Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Jonsson Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: paclitaxel

Drug: carboplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00049257

NCI-G02-2121

BMS-UCLA-020209201

UCLA-0202092

CDR0000258050

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. Combining more than one drug may kill more tumor cells.

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

Full description

OBJECTIVES:

Determine the prostate-specific antigen (PSA) response rate and time to PSA progression in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel and carboplatin.
Determine the objective response rate, time to measurable or evaluable disease progression, and overall survival in patients treated with this regimen.
Determine the safety and toxicity of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

Enrollment

58 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients must be informed of investigational nature of the study and written informed consent must be obtained prior to study entry
Patients >18 years of age
Patients with a histologic diagnosis of adenocarcinoma of the prostate
Patients must have metastatic disease with progression despite androgen ablation. Patients who have not undergone orchiectomy must continue LHRH analogues. For patients receiving LHRH analogues their testosterone level must be < 50ng/dL
Patients with bidimensionally measurable disease or bone metastases that is not progressive but who have a rising PSA are eligible
Patients with an ECOG performance status <2
Patients must have discontinued flutamide or nilutamide at least 4 weeks prior to the first day of treatment with evidence of progressive disease. Patients must have discontinued bicalutamide at least 6 weeks prior to registration with evidence of progressive disease
Patients with adequate hematological, renal, and hepatic function as defined by the following required laboratory values:
- While blood cell count: > 3,000/mm3
- Absolute granulocyte count: > 1,500/mm3
- Platelets: > 100,000/mm3
- Hemoglobin: > 8.5 g/dL
- Total bilirubin: < 1.5 mg/dL
- Serum creatinine: < 2.5 mg/dL
- AST or ALT: < 2.5 x institutional upper limit of normal
Patients may have received prior radiation therapy, provided at least 4 weeks have elapsed since the conclusion of radiation therapy

Exclusion criteria

Patients with biochemical only progression
Patients who have received any prior chemotherapy for cancer of the prostate
Patients who received antiandrogen therapy within 4 weeks prior to the first day of treatment after cessation of flutamide or nilutamide, and or within 6 weeks prior to registration after cessation of bicalutamide
Patients receiving concomitant chemotherapy, biologic therapy, or radiation therapy
Patients who have received Strontium 89 or other radioisotope therapies
Patients with decreasing PSA levels following antiandrogen withdrawal
Patients with > grade 1 peripheral sensory or motor neuropathy
Patients with known carcinomatous meningitis or brain metastases are excluded
Patients with past or current histories of neoplasm other than entry diagnosis except for in-situ carcinoma of any site, non-melanoma skin cancer, or other malignancy treated by surgery or radiation with a disease-free survival longer than 5 years
Patients who have undergone major surgery < 3 weeks prior to registration, except for biopsy or placement of a venous access device. Patients must have fully recovered from all effects of any prior surgery
Patients with histories of serious cardiac disease not adequately controlled: documented myocardial infarction within the last 6 months preceding registration, congestive heart failure, unstable angina, valvular disease with documented ventricular compromise, uncontrolled hypertension, arrhythmia uncontrolled by medication, clinically significant pericardial effusion
Patients with active serious infections or other serious underlying medical conditions that would otherwise impair their ability to receive protocol treatments
Patients with dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent
Patients receiving other investigational therapy
Use of any investigational agent within 30 days of first day of treatment and use of Ketoconazole, hydrocortisone, glucocorticoids, or megace within 30 days of first day of treatment or other concomitant medications