A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer

Gynecologic Oncology

Volumn 113, Issue 2, 2009, Pages 195-199

  Alvarez, Edwin A ^a   Wolfson, Aaron H ^b   Pearson, J Matt ^b   Crisp, Meredith P ^c   Mendez, Luis E ^d   Lambrou, Nicholas C ^e   Lucci III, Joseph A ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF MIAMI   (United States)

^c RUTGERS ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^d South Florida Gynecologic Oncology   (United States)

^e MIAMI CANCER INSTITUTE   (United States)

Author keywords

Cervical cancer; Chemotherapy; Docetaxel; Phase I; Radiation therapy

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATININE; DOCETAXEL; RADIOSENSITIZING AGENT;

ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ANXIETY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BILIRUBIN BLOOD LEVEL; BLOOD TOXICITY; BONE MARROW EXAMINATION; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER STAGING; CLINICAL ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL; COMPUTER ASSISTED TOMOGRAPHY; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CYSTITIS; CYSTOSCOPY; DIARRHEA; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; EXTERNAL BEAM RADIOTHERAPY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; GRANULOCYTE; HUMAN; HUMAN TISSUE; INTESTINE OBSTRUCTION; KIDNEY FUNCTION; LEUKOCYTE COUNT; LIVER FUNCTION; LYMPHADENECTOMY; MAXIMUM TOLERATED DOSE; MULTIMODALITY CANCER THERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; NECROTIC TUMOR; NEUROPATHY; PANCYTOPENIA; PHASE 1 CLINICAL TRIAL; PHYSICAL EXAMINATION; PNEUMONIA; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PYELOGRAPHY; RADIATION DOSE FRACTIONATION; RECOMMENDED DRUG DOSE; RECTOSCOPY; SIDE EFFECT; SQUAMOUS CELL CARCINOMA; STOMATITIS; THORAX RADIOGRAPHY; THROMBOCYTE COUNT; THROMBOCYTOPENIA; TREATMENT RESPONSE; TUMOR BIOPSY; URETER OBSTRUCTION; UTERINE CERVIX CANCER;

ADULT; AGED; ANTINEOPLASTIC AGENTS; CARCINOMA, SQUAMOUS CELL; COMBINED MODALITY THERAPY; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM STAGING; RADIATION-SENSITIZING AGENTS; TAXOIDS; UTERINE CERVICAL NEOPLASMS;

EID: 63749107733     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2008.12.033     Document Type: Article

References (47)

