Show simple item record

Phase II trial of biweekly gemcitabine and paclitaxel with recurrent or metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group study S0329

dc.contributor.authorMalhotra, Binuen_US
dc.contributor.authorMoon, Jamesen_US
dc.contributor.authorKucuk, Omaren_US
dc.contributor.authorClark, Joseph I.en_US
dc.contributor.authorUrba, Susan G.en_US
dc.contributor.authorWolf, Gregory T.en_US
dc.contributor.authorWorden, Francis P.en_US
dc.date.accessioned2014-12-09T16:54:06Z
dc.date.availableWITHHELD_13_MONTHSen_US
dc.date.available2014-12-09T16:54:06Z
dc.date.issued2014-12en_US
dc.identifier.citationMalhotra, Binu; Moon, James; Kucuk, Omar; Clark, Joseph I.; Urba, Susan G.; Wolf, Gregory T.; Worden, Francis P. (2014). "Phase II trial of biweekly gemcitabine and paclitaxel with recurrent or metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group study S0329." Head & Neck 36(12): 1712-1717.en_US
dc.identifier.issn1043-3074en_US
dc.identifier.issn1097-0347en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/109649
dc.description.abstractBackground A phase I study and an institutional pilot study in patients with metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) utilizing biweekly gemcitabine and paclitaxel (GEMTAX), showed an overall response rate of 53%. 1 This phase II trial was conducted to determine the feasibility, tolerability, and efficacy of this combination. Methods Patients with metastatic/recurrent SCCHN were treated with gemcitabine (3000 mg/m2) and paclitaxel (150 mg/m2) on days 1 and 15 of every 28‐day cycle. Results In 57 patients with measurable disease, median progression‐free survival (PFS) was 4 months and median overall survival (OS) was 8 months. Overall response rate of 28% and disease stabilization in 19% were seen. There were no treatment‐related deaths with grade 3/4 hematologic toxicity seen in 20% of the patients. Conclusion Biweekly GEMTAX is feasible, well tolerated, and demonstrated reasonable efficacy. This may be an alternative for patients who are not candidates for platinum‐based chemotherapy. © 2014 Wiley Periodicals, Inc. Head Neck 36: 1712–1717, 2014en_US
dc.publisherWiley Periodicals, Inc.en_US
dc.subject.otherPaclitaxelen_US
dc.subject.otherGemcitabineen_US
dc.subject.otherRecurrenten_US
dc.subject.otherMetastaticen_US
dc.subject.otherSquamous Cell Carcinoma of the Head and Necken_US
dc.titlePhase II trial of biweekly gemcitabine and paclitaxel with recurrent or metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group study S0329en_US
dc.typeArticleen_US
dc.rights.robotsIndexNoFollowen_US
dc.subject.hlbsecondlevelOtolaryngologyen_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/109649/1/hed23522.pdf
dc.identifier.doi10.1002/hed.23522en_US
dc.identifier.sourceHead & Necken_US
dc.identifier.citedreferenceKaplan EL Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457 – 481.en_US
dc.identifier.citedreferenceJemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin 2009; 59: 225 – 249.en_US
dc.identifier.citedreferenceCohen EE, Lingen MW, Vokes EE. The expanding role of systemic therapy in head and neck cancer. J Clin Oncol 2004; 22: 1743 – 1752.en_US
dc.identifier.citedreferenceVermorken JB, Mesia R, Rivera F, et al. Platinum‐based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 2008; 359: 1116 – 1127.en_US
dc.identifier.citedreferenceGebbia V, Testa A, Cannata G, Gebbia N. Single agent paclitaxel in advanced squamous cell head and neck carcinoma. Eur J Cancer 1996; 32A: 901 – 902.en_US
dc.identifier.citedreferenceForastiere AA, Shank D, Neuberg D, Taylor SG IV, DeConti RC, Adams G. Final report of a phase II evaluation of paclitaxel in patients with advanced squamous cell carcinoma of the head and neck: an Eastern Cooperative Oncology Group trial (PA390). Cancer 1998; 82: 2270 – 2274.en_US
