A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma: Cancer and Leukemia Group B 99813 Journal Article
| Authors: | Oh, W. K.; Halabi, S.; Kelly, W. K.; Werner, C.; Godley, P. A.; Vogelzang, N. J.; Small, E. J. |
| Article Title: | A phase II study of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor support in patients with hormone-refractory prostate carcinoma: Cancer and Leukemia Group B 99813 |
| Abstract: | BACKGROUND. The authors determined the safety and efficacy of estramustine, docetaxel, and carboplatin with granulocyte-colony-stimulating factor (G-CSF) support in patients with hormone-refractory prostate carcinoma. METHODS. In the current multicenter, cooperative group study, patients with advanced prostate carcinoma whose disease progressed despite androgen deprivation therapy were treated with a combination of oral estramustine(240 mg three times per day for 5 days), 70 mg/m2 of docetaxel, and carboplatin at a dose of (area under the curve) 5. G-CSF was used to minimize the neutropenia associated with this regimen. Each cycle was repeated every 21 days. RESULTS. Forty patients were treated with a median of 7 cycles of therapy. Of the 34 evaluable patients with elevated pretreatment prostate-specific antigen (PSA) levels, 23 (68%) had a ≥ 50% decline in PSA and 20 (59%) had a ≥ 75% decline. Twenty-one patients had measurable disease, with 1 complete response (5%) and 10 partial responses (47%), for an overall measurable response rate of 52% (95% confidence interval [95% CI], 30-74%). The most common Grade 3 or Grade 4 toxicities (according to the National Cancer Institute Common Toxicity Criteria) included neutropenia in 23% of patients, thrombocytopenia in 13%, and fatigue in 13%. Febrile neutropenia occurred in 1 patient (3%). The overall median time to disease progression was 8.1 months (95% CI, 6-10 months) and the overall survival period was 19 months (95% CI, 13-26 months). CONCLUSIONS. The combination of estramustine, docetaxel, and carboplatin with G-CSF support was found to have significant clinical activity with an acceptable toxicity profile in patients with progressive hormone-refractory prostate carcinoma. © 2003 American Cancer Society. |
| Keywords: | adult; cancer survival; controlled study; treatment outcome; aged; middle aged; survival rate; major clinical study; androgen; clinical trial; constipation; disease course; fatigue; advanced cancer; area under the curve; cancer combination chemotherapy; diarrhea; drug efficacy; drug safety; hypophosphatemia; side effect; chemotherapy; anorexia; prostate specific antigen; carboplatin; edema; controlled clinical trial; infection; liver toxicity; nephrotoxicity; phase 2 clinical trial; anemia; nausea; neuropathy; stomatitis; thrombocytopenia; antineoplastic combined chemotherapy protocols; dehydration; myalgia; weight reduction; dexamethasone; bone pain; hypercalcemia; antineoplastic activity; docetaxel; abdominal pain; dyspnea; febrile neutropenia; fever; hyperglycemia; hypomagnesemia; rash; syncope; confidence interval; prostate-specific antigen; prostatic neoplasms; chemotherapy induced emesis; disease progression; multicenter study; thrombosis; pancreatitis; warfarin; muscle weakness; taste disorder; taxoids; recombinant granulocyte colony stimulating factor; lethargy; growth factor; alopecia; granulocyte colony stimulating factor; granulocyte colony-stimulating factor; thrombotic thrombocytopenic purpura; heart muscle ischemia; prostate carcinoma; hypocalcemia; desquamation; neoplasms, hormone-dependent; progressive disease; vertigo; pharyngitis; estramustine; humans; human; male; female; priority journal; article; hormone-refractory disease; estramustine phosphate sodium |
| Journal Title: | Cancer |
| Volume: | 98 |
| Issue: | 12 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 2003-12-15 |
| Start Page: | 2592 |
| End Page: | 2598 |
| Language: | English |
| DOI: | 10.1002/cncr.11829 |
| PUBMED: | 14669278 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Export Date: 12 September 2014 -- Source: Scopus |
