Phase I trial of the combination of daily estramustine phosphate and intermittent docetaxel in patients with metastatic hormone refractory prostate carcinoma

Kreis, Willi; Budman, Daniel R.; Fetten, James; Gonzales, Alana; Barile, Barbara; Vinciguerra, Vincent

doi:10.1023/a:1008354600497

Cited by 137 publications

(69 citation statements)

References 15 publications

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“…Other phase II trials also showed similar activity for docetaxel at 75 mg/m 2 in metastatic HRPC in terms of PSA decline, objective response and pain control, with an acceptable safety profile [8][9][10][11][12]. Two phase III trials showed that it is also possible to prolong survival in patients who have metastatic HRPC if treated with docetaxel.…”

Section: Introductionmentioning

confidence: 91%

“…Mitoxantrone treatment cannot be repeated in these patients due to the potential for cardiomyopathy, which is dose-related. This, combined with the results of the previous trials [13,14] and other evidence of the antitumour activity of docetaxel in metastatic HRPC [7][8][9][10][11][12], formed the rationale for investigating the value of DP in patients who had progressed on or after MP.…”

Section: Introductionmentioning

confidence: 99%

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The Canadian Uro‐Oncology Group multicentre phase II study of docetaxel administered every 3 weeks with prednisone in men with metastatic hormone‐refractory prostate cancer progressing after mitoxantrone/prednisone

et al. 2008

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PATIENTS AND METHODSThirty patients from four centres were enrolled in the study; all had had previous MP for symptomatic, metastatic HRPC and all had castrate levels of testosterone maintained during therapy. RESULTSAt enrolment, the median age was 69 years, the mean PSA level was 324 ng/dL, and 86% of patients reported pain. There was a PSA response in 57% of the men and a reduction in pain in > 60%; the overall QoL was maintained. There were four cases of febrile neutropenia and two treatment-related deaths. The median progression-free and overall survival were 5 and 15 months, respectively. CONCLUSIONDocetaxel was associated with high rates of PSA and pain response in this study. Nonhaematological toxicity was similar to that during first-line treatment, but rates of febrile neutropenia and toxic death appeared to be slightly higher. In selected patients with progressive metastatic HRPC previously treated with mitoxantrone, docetaxel appears to be a beneficial therapeutic option. KEYWORDSprostatic neoplasms, drug therapy, docetaxel, mitoxantrone, phase II, pain Study Type -Therapy (individual cohort study) Level of Evidence 2c OBJECTIVETo investigate the use of docetaxel 75 mg/m 2 intravenously every 3 weeks plus prednisone 5 mg orally twice daily in men with metastatic hormonerefractory prostate cancer (HRPC) progressing after first-line mitoxantrone/ prednisone (MP), the primary outcome being progression-free survival with prostatic-specific antigen (PSA) and pain response, toxicity and quality of life (QoL) also assessed.

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Section: Introductionmentioning

confidence: 91%

Section: Introductionmentioning

confidence: 99%

The Canadian Uro‐Oncology Group multicentre phase II study of docetaxel administered every 3 weeks with prednisone in men with metastatic hormone‐refractory prostate cancer progressing after mitoxantrone/prednisone

et al. 2008

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“…8,14,16 Patients with CRPC who previously had discontinued DTX treatment have recently been reported to be sensitive to DTX re-treatment. 17,18 Similarly, three single-arm trials have reported that the intermittent DTX approach displays comparable efficacy in patients with CRPC; [19][20][21] however, the three trials all used weekly DTX regimens rather than a tri-weekly regimen, which has a proven benefit with an OS increase of 2.5 months compared to controls. 5,6 Two important mechanisms underlying the development and progression of CRPC, which can be exploited therapeutically, are the overexpression of IL-6 and hypersensitivity or mutation of the androgen receptor, both of which contribute to CRPC.…”

Section: Introductionmentioning

confidence: 99%

Intermittent tri-weekly docetaxel plus bicalutamide in patients with castration-resistant prostate cancer: a single-arm prospective study using a historical control for comparison

Zhang²,

Tao-tao³

et al. 2013

Asian J Androl

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Whether continuous docetaxel (DTX) chemotherapy offers an advantage over intermittent therapy for castration-resistant prostate cancer (CRPC) is unknown. In this study, we evaluated the efficacy, toxicity and quality of life (QoL) of intermittent tri-weekly DTX with bicalutamide in CRPC. Forty-two patients (group A) with CRPC were enrolled. The patients received intravenous DTX (75 mg m 22 ) once tri-weekly with oral bicalutamide (50 mg) once daily. Patients had a DTX holiday when the prostate-specific antigen (PSA) level declined o50%. DTX was restarted in patients with a PSA increase o25%. Sixty patients (group B) who had matching characteristics and had continuously received DTX without bicalutamide for 10-12 cycles were also enrolled. There were no statistically significant differences in progression-free survival (8 months vs. 9 months, P50.866) or overall survival (19 months vs. 21 months, P50.753) between groups A and B; however, the proportions of patients in group A with all grades of neutropenia (33% vs. 58%, P50.013) and nausea/vomiting (11% vs. 29%, P50.024) were significantly less compared to group B. A significant improvement in the global health and fatigue scores was recorded for group A post-chemotherapy compared to pre-chemotherapy (P,0.05). The fatigue, nausea/ vomiting and appetite loss scores in group B were increased post-chemotherapy compared to pre-chemotherapy (P,0.05). In conclusion, intermittent tri-weekly DTX plus bicalutamide is well tolerated and has the potential to achieve comparable disease control with an improvement in QoL for patients with CRPC.

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“…The most active agent preclinically and clinically was docetaxel, either alone or in combination with estramustine. [28][29][30] Docetaxel, a semisynthetic taxane, likely has multiple mechanisms of antineoplastic activity. Microtubule stabilization, the most widely accepted mechanism of action, involves binding of docetaxel to ␤-tubulin, thus promoting polymerization (Figure 3).…”

Section: Chemotherapy For Hormone Refractory Prostate Cancer: the Taxmentioning

confidence: 99%

Advances in Prostate Cancer Chemotherapy: A New Era Begins

Pienta

Smith

2005

CA: A Cancer Journal for Clinicians

163

124

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Prostate cancer continues to be the most common lethal malignancy diagnosed in American men and the second leading cause of male cancer mortality. Over 60 years ago, Huggins and Hodges discovered androgen deprivation as a first-line therapy for metastatic prostate cancer, which leads to remissions typically lasting 2 to 3 years, but in most men prostate cancer ultimately progresses to an androgen-independent state resulting in death due to widespread metastases. Multiple mechanisms of androgen independence have now been documented, including amplification of the androgen receptor as well as signal transduction pathways that bypass the androgen receptor completely. In 2004, two landmark studies demonstrated a survival advantage in androgen-independent prostate cancer patients utilizing docetaxel chemotherapy, setting a new standard of care for this disease. In addition, treatments with the bisphosphonate zoledronic acid and systemic radioisotopes have also been shown to have palliative benefits in this population. Building on these advances, several new traditional chemotherapeutic agents as well as new targeted therapies are under development. (CA Cancer J Clin 2005;55:300-318.)

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Phase I trial of the combination of daily estramustine phosphate and intermittent docetaxel in patients with metastatic hormone refractory prostate carcinoma

Cited by 137 publications

References 15 publications

The Canadian Uro‐Oncology Group multicentre phase II study of docetaxel administered every 3 weeks with prednisone in men with metastatic hormone‐refractory prostate cancer progressing after mitoxantrone/prednisone

The Canadian Uro‐Oncology Group multicentre phase II study of docetaxel administered every 3 weeks with prednisone in men with metastatic hormone‐refractory prostate cancer progressing after mitoxantrone/prednisone

Intermittent tri-weekly docetaxel plus bicalutamide in patients with castration-resistant prostate cancer: a single-arm prospective study using a historical control for comparison

Advances in Prostate Cancer Chemotherapy: A New Era Begins

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