drugset / Trial / NCT00005847

Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

NCT00005847

RandomizedTreatment

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. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known which treatment regimen is more effective in treating metastatic prostate cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy with that of chemotherapy plus biological therapy in treating patients who have progressive or metastatic prostate cancer that has not responded to hormone therapy.

Timeline

Start
2001-04-05
Primary completion
2004-07
Completion

Publications

  • Results Dipaola RS, Manola J, Li S, et al.: A randomized phase II trial of mitoxantrone, estramustine and vinorelbine or 13-cis retinoic acid, interferon and paclitaxel in patients with metastatic hormone refractory prostate cancer: results of ECOG 3899. [Abstract] J Clin Oncol 22 (Suppl 14): A-4594, 405s, 2004.

Drugs

EvaluationDrugModalityDoseRoute
Subject Isotretinoin Other / unclassified Oral
Subject Mitoxantrone Small molecule Intravenous
Subject Paclitaxel Small molecule Intravenous
Subject Vinorelbine Small molecule Intravenous
Subject estramustine Other / unclassified Oral
Subject interferon alfa Protein / enzyme biologic Subcutaneous

Indications