Radiosensitization With Celecoxib and Chemoradiation for Head and Neck Cancer (RAD0201)
This study has been completed.
University of Alabama at Birmingham
Information provided by (Responsible Party):
Sharon Spencer, MD,, University of Alabama at Birmingham
First received: December 20, 2007
Last updated: March 13, 2013
Last verified: March 2013
Results First Received: May 30, 2012
|Study Design:||Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment|
Radiation: Radiation Therapy
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
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|Significant events and approaches for the overall study following participant enrollment, but prior to group assignment|
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|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy||Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.|
Participant Flow: Overall Study
|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
|Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.|
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|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy||No text entered.|
|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
Overall Participants Analyzed
|Between 18 and 65 years||29|
Mean (Standard Deviation)
Region of Enrollment
|1. Primary:||Toxicity of Celecoxib With Concurrent Weekly Chemotherapy and Radiotherapy in the Treatment of Locally Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck. [ Time Frame: 2 years from radiation therapy ]|
|2. Primary:||Response as Evaluated by Recurrence of Diseases [ Time Frame: 2 years from end of treatment (Radiation therapy) ]|
Limitations and Caveats
|Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data|
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Results Point of Contact:
|Principal Investigators are NOT employed by the organization sponsoring the study.|
|There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.|
Results Point of Contact:
Name/Title: Dr. Sharon Spencer Professor of Radiation Oncology
Organization: UAB Hospital
Organization: UAB Hospital
Aisner J, Sinibaldi V, Eisenberger M. Carboplatin in the treatment of squamous cell head and neck cancers. Semin Oncol. 1992 Feb;19(1 Suppl 2):60-5. Review.
Altorki, N. K., R. S. Keresztes, et al. (2002). "Celecoxib (Celebrex), a selective COX-2 inhibitor, enhances the response to preoperative paclitaxel/carboplatin in early stage non-small cell lung cancer." Proceedings of the American Society of Clinical Oncology Altorki, N. K., R. S. Keresztes, et al. (2002). "Celecoxib (Celebrex), a selective COX-2 inhibitor, enhances the response to preoperative paclitaxel/carboplatin in early stage non-small cell lung cancer." Proceedings of the American Society of Clinical Oncology Abstract 101
Bourhis J, Calais G, Eschwège F. [Chemoradiotherapy of carcinomas of the upper aerodigestive tract]. Cancer Radiother. 1998 Dec;2(6):679-88. Review. French.
Bourhis J, Eschwege F. Radiotherapy-chemotherapy combinations in head and neck squamous cell carcinoma: overview of randomized trials. Anticancer Res. 1996 Jul-Aug;16(4C):2397-402. Review.
Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804.
Chan G, Boyle JO, Yang EK, Zhang F, Sacks PG, Shah JP, Edelstein D, Soslow RA, Koki AT, Woerner BM, Masferrer JL, Dannenberg AJ. Cyclooxygenase-2 expression is up-regulated in squamous cell carcinoma of the head and neck. Cancer Res. 1999 Mar 1;59(5):991-4.
Choy H, Devore RF 3rd, Hande KR, Porter LL, Rosenblatt P, Yunus F, Schlabach L, Smith C, Shyr Y, Johnson DH. A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (a Vanderbilt Cancer Center Affiliate Network Study). Int J Radiat Oncol Biol Phys. 2000 Jul 1;47(4):931-7.
Choy H, DeVore RF 3rd, Hande KR, Porter LL, Rosenblatt P, Yunus F, Schlabach L, Smith C, Shyr Y, LaPorte K, Johnson DH. Preliminary analysis of a phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small cell lung cancer. Semin Oncol. 1997 Aug;24(4 Suppl 12):S12-21-S12-26.
Eisbruch A, Lyden T, Bradford CR, Dawson LA, Haxer MJ, Miller AE, Teknos TN, Chepeha DB, Hogikyan ND, Terrell JE, Wolf GT. Objective assessment of swallowing dysfunction and aspiration after radiation concurrent with chemotherapy for head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2002 May 1;53(1):23-8.
Eisenberger M, Hornedo J, Silva H, Donehower R, Spaulding M, Van Echo D. Carboplatin (NSC-241-240): an active platinum analog for the treatment of squamous-cell carcinoma of the head and neck. J Clin Oncol. 1986 Oct;4(10):1506-9.
Eisenberger M, Jacobs M. Simultaneous treatment with single-agent chemotherapy and radiation for locally advanced cancer of the head and neck. Semin Oncol. 1992 Aug;19(4 Suppl 11):41-6. Review.
