Phase II clinical trial of capecitabine and gemcitabine chemotherapy in patients with metastatic renal carcinoma

Waters, Justin S.; Moss, Charlotte; Pyle, L; James, Maggie; Hackett, S; A’Hern, Roger; Gore, Martin; Eisen, Tim

doi:10.1038/sj.bjc.6602209

Cited by 55 publications

(36 citation statements)

References 23 publications

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“…It is also longer than the 8 -15 months survival seen with other therapeutic agents assessed in recent studies in similar patient populations (Mekhail et al, 2005). These studies have included immunotherapy with IFN-a or IL-2 alone or in combination with established chemotherapy (Motzer and Russo, 2000); thalidomide (Clark et al, 2004), 5-FU (O'Brien et al, 2004Rathmell et al, 2004), chemotherapy; gemcitabine þ oxaplatin (Porta et al, 2004), gemcitabine þ capecitabine (Waters et al, 2004) and experimental agents such as Gefitinib (Dawson et al, 2004).…”

Section: Discussionmentioning

confidence: 99%

A phase II study of a 5T4 oncofoetal antigen tumour-targeted superantigen (ABR-214936) therapy in patients with advanced renal cell carcinoma

et al. 2007

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In a phase II study, 43 renal cell carcinoma patients were treated with individualised doses of ABR-214936; a fusion of a Fab recognising the antigen 5T4, and Staphylococcal enterotoxin A. Drug was given intravenously on 4 consecutive days, treatment was repeated 1 month later. Treatment was associated with moderate fever and nausea, but well tolerated. Of 40 evaluable patients, 28 had disease control at 2 months, and at 4 months, one patient showed partial response (PR) and 16 patients stable disease. Median survival, with minimum follow-up of 26 months was 19.7 months with 13 patients alive to date. Stratification by the Motzer's prognostic criteria highlights prolonged survival compared to published expectation. Patients receiving higher drug exposure had greater disease control and lived almost twice as long as expected, whereas the low-exposure patients survived as expected. Sustained interleukin-2 (IL-2) production after a repeated injection appears to be a biomarker for clinical effect, as the induced-IL-2 level on the day 2 of treatment correlated with survival. The high degree of disease control and the prolonged survival suggest that this treatment can be effective. These findings will be used in the trial design for the next generation of drug, with reduced antigenicity and toxicity.

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Section: Discussionmentioning

confidence: 99%

A phase II study of a 5T4 oncofoetal antigen tumour-targeted superantigen (ABR-214936) therapy in patients with advanced renal cell carcinoma

et al. 2007

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“…The median PFS was 14.7 months and the median OS 27.9 months. [24] When capecitabine is combined with another chemotherapy agent gemcitabine responses are seen in 15.8 %-22 % of patients in phase I-II studies [28,29], which is quite comparable to responses in different combinations of chemoimmunotherapy with interferon.…”

Section: Discussionmentioning

confidence: 76%

“…[22] In the four-drug combination of capecitabine, interferon-alfa-2a, IL-2 and oral 13-cis retinoic acid toxicity was mild. [23] When capecitabine is combined with gemcitabine, the combination is reported to be too toxic in phase I study despite of dose reductions [28], but in phase II study this combination had moderate and manageable toxicity [29], even when gemcitabine was given with bigger dose than in the phase I study.…”

Section: Discussionmentioning

confidence: 99%

A phase-II study of combination of pegylated interferon alfa-2a and capecitabine in locally advanced or metastatic renal cell cancer

Sunela

Koskinen

Kellokumpu-Lehtinen

2009

Cancer Chemother Pharmacol

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“…Response rates have ranged from 8.4% to 16%, stable disease rates from 48% to 67%, and median progression-free survival from 4.6 to 7.6 months. [9][10][11][12] We report two patients with metastatic RCC who achieved durable remissions after treatment with the chemotherapy regimen of gemcitabine and capecitabine after failure of targeted therapies. One patient has been in remission more than 6 years since rapid disease progression while receiving high-dose IL-2 and sorafenib.…”

Section: Discussionmentioning

confidence: 99%

Durable Remission of Metastatic Renal Cell Carcinoma With Gemcitabine and Capecitabine After Failure of Targeted Therapy

Richey

Lim

et al. 2011

JCO

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Case ReportPatient 1. A 56-year-old man presented with weight loss and hematuria. Evaluation revealed a large left renal mass with extensive retroperitoneal lymphadenopathy and caval tumor thrombus. After two cycles of high-dose bolus interleukin-2 (IL-2), he underwent total resection of his abdominal disease. Pathology revealed a 15-cm conventional (clear cell) renal cell carcinoma (RCC)-Fuhrman nuclear grade 4 -with involvement of the renal vein and left adrenal gland and intrahepatic caval tumor thrombus. Follow-up computed tomography scans showed tumor recurrence in the cava, liver, and second lumbar vertebral body (Fig 1A). He was enrolled onto a phase II study of sorafenib (BAY 43-9006; Bayer Pharmaceuticals, Wayne, NJ) 400 mg orally twice daily. After 9 weeks of therapy, imaging studies showed progression of liver metastases ( Fig 1B); he also required palliative radiation to the lumbar spine. He was then enrolled onto a phase II study of gemcitabine plus capecitabine and received gemcitabine 1,000 mg/m 2 over 30 minutes on days 1, 8, and 15 and capecitabine

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Phase II clinical trial of capecitabine and gemcitabine chemotherapy in patients with metastatic renal carcinoma

Cited by 55 publications

References 23 publications

A phase II study of a 5T4 oncofoetal antigen tumour-targeted superantigen (ABR-214936) therapy in patients with advanced renal cell carcinoma

A phase II study of a 5T4 oncofoetal antigen tumour-targeted superantigen (ABR-214936) therapy in patients with advanced renal cell carcinoma

A phase-II study of combination of pegylated interferon alfa-2a and capecitabine in locally advanced or metastatic renal cell cancer

Durable Remission of Metastatic Renal Cell Carcinoma With Gemcitabine and Capecitabine After Failure of Targeted Therapy

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