A phase II study of gemcitabine and capecitabine in metastatic renal cancer: A report of Cancer and Leukemia Group B Protocol 90008

Cancer

Volumn 107, Issue 6, 2006, Pages 1273-1279

  Stadler, Walter M ^a,g   Halabi, Susan ^b   Rini, Brian ^c   Ernstoff, Marc S ^d   Davila, Enrique ^e   Picus, Joel ^f   Barrier, Robert ^b   Small, Eric J ^c  

^a UNIVERSITY OF CHICAGO MEDICAL CENTER   (United States)

^b Cancer and Leukemia Group B Statistical Center   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d NORRIS COTTON CANCER CENTER   (United States)

^e MOUNT SINAI MEDICAL CENTER   (United States)

^f WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF CHICAGO   (United States)

Author keywords

Capecitabine; Clinical trial; Gemcitabine; Phase II; Renal cell cancer

Indexed keywords

CAPECITABINE; FLUOROPYRIMIDINE; GEMCITABINE;

ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ALOPECIA; ANOREXIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLOOD CLOTTING DISORDER; BLOOD TOXICITY; BONE MARROW TOXICITY; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CREATININE BLOOD LEVEL; DIARRHEA; DIZZINESS; DRUG DOSE REDUCTION; DYSPNEA; EDEMA; EMBOLISM; ERYTHEMA MULTIFORME; EXFOLIATIVE DERMATITIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GASTRITIS; GASTROINTESTINAL SYMPTOM; HALLUCINATION; HAND FOOT SYNDROME; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HEPATITIS; HUMAN; HYPERGLYCEMIA; HYPERKALEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOXIA; KIDNEY CANCER; LIVER DISEASE; LUNG DISEASE; MAJOR CLINICAL STUDY; MALE; METASTASIS; MOTOR NEUROPATHY; MULTICENTER STUDY; NAUSEA; NEPHRECTOMY; NEUROLOGIC DISEASE; NEUTROPENIA; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PHLEBITIS; PRIORITY JOURNAL; PROTHROMBIN TIME; RISK ASSESSMENT; SENSORY NEUROPATHY; SIDE EFFECT; SKIN DISEASE; STOMATITIS; THROMBOSIS; VOMITING; WEIGHT REDUCTION;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, RENAL CELL; DEOXYCYTIDINE; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 33749032810     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.22117     Document Type: Article

References (24)

1. Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Fyfe G. High-dose aldesleukin in renal cell carcinoma: long-term survival update [see comments]. Cancer J Sci Am. 1997;3(Suppl 1):S70-S72.
2. Fyfe G, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995;13:688-696.
3. Coppin C, Porzsolt F, Kumpf J, Goldman A, Wilt T. Immunotherapy for advanced renal cell cancer. Cochrane Database Syst Rev. 2000(3):CD001425.
4. Motzer RJ, Michaelson MD, Redman BG, et al. Activity of SU11248, a multitargeted inhibitor of vascular endothelial growth factor receptor and platelet-derived growth factor receptor, in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006;24:16-24.
5. Motzer RJ, Rini BI, Michaelson MD, et al. Phase 2 trials of SU11248 show antitumor activity in second-line therapy for patients with metastatic renal cell carcinoma [abstract]. Proc Am Soc Clin Oncol. 2005;24:4508.
6. George CM, Stadler WM. The role of systemic chemotherapy in the treatment of kidney cancer. In: Figlin R, editor. Kidney Cancer. Norwell, MA: Kluwer Academic Publishers; 2003.
7. Mani S, Vogelzang NJ, Bertucci D, Stadler WM, Schilsky RL, Ratain MJ. Phase I study to evaluate multiple regimens of intravenous 5-fluorouracil administered in combination with weekly gemcitabine in patients with advanced solid tumors: a potential broadly active regimen for advanced solid tumor malignancies. Cancer. 2001;92:1567-1576.
8. Rini BI, Vogelzang NJ, Dumas MC, Wade JL 3rd, Taber DA, Stadler WM. Phase II trial of weekly intravenous gemcitabine with continuous infusion fluorouracil in patients with metastatic renal cell cancer. J Clin Oncol. 2000;18:2419-2426.
9. Desai AA, Vogelzang NJ, Rini BI, Ansari R, Krauss S, Stadler WM. A high rate of venous thromboembolism in a multiinstitutional Phase II trial of weekly intravenous gemcitabine with continuous infusion fluorouracil and daily thalidomide in patients with metastatic renal cell carcinoma. Cancer. 2002;95:1629-1636.
10. George CM, Vogelzang NJ, Rini BI, Geoffroy FJ, Kollipara P, Stadler WM. A Phase II trial of weekly intravenous gemcitabine and cisplatin with continuous infusion fluorouracil in patients with metastatic renal cell carcinoma. Ann Oncol. 2002;13:116-120.
11. Ryan CW, Vogelzang NJ, Stadler WM. A Phase II trial of intravenous gemcitabine and 5-fluorouracil with subcutaneous interleukin-2 and interferon-alpha in patients with metastatic renal cell carcinoma. Cancer. 2002;94:2602-2609.
12. Stadler WM, Huo D, George C, et al. Prognostic factors for survival with gemcitabine plus 5-fluorouracil based regimens for metastatic renal cancer. J Urol. 2003;170(4 Pt 1):1141-1145.
13. Kish JA, Wolf M, Crawford ED, et al. Evaluation of low dose continuous infusion 5-fluorouracil in patients with advanced and recurrent renal cell carcinoma. A Southwest Oncology Group study. Cancer. 1994;74:916-919.
14. Rini BI, Weinberg V, Small EJ. A Phase I trial of fixed dose rate gemcitabine and capecitabine in metastatic renal cell carcinoma. Cancer. 2005;103:553-558.
15. Waters JS, Moss C, Pyle L, et al. Phase II clinical trial of capecitabine and gemcitabine chemotherapy in patients with metastatic renal carcinoma. Br J Cancer. 2004;91:1763-1768.
16. Schilsky RL, Bertucci D, Vogelzang NJ, Kindler HL, Ratain MJ. Dose-escalating study of capecitabine plus gemcitabine combination therapy in patients with advanced cancer. J Clin Oncol. 2002;20:582-587.
17. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada [see comments]. J Natl Cancer Inst. 2000;92:205-216.
18. Fleming TR. One-sample multiple testing procedure for Phase II clinical trials. Biometrics. 1982;38:143-151.
19. Motzer RJ, Bacik J, Schwartz LH, et al. Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma. J Clin Oncol 2004;22:454-463.
20. Escudier B, Szczylik C, Eisen T, et al. Randomized Phase III trial of the multi-kinase inhibitor sorafenib (BAY 43-9006) in patients with advanced renal cell carcinoma [abstract 794]. Eur J Cancer Suppl. 2005;3:226.
21. Motzer RJ, Mazumdar M, Bacik J, Berg W, Amsterdam A, Ferrara J. Survival and prognostic stratification of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999;17:2530-2540.
22. Nanus DM, Garino A, Milowsky MI, Larkin M, Dutcher JP. Active chemotherapy for sarcomatoid and rapidly progressing renal cell carcinoma. Cancer. 2004;101:1545-1551.
23. Bocci G, Danesi R, Marangoni G, et al. Antiangiogenic versus cytotoxic therapeutic approaches to human pancreas cancer: an experimental study with a vascular endothelial growth factor receptor-2 tyrosine kinase inhibitor and gemcitabine. Eur J Pharmacol. 2004;498(1-3):9-18.
24. Bruns CJ, Shrader M, Harbison MT, et al. Effect of the vascular endothelial growth factor receptor-2 antibody DC101 plus gemcitabine on growth, metastasis and angiogenesis of human pancreatic cancer growing orthotopically in nude mice. Int J Cancer. 2002;102:101-108.