Forastiere AA. Paclitaxel (Taxol) for the treatment of head and neck cancer. Semin Oncol. 1994 Oct;21(5 Suppl 8):49-52. Review.
Forastiere AA. Taxoids in head and neck cancer: the American approach. Acta Otorhinolaryngol Belg. 1999;53(3):253-7. Review.
Frost AR, Sparks D, Grizzle WE. Methods of antigen recovery vary in their usefulness in unmasking specific antigens in immunohistochemistry. Appl Immunohistochem Mol Morphol. 2000 Sep;8(3):236-43.
Fu KK, Pajak TF, Trotti A, Jones CU, Spencer SA, Phillips TL, Garden AS, Ridge JA, Cooper JS, Ang KK. A Radiation Therapy Oncology Group (RTOG) phase III randomized study to compare hyperfractionation and two variants of accelerated fractionation to standard fractionation radiotherapy for head and neck squamous cell carcinomas: first report of RTOG 9003. Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):7-16.
Gaffney DK, Holden J, Zempolich K, Murphy KJ, Dicker AP, Dodson M. Elevated COX-2 expression in cervical carcinoma: reduced cause-specific survival and pelvic control. Am J Clin Oncol. 2001 Oct;24(5):443-6.
Gately S. The contributions of cyclooxygenase-2 to tumor angiogenesis. Cancer Metastasis Rev. 2000;19(1-2):19-27. Review.
Grizzle, W. E., R. B. Myers, et al. (1998). Immunohistochemical evaluation of biomarkers in prostatic and colorectal neoplasia. John Walker's Methods in Molecular Medicine - Tumor Marker Protocols. M. Hanausek and Z. Walaszek. Totowa, NJ, Humana Press, Inc.: 143-160
Grizzle, W. E., R. B. Myers, et al. (1998). Factors affecting immunohistochemical evaluation of biomarker expression in neoplasia. John Walker's Methods in Molecular Medicine - Tumor Marker Protocols. M. Hanausek and Z. Walaszek. Totowa, NJ, Humana Press, Inc.: 161-180.
Gupta S, Srivastava M, Ahmad N, Bostwick DG, Mukhtar H. Over-expression of cyclooxygenase-2 in human prostate adenocarcinoma. Prostate. 2000 Jan;42(1):73-8.
Hanson WR, Houseman KA, Collins PW. Radiation protection in vivo by prostaglandins and related compounds of the arachidonic acid cascade. Pharmacol Ther. 1988;39(1-3):347-56. Review.
Hanson WR, Thomas C. 16, 16-dimethyl prostaglandin E2 increases survival of murine intestinal stem cells when given before photon radiation. Radiat Res. 1983 Nov;96(2):393-8.
Hida T, Kozaki K, Muramatsu H, Masuda A, Shimizu S, Mitsudomi T, Sugiura T, Ogawa M, Takahashi T. Cyclooxygenase-2 inhibitor induces apoptosis and enhances cytotoxicity of various anticancer agents in non-small cell lung cancer cell lines. Clin Cancer Res. 2000 May;6(5):2006-11.
Horiot JC, Le Fur R, N'Guyen T, Chenal C, Schraub S, Alfonsi S, Gardani G, Van Den Bogaert W, Danczak S, Bolla M, et al. Hyperfractionation versus conventional fractionation in oropharyngeal carcinoma: final analysis of a randomized trial of the EORTC cooperative group of radiotherapy. Radiother Oncol. 1992 Dec;25(4):231-41.
Houchen CW, Stenson WF, Cohn SM. Disruption of cyclooxygenase-1 gene results in an impaired response to radiation injury. Am J Physiol Gastrointest Liver Physiol. 2000 Nov;279(5):G858-65.
Hsu AL, Ching TT, Wang DS, Song X, Rangnekar VM, Chen CS. The cyclooxygenase-2 inhibitor celecoxib induces apoptosis by blocking Akt activation in human prostate cancer cells independently of Bcl-2. J Biol Chem. 2000 Apr 14;275(15):11397-403.
Jeremic B, Shibamoto Y, Milicic B, Nikolic N, Dagovic A, Aleksandrovic J, Vaskovic Z, Tadic L. Hyperfractionated radiation therapy with or without concurrent low-dose daily cisplatin in locally advanced squamous cell carcinoma of the head and neck: a prospective randomized trial. J Clin Oncol. 2000 Apr;18(7):1458-64.
Kawamori T, Rao CV, Seibert K, Reddy BS. Chemopreventive activity of celecoxib, a specific cyclooxygenase-2 inhibitor, against colon carcinogenesis. Cancer Res. 1998 Feb 1;58(3):409-12.