dc.identifier.citedreferenceRaguse JD, Gath HJ, Bier J, Riess H, Oettle H. Gemcitabine in the treatment of advanced head and neck cancer. Clin Oncol (R Coll Radiol) 2005; 17: 425 – 429.en_US
dc.identifier.citedreferenceKroep JR, Giaccone G, Voorn DA, et al. Gemcitabine and paclitaxel: pharmacokinetic and pharmacodynamic interactions in patients with non‐small‐cell lung cancer. J Clin Oncol 1999; 17: 2190 – 2197.en_US
dc.identifier.citedreferenceCatimel G, Vermorken JB, Clavel M, et al. A phase II study of Gemcitabine (LY 188011) in patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group. Ann Oncol 1994; 5: 543 – 547.en_US
dc.identifier.citedreferenceBrown T, O'Rourke T, Burris H, et al. A phase I trial of gemcitabine (LY 188011) administered intravenously every two weeks. Proc Am Soc Clin Oncol 1991; 10:abstract 115.en_US
dc.identifier.citedreferenceTanis BC, Clavel M, Guastalla JP, et al. Phase I study of gemcitabine (difluorodeoxycytidine; dFdC (LY 188011)) administered in a two weekly schedule. Proc Am Assoc Cancer Res 1990; 31:abstract 207.en_US
dc.identifier.citedreferenceRothenberg ML, Sharma A, Weiss GR, et al. Phase I trial of paclitaxel and gemcitabine administered every two weeks in patients with refractory solid tumors. Ann Oncol 1998; 9: 733 – 738.en_US
dc.identifier.citedreferenceAlousi AM, Fontana J, Yoo G, Kim H, Jacobs JR, Kucuk O. Phase II study of GEMTAX (gemcitabine and paclitaxel) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Proc Am Soc Clin Oncol 2003; 22:abstract 2044.en_US
dc.identifier.citedreferenceTherasse P, Arbuck SG, Eisenhauer EA, 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. J Natl Cancer Inst 2000; 92: 205 – 216.en_US
dc.identifier.citedreferenceBrookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics 1982; 38: 29 – 41.en_US
dc.identifier.citedreferenceArgiris A, Li Y, Forastiere A. Prognostic factors and long‐term survivorship in patients with recurrent or metastatic carcinoma of the head and neck. Cancer 2004; 101: 2222 – 2229.en_US
dc.identifier.citedreferenceWorden FP, Moon J, Samlowski W, et al. A phase II evaluation of a 3‐hour infusion of paclitaxel, cisplatin, and 5‐fluorouracil in patients with advanced or recurrent squamous cell carcinoma of the head and neck: Southwest Oncology Group study 0007. Cancer 2006; 107: 319 – 327.en_US
dc.identifier.citedreferenceArgiris A, Karamouzis MV, Gooding WE, et al. Phase II trial of pemetrexed and bevacizumab in patients with recurrent or metastatic head and neck cancer. J Clin Oncol 2011; 29: 1140 – 1145.en_US
dc.identifier.citedreferenceKafri Z, Heilbrun LK, Sukari A, et al. Phase II study of gemcitabine and docetaxel combination in patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck. ISRN Oncol 2012; 2012: 159568.en_US
dc.identifier.citedreferenceStier S, Koll C, Neuhaus T, et al. Gemcitabine and paclitaxel in metastatic or recurrent squamous cell carcinoma of the head and neck: a phase I‐II study. Anticancer Drugs 2005; 16: 1115 – 1121.en_US
dc.owningcollnameInterdisciplinary and Peer-Reviewed


Files in this item

Show simple item record

Remediation of Harmful Language

The University of Michigan Library aims to describe library materials in a way that respects the people and communities who create, use, and are represented in our collections. Report harmful or offensive language in catalog records, finding aids, or elsewhere in our collections anonymously through our metadata feedback form. More information at Remediation of Harmful Language.

Accessibility

If you are unable to use this file in its current format, please select the Contact Us link and we can modify it to make it more accessible to you.