1. Parkin D.M., Bray F., Ferlay J., and Pisani P. Global cancer statistics, 2002. CA Cancer J. Clin. 55 2 (2005) 74-108 Mar-Apr
2. Jemal A., Siegel R., Ward E., Murray T., Xu J., and Thun M.J. Cancer statistics, 2007. CA Cancer J. Clin. 57 1 (2007) 43-66 Jan-Feb
3. Loizzi V., Cormio G., Loverro G., Selvaggi L., Disaia P.J., and Cappuccini F. Chemoradiation: a new approach for the treatment of cervical cancer. Int. J. Gynecol. Cancer 13 5 (2003) 580-586 Sep-Oct
4. Rose P.G. Concurrent chemoradiation for locally advanced carcinoma of the cervix: where are we in 2006?. Ann. Oncol. 17 Suppl 10 (2006) x224-x229 Sep
5. Green J., Kirwan J., Tierney J., Vale C., Symonds P., Fresco L., et al. Concomitant chemotherapy and radiation therapy for cancer of the uterine cervix. Cochrane Database Syst. Rev. 3 (2005) CD002225 Jul 20
6. Nieves-Neira W, Lambrou N, Davis K, Ghurani G, Mendez L, Mirhashemi R, Wolfson A, Penalver M. Major complications associated with cisplatin radiosensitization for the treatment of cervical carcinoma. Poster presentation at the Thirty-Third Annual Meeting of the Society of Gynecologic Oncologists, March 16-20, 2002. Abstract 147.
7. Ringel I., and Horwitz S.B. Studies with RP 56976 (Taxotere): a semisynthetic analogue of taxol. J. Natl. Cancer Inst. 83 4 (1991) 288-291 Feb 20
8. Guéritte-Voegelein F., Guénard D., Lavelle F., Le Goff M.T., Mangatal L., and Potier P. Relationships between the structure of taxol analogues and their antimitotic activity. J. Med. Chem. 34 3 (1991) 992-998 Mar
9. Chaffey J.T., and Hellman S. Differing responses to radiation of murine bone marrow stem cells in relation to the cell cycle. Cancer Res. 31 11 (1971) 1613-1615 Nov
10. Choy H., Rodriguez F., Wilcox B., et al. Radiation sensitizing effects of Taxotere. Proc. Am. Assoc. Cancer Res. 33 (1992) 500 (abstract 2991)
11. Hennequin C., Giocanti N., and Favaudon V. Interaction of ionizing radiation with paclitaxel (Taxol) and docetaxel (Taxotere) in HeLa and SQ20B cells. Cancer Res. 56 8 (1996) 1842-1850 Apr 15
12. Hennequin C., Giocanti N., and Favaudon V. S-phase specificity of cell killing by docetaxel (Taxotere) in synchronised HeLa cells. Br. J. Cancer 71 6 (1995) 1194-1198 Jun
13. ® Prescribing Information (2007), sanofi-aventis U.S. LLC, Bridgewater, NJ March
14. Koukourakis M.I., Bahlitzanakis N., Froudarakis M., Giatromanolaki A., Georgoulias V., Koumiotaki S., et al. Concurrent conventionally factionated radiotherapy and weekly docetaxel in the treatment of stage IIIb non-small-cell lung carcinoma. Br. J. Cancer 80 11 (1999) 1792-1796 Aug
15. Mauer A.M., Masters G.A., Haraf D.J., Hoffman P.C., Watson S.M., Golomb H.M., et al. Phase I study of docetaxel with concomitant thoracic radiation therapy. J. Clin. Oncol. 16 1 (1998) 159-164 Jan
16. Choy H., De Vore R.F., Hande K.R., Porter L.L., Rosenblatt P.A., Slovis B., et al. A phase i trial of outpatient weekly docetaxel and concurrent radiation therapy for stage III unresectable non small-cell lung cancer: a Vanderbilt Cancer Center Affiliate Network (VCCAN) trial. Clin. Lung Cancer 1 Suppl 1 (2000) S27-S31 Apr
17. Viret F., Ychou M., Goncalves A., Moutardier V., Magnin V., Braud A.C., et al. Docetaxel and radiotherapy and pancreatic cancer. Pancreas 27 3 (2003) 214-219 Oct
18. Karasawa K., Katsui K., Seki K., Kohno M., Hanyu N., Nasu S., et al. Radiotherapy with concurrent docetaxel for advanced and recurrent breast cancer. Breast Cancer 10 3 (2003) 268-274
19. Kumar P., Perrotti M., Weiss R., Todd M., Goodin S., Cummings K., et al. Phase I trial of weekly docetaxel with concurrent three-dimensional conformal radiation therapy in the treatment of unfavorable localized adenocarcinoma of the prostate. J. Clin. Oncol. 22 10 (2004) 1909-1915 May 15
20. Brunsvig P.F., Hatlevoll R., Berg R., Lauvvang G., Owre K., Wang M., et al. Weekly docetaxel with concurrent radiotherapy in locally advanced non-small cell lung cancer: a phase I/II study with 5 years' follow-up. Lung Cancer 50 1 (2005) 97-105 Oct
21. Tishler R.B., Norris Jr. C.M., Colevas A.D., Lamb C.C., Karp D., Busse P.M., et al. A phase I/II trial of concurrent docetaxel and radiation after induction chemotherapy in patients with poor prognosis squamous cell carcinoma of the head and neck. Cancer 95 7 (2002) 1472-1481 Oct 1
22. Tishler R.B., Posner M.R., Norris Jr. C.M., Mahadevan A., Sullivan C., Goguen L., et al. Concurrent weekly docetaxel and concomitant boost radiation therapy in the treatment of locally advanced squamous cell cancer of the head and neck. Int. J. Radiat. Oncol. Biol. Phys. 65 4 (2006) 1036-1044 Jul 15
23. Calais G., Bardet E., Sire C., Alfonsi M., Bourhis J., Rhein B., et al. Radiotherapy with concomitant weekly docetaxel for stages III/IV oropharynx carcinoma. Results of the 98-02 GORTEC Phase II trial. Int. J. Radiat. Oncol. Biol. Phys. 58 1 (2004) 161-166 Jan 1