Kishi K, Petersen S, Petersen C, Hunter N, Mason K, Masferrer JL, Tofilon PJ, Milas L. Preferential enhancement of tumor radioresponse by a cyclooxygenase-2 inhibitor. Cancer Res. 2000 Mar 1;60(5):1326-31.
Kokawa A, Kondo H, Gotoda T, Ono H, Saito D, Nakadaira S, Kosuge T, Yoshida S. Increased expression of cyclooxygenase-2 in human pancreatic neoplasms and potential for chemoprevention by cyclooxygenase inhibitors. Cancer. 2001 Jan 15;91(2):333-8.
Masferrer JL, Leahy KM, Koki AT, Zweifel BS, Settle SL, Woerner BM, Edwards DA, Flickinger AG, Moore RJ, Seibert K. Antiangiogenic and antitumor activities of cyclooxygenase-2 inhibitors. Cancer Res. 2000 Mar 1;60(5):1306-11.
Munro AJ. An overview of randomised controlled trials of adjuvant chemotherapy in head and neck cancer. Br J Cancer. 1995 Jan;71(1):83-91.
Nishimura G, Yanoma S, Mizuno H, Kawakami K, Tsukuda M. A selective cyclooxygenase-2 inhibitor suppresses tumor growth in nude mouse xenografted with human head and neck squamous carcinoma cells. Jpn J Cancer Res. 1999 Oct;90(10):1152-62.
Oshima M, Dinchuk JE, Kargman SL, Oshima H, Hancock B, Kwong E, Trzaskos JM, Evans JF, Taketo MM. Suppression of intestinal polyposis in Apc delta716 knockout mice by inhibition of cyclooxygenase 2 (COX-2). Cell. 1996 Nov 29;87(5):803-9.
Pentland AP, Schoggins JW, Scott GA, Khan KN, Han R. Reduction of UV-induced skin tumors in hairless mice by selective COX-2 inhibition. Carcinogenesis. 1999 Oct;20(10):1939-44.
Petersen C, Petersen S, Milas L, Lang FF, Tofilon PJ. Enhancement of intrinsic tumor cell radiosensitivity induced by a selective cyclooxygenase-2 inhibitor. Clin Cancer Res. 2000 Jun;6(6):2513-20.
Peterson HI. Tumor angiogenesis inhibition by prostaglandin synthetase inhibitors. Anticancer Res. 1986 Mar-Apr;6(2):251-3.
Pignon JP, Bourhis J, Domenge C, Designé L. Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta-analyses of updated individual data. MACH-NC Collaborative Group. Meta-Analysis of Chemotherapy on Head and Neck Cancer. Lancet. 2000 Mar 18;355(9208):949-55.
Pillsbury HC 3rd, Webster WP, Rosenman J. Prostaglandin inhibitor and radiotherapy in advanced head and neck cancers. Arch Otolaryngol Head Neck Surg. 1986 May;112(5):552-3.
Pinto LH, Canary PC, Araújo CM, Bacelar SC, Souhami L. Prospective randomized trial comparing hyperfractionated versus conventional radiotherapy in stages III and IV oropharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):557-62.
Reddy BS, Rao CV, Seibert K. Evaluation of cyclooxygenase-2 inhibitor for potential chemopreventive properties in colon carcinogenesis. Cancer Res. 1996 Oct 15;56(20):4566-9.
Rosenthal DI, Carbone DP. Taxol plus radiation for head and neck cancer. J Infus Chemother. 1995 Spring;5(2):46-54. Review.
Ryu HS, Chang KH, Yang HW, Kim MS, Kwon HC, Oh KS. High cyclooxygenase-2 expression in stage IB cervical cancer with lymph node metastasis or parametrial invasion. Gynecol Oncol. 2000 Mar;76(3):320-5.
Sanchíz F, Millá A, Torner J, Bonet F, Artola N, Carreño L, Moya LM, Riera D, Ripol S, Cirera L. Single fraction per day versus two fractions per day versus radiochemotherapy in the treatment of head and neck cancer. Int J Radiat Oncol Biol Phys. 1990 Dec;19(6):1347-50.
Sawaoka H, Tsuji S, Tsujii M, Gunawan ES, Sasaki Y, Kawano S, Hori M. Cyclooxygenase inhibitors suppress angiogenesis and reduce tumor growth in vivo. Lab Invest. 1999 Dec;79(12):1469-77.
Schatz, S. P., L. B. Harrison, et al. (1997). Tumors of the nasal cavity and paranasal sinuses, nasopharynx, oral cavity, and oropharynx. Cancer: 741-801.
