DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theradex
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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