24. Fujii M., Tsukuda M., Satake B., Kubota A., Kida A., Kohno N., et al. Japan Cooperative Head and Neck Oncology Group (JCHNOG). Phase I/II trial of weekly docetaxel and concomitant radiotherapy for squamous cell carcinoma of the head and neck. Int. J. Clin. Oncol. 9 2 (2004) 107-112 Apr
25. Kodaira T., Fuwa N., Furutani K., Tachibana H., and Yamazaki T. Phase I trial of weekly docetaxel and concurrent radiotherapy for head and neck cancer in elderly patients or patients with complications. Jpn. J. Clin. Oncol. 35 4 (2005) 173-176 Apr
26. http://ctep.cancer.gov/forms/CTCAEv3.pdf (current guidelines)
27. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., 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. J. Natl. Cancer Inst. 92 3 (2000) 205-216 Feb 2
28. Cantor A.B. Projecting the standard error of the Kaplan-Meier estimator. Stat. Med. 20 (2001) 2091-2097
29. Merad M., Le Cesne A., Baldeyrou P., Mesurolle B., and Le Chevalier T. Docetaxel and interstitial pulmonary injury. Ann. Oncol. 8 2 (1997) 191-194 Feb
30. Read W.L., Mortimer J.E., and Picus J. Severe interstitial pneumonitis associated with docetaxel administration. Cancer 94 3 (2002) 847-853 Feb 1
31. Karacan O., Eyuboglu F.O., Akcay S., and Ozyilkan O. Acute interstitial pneumopathy associated with docetaxel hypersensitivity. Onkologie 27 6 (2004) 563-565 Dec
32. Wang G.S., Yang K.Y., and Perng R.P. Life-threatening hypersensitivity pneumonitis induced by docetaxel (Taxotere). Br. J. Cancer 85 9 (2001) 1247-1250 Nov 2
33. Leimgruber K., Negro R., Baier S., Moser B., Resch G., Sansone S., et al. Fatal interstitial pneumonitis associated with docetaxel administration in a patient with hormone-refractory prostate cancer. Tumori 92 6 (2006) 542-544 Nov-Dec
34. Chen Y.M., Shih J.F., Perng R.P., Tsai C.M., and Whang-Peng J. A randomized trial of different docetaxel schedules in non-small cell lung cancer patients who failed previous platinum-based chemotherapy. Chest 129 4 (2006) 1031-1038 Apr
35. Kelly K., Gaspar L.E., Chansky K., Albain K.S., Crowley J., Gandara D.R., and Southwest Oncology Group. Low incidence of pneumonitis on SWOG 0023: a preliminary analysis of an ongoing phase III trial of concurrent chemoradiotherapy followed by consolidation docetaxel and Iressa/placebo maintenance in patients with inoperable stage III non-small cell lung cancer. J. Clin. Oncol. 23 16s Pt 1 (2005) (abst 7058)
36. Maier U., Ehrenböck P.M., and Hofbauer J. Late urological complications and malignancies after curative radiotherapy for gynecological carcinomas: a retrospective analysis of 10,709 patients. J. Urol. 158 3 Pt 1 (1997) 814-817 Sep
37. Eifel P.J., Levenback C., Wharton J.T., and Oswald M.J. Time course and incidence of late complications in patients treated with radiation therapy for FIGO stage IB carcinoma of the uterine cervix. Int. J. Radiat. Oncol. Biol. Phys. 32 5 (1995) 1289-1300 Jul 30
38. Whitney C.W., Sause W., Bundy B.N., Malfetano J.H., Hannigan E.V., Fowler Jr. W.C., et al. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J. Clin. Oncol. 17 5 (1999) 1339-1348 May
39. Rose P.G., Bundy B.N., Watkins E.B., Thigpen J.T., Deppe G., Maiman M.A., et al. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N. Engl. J. Med. 340 15 (1999 Apr 15) 1144-1153 Erratum in: N Engl J Med 1999 Aug 26;341(9):708
40. Pillay C.V., Green-Thompson R., and Brock-Utne J.G. Efficacy of the anticancer agent cisplatin in the treatment of human cervical squamous carcinoma xenografted in nude mice. Chemotherapy 32 4 (1986) 356-363
41. Moore D.H., Blessing J.A., McQuellon R.P., Thaler H.T., Cella D., Benda J., et al. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J. Clin. Oncol. 22 15 (2004) 3113-3119 Aug 1
42. Britten R.A., Evans A.J., Allalunis-Turner M.J., and Pearcey R.G. Effect of cisplatin on the clinically relevant radiosensitivity of human cervical carcinoma cell lines. Int. J. Radiat. Oncol. Biol. Phys. 34 2 (1996) 367-374 Jan 15
43. Gallo D., Ferlini C., Distefano M., Cantelmo F., Gaggini C., Fattorossi A., et al. Anti-tumour activity of a panel of taxanes toward a cellular model of human cervical cancer. Cancer Chemother. Pharmacol. 45 2 (2000) 127-132
44. Araki S., Miyagi Y., Kawanishi K., Yamamoto J., Hongo A., Kodama J., et al. Neoadjuvant treatment with docetaxel and the effects of irradiation for human ovarian adenocarcinoma and cervical squamous cell carcinoma in vitro. Acta Med. Okayama 56 1 (2002) 13-18 Feb
45. Vallejo C.T., Machiavelli M.R., Perez J.E., Romero A.O., Bologna F., Vicente H., et al. Docetaxel as neoadjuvant chemotherapy in patients with advanced cervical carcinoma. Am. J. Clin. Oncol. 26 5 (2003) 477-482 Oct
46. Giardina G., Richiardi G., Danese S., Ottone P., Ohlmeier U., and Gargiulo T. Weekly cisplatin as neoadjuvant chemotherapy in locally advanced cervical cancer: a well-tolerated alternative. Eur. J. Gynaecol. Oncol. 18 3 (1997) 173-176
47. Allal A.S., Zwahlen D., Becker M., Dulguerov P., and Mach N. Phase I trial of concomitant hyperfractionated radiotherapy with docetaxel and cisplatin for locally advanced head and neck cancer. Cancer J. 12 1 (2006) 63-68 Jan-Feb