Sheng H, Shao J, Morrow JD, Beauchamp RD, DuBois RN. Modulation of apoptosis and Bcl-2 expression by prostaglandin E2 in human colon cancer cells. Cancer Res. 1998 Jan 15;58(2):362-6.
Socinski MA, Marks LB, Garst J, Sibley GS, Blackstock W, Turrisi A, Herndon J, Zhou S, Anscher M, Crawford J, Shafman T, Rosenman J. Carboplatin/paclitaxel or carboplatin/vinorelbine followed by accelerated hyperfractionated conformal radiation therapy: a preliminary report of a phase I dose escalation trial from the Carolina Conformal Therapy Consortium. Oncologist. 2001;6 Suppl 1:20-4.
Soslow RA, Dannenberg AJ, Rush D, Woerner BM, Khan KN, Masferrer J, Koki AT. COX-2 is expressed in human pulmonary, colonic, and mammary tumors. Cancer. 2000 Dec 15;89(12):2637-45.
Staar S, Rudat V, Stuetzer H, Dietz A, Volling P, Schroeder M, Flentje M, Eckel HE, Mueller RP. Intensified hyperfractionated accelerated radiotherapy limits the additional benefit of simultaneous chemotherapy--results of a multicentric randomized German trial in advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Aug 1;50(5):1161-71. Erratum in: Int J Radiat Oncol Biol Phys 2001 Oct 1;51(2):569.
Steinauer KK, Gibbs I, Ning S, French JN, Armstrong J, Knox SJ. Radiation induces upregulation of cyclooxygenase-2 (COX-2) protein in PC-3 cells. Int J Radiat Oncol Biol Phys. 2000 Sep 1;48(2):325-8.
Steinbach G, Lynch PM, Phillips RK, Wallace MH, Hawk E, Gordon GB, Wakabayashi N, Saunders B, Shen Y, Fujimura T, Su LK, Levin B, Godio L, Patterson S, Rodriguez-Bigas MA, Jester SL, King KL, Schumacher M, Abbruzzese J, DuBois RN, Hittelman WN, Zimmerman S, Sherman JW, Kelloff G. The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis. N Engl J Med. 2000 Jun 29;342(26):1946-52.
Suntharalingam M, Haas ML, Conley BA, Egorin MJ, Levy S, Sivasailam S, Herman JM, Jacobs MC, Gray WC, Ord RA, Aisner JA, Van Echo DA. The use of carboplatin and paclitaxel with daily radiotherapy in patients with locally advanced squamous cell carcinomas of the head and neck. Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):49-56.
Suntharalingam M, Haas ML, Van Echo DA, Haddad R, Jacobs MC, Levy S, Gray WC, Ord RA, Conley BA. Predictors of response and survival after concurrent chemotherapy and radiation for locally advanced squamous cell carcinomas of the head and neck. Cancer. 2001 Feb 1;91(3):548-54.
Sunwoo JB, Herscher LL, Kroog GS, Thomas GR, Ondrey FG, Duffey DC, Solomon BI, Boss C, Albert PS, McCullugh L, Rudy S, Muir C, Zhai S, Figg WD, Cook JA, Mitchell JB, Van Waes C. Concurrent paclitaxel and radiation in the treatment of locally advanced head and neck cancer. J Clin Oncol. 2001 Feb 1;19(3):800-11.
Tsujii M, Kawano S, DuBois RN. Cyclooxygenase-2 expression in human colon cancer cells increases metastatic potential. Proc Natl Acad Sci U S A. 1997 Apr 1;94(7):3336-40.
Tucker ON, Dannenberg AJ, Yang EK, Zhang F, Teng L, Daly JM, Soslow RA, Masferrer JL, Woerner BM, Koki AT, Fahey TJ 3rd. Cyclooxygenase-2 expression is up-regulated in human pancreatic cancer. Cancer Res. 1999 Mar 1;59(5):987-90.
Vokes EE, Weichselbaum RR, Mick R, McEvilly JM, Haraf DJ, Panje WR. Favorable long-term survival following induction chemotherapy with cisplatin, fluorouracil, and leucovorin and concomitant chemoradiotherapy for locally advanced head and neck cancer. J Natl Cancer Inst. 1992 Jun 3;84(11):877-82.
|Responsible Party:||Sharon Spencer, MD,, University of Alabama at Birmingham|
|ClinicalTrials.gov Identifier:||NCT00581971 History of Changes|
|Other Study ID Numbers:||
Link No: 000276825
|Study First Received:||December 20, 2007|
|Results First Received:||May 30, 2012|
|Last Updated:||March 13, 2013|
|Health Authority:||United States: Institutional Review Board