Randomized Phase II Trial of Docetaxel Plus Thalidomide in Androgen-Independent Prostate Cancer

Dahut, William L.; Gulley, James L.; Arlen, Philip M.; Liu, Yinong; Fedenko, Katherine; Steinberg, Seth M.; Wright, John J.; Parnes, Howard L.; Chen, Clara C.; Jones, Elizabeth; Parker, Catherine; Linehan, W. Marston; Figg, William D.

doi:10.1200/jco.2004.05.074

Cited by 296 publications

(178 citation statements)

References 28 publications

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“…Few trials have evaluated the docetaxel and thalidomide combination, although with slightly different dosing than in our trial. A phase II trial of docetaxel 30 mg/m 2 /week for three weeks with or without thalidomide 200 mg daily in 75 patients with androgen-independent prostate cancer showed a significantly higher response rate and overall survival with the combination therapy [44,45]. Thromboembolic events occurred in 18% of patients on the combination arm as opposed to 0% of patients on the docetaxel alone arm; with the addition of thrombosis prophylaxis, no further events occurred [44].…”

Section: Discussionmentioning

confidence: 99%

“…A phase II trial of docetaxel 30 mg/m 2 /week for three weeks with or without thalidomide 200 mg daily in 75 patients with androgen-independent prostate cancer showed a significantly higher response rate and overall survival with the combination therapy [44,45]. Thromboembolic events occurred in 18% of patients on the combination arm as opposed to 0% of patients on the docetaxel alone arm; with the addition of thrombosis prophylaxis, no further events occurred [44]. Of note, all patients with a history of thromboembolic events were randomized to the thalidomide arm [46].…”

Section: Discussionmentioning

confidence: 99%

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Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles

et al. 2008

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Summary Purpose: Pre-clinical models have demonstrated the benefit of metronomic schedules of cytotoxic chemotherapy combined with anti-angiogenic compounds. This trial was undertaken to determine the toxicity of a low dose regimen using docetaxel and thalidomide. Patients and Methods: Patients with advanced solid tumors were enrolled. Thalidomide 100mg twice daily was given with escalating doses of docetaxel from 10 to 30mg/m 2 /week. One cycle consisted of 12 consecutive weeks of therapy. The maximal tolerated dose (MTD) was defined as the dose of thalidomide along with docetaxel that caused ≤grade 1 non-hematologic or ≤grade 2 hematologic toxicity for cycle one. Results: Twenty-six patients were enrolled. Doselimiting toxicities (DLTs) were bradycardia, fatigue, fever, hyperbilirubinemia, leukopenia, myocardial infarction, and neutropenia. Prolonged freedom from disease progression was observed in 44.4% of the evaluable patients. Conclusions: This anti-angiogenic regimen was well tolerated and demonstrated clinical benefit. The recommended phase II dosing schedule is thalidomide 100mg twice daily with docetaxel 25mg/m 2 /week.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles

et al. 2008

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“…Eleven patients who progressed on vaccine alone were allowed to cross over to receive docetaxel at time of progression. Median progressionfree survival on docetaxel was 6.1 months after receiving vaccine, compared with 3.7 months for patients on the same regimen of docetaxel in a historical control at the same institution [38]. This was the first clinical trial to demonstrate that docetaxel can be safely combined with vaccine without inhibiting vaccine-specific T-cell responses.…”

Section: Vaccine and Chemotherapymentioning

confidence: 90%

Enhancing efficacy of therapeutic vaccinations by combination with other modalities

Gulley

Madan

Arlen

2007

Vaccine

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Novel strategies are emerging from preclinical and clinical investigations for combining vaccines with conventional and experimental anticancer therapies. Several lines of research show that combining either radiation or certain chemotherapeutic agents with vaccine can alter the phenotype of tumor cells, rendering them more susceptible to T-cell-mediated killing. Furthermore, there is emerging data suggesting that an immune response elicited by vaccine may augment the antitumor effectiveness of subsequent therapies. This article reviews and discusses therapeutic cancer strategies that employ vaccines sequentially or in combination with conventional cytotoxic therapies such as local radiation, chemotherapy, and hormone therapy, or immunopotentiating therapies such as anti-CTLA-4 monoclonal antibodies. Preliminary results of clinical studies using these combination strategies have demonstrated a postvaccination antigen cascade, prolonged time to disease progression, and evidence of improved overall survival. Large randomized studies are currently underway to further investigate these findings.

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“…At 18 months, the overall survival rate also was improved (68% vs 43% for docetaxel alone). 45 Dandekar et al investigated the ability of the cyclooxygenase-2 inhibitor celecoxib to increase the sensitivity of apoptosis-resistant cells to docetaxel. 46 A synergistic increase in the induction of apoptosis was noted in prostate cancer cells that were treated MIB-1 indicates; VEGF; vascular endothelial growth factor; KDR, kinase insert domain-containing receptor; HIF-1, hypoxia-inducible factor 1; COX-2, cyclooxygenase-2; TUNEL, terminal transferase deoxyuridine triphosphate nick-end labeling; PSA, prostate-specific antigen; HRPC, hormone-refractory prostate cancer; PCK3145, synthetic peptide derived from prostate secretory protein 94; IL-6, interleukin 6; PR, partial response; PFS, progression-free survival; CI, confidence interval; NR, not reported; OS, overall survival.…”

Section: Nf-jbmentioning

confidence: 99%

Mechanisms of apoptosis resistance and treatment strategies to overcome them in hormone‐refractory prostate cancer

Uzzo

Haas

Crispen

et al. 2008

Cancer

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New therapeutic strategies are needed to improve treatment outcomes in men with hormone-refractory prostate cancer. A better understanding of the molecular mechanisms of cell death in response to therapeutic strategies will help avoid ineffective treatment regimens and provide a molecular basis for new therapeutic modalities targeting apoptosis-resistant forms of prostate cancer. In this review, the authors focused on the established aberrations of apoptosis in hormonerefractory prostate cancer, and they have described novel treatment strategies to overcome apoptosis resistance.

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Randomized Phase II Trial of Docetaxel Plus Thalidomide in Androgen-Independent Prostate Cancer

Cited by 296 publications

References 28 publications

Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles

Phase I trial of docetaxel and thalidomide: a regimen based on metronomic therapeutic principles

Enhancing efficacy of therapeutic vaccinations by combination with other modalities

Mechanisms of apoptosis resistance and treatment strategies to overcome them in hormone‐refractory prostate cancer

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