A phase I-II study of weekly cisplatin and gemcitabine with concurrent radiotherapy in locally advanced cervical carcinoma

Annals of Oncology

Volumn 14, Issue 8, 2003, Pages 1285-1290

  Zarba J J ^a   Jaremtchuk, A V ^a   Gonzalez Jazey, P ^a   Keropian, M ^a   Castagnino, R ^a   Mina, C ^a   Arroyo, G ^a  

^a GETICS   (Argentina)

Author keywords

Cervical cancer; Cisplatin; Concurrent chemoradiotherapy; Gemcitabine

Indexed keywords

CISPLATIN; GEMCITABINE;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASTHENIA; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER RECURRENCE; CANCER REGRESSION; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOSE RESPONSE; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HISTOPATHOLOGY; HUMAN; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; NAUSEA AND VOMITING; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SKIN TOXICITY; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT OUTCOME; UTERINE CERVIX CARCINOMA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SQUAMOUS CELL; CISPLATIN; COMBINED MODALITY THERAPY; CONFIDENCE INTERVALS; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; MIDDLE AGED; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PROBABILITY; RADIOTHERAPY, ADJUVANT; SURVIVAL ANALYSIS; TