonal therapy (e.g., orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist)

  • Progressive disease is defined by all of the following:

    • Measurable disease or lesions on bone scan
    • Increases in prostate-specific antigen (PSA) levels on at least 2 consecutive measurements
    • Continued PSA elevation after cessation of prior antiandrogen therapy (4 weeks after flutamide and nilutamide and 8 weeks after bicalutamide)

• PSA level at least 5 ng/mL

• Serum testosterone level less than 50 ng/mL

  • Patients who have not undergone prior surgical castration should continue primary androgen suppression (LHRH agonist)

• No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No uncontrolled ventricular arrhythmia
• No myocardial infarction within the past 3 months
• No superior vena cava syndrome

Neurologic:

• No peripheral neuropathy greater than grade 1
• No uncontrolled major seizure disorder
• No spinal cord compression

Other:

• No psychiatric disorder that would preclude informed consent

• No unstable or serious concurrent medical condition

• No concurrent serious infection requiring parenteral therapy

• No other prior or concurrent malignancy except:

  • Curatively treated nonmelanoma skin cancer OR
  • Other cancer curatively treated with surgery alone that has not recurred for more than 5 years

• Fertile patients must use effective contraception during and for at least 6 months after study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior taxanes
• Prior mitoxantrone or prednisone for metastatic disease allowed
• At least 28 days since prior chemotherapy and recovered
• No other concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics
• No concurrent hormonal therapy

Radiotherapy:

• No prior samarium SM 153 lexidronam pentasodium or strontium chloride Sr 89
• Prior external radiotherapy for metastatic disease allowed
• At least 28 days since prior large-field radiotherapy and recovered
• No concurrent radiotherapy, including whole-brain radiotherapy for documented CNS metastasis

Surgery:

• See Disease Characteristics
• At least 14 days since prior major surgery and recovered

Other:

• No other prior nonhormonal treatment for metastatic disease
• At least 28 days since prior herbal preparations (e.g., PC-SPES) and recovered
• No other concurrent anticancer medications