Mode
Text Size
Log in / Sign up
Phase 2 N=58 Treatment

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

Prostate Cancer

Enrolled (actual)
58
Serious AEs
24.1%
Results posted
Mar 2012
Primary outcome: Primary: Prostate-specific Antigen (PSA) Response Rate — 28; 30 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
carboplatin (Drug); paclitaxel (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
Jonsson Comprehensive Cancer Center
Primary completion
Mar 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Prostate-specific Antigen (PSA) Response Rate
28; 30
PRIMARY
Time to PSA Progression
115
SECONDARY
Objective Response Rate
1; 12; 33; 7
SECONDARY
Overall Survival Rate
46; 1; 1; 10

Summary

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.

Eligibility Criteria

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 3,000/mm3
  • Absolute granulocyte count: > 1,500/mm3
  • Platelets: > 100,000/mm3
  • Hemoglobin: > 8.5 g/dL
  • Total bilirubin: 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00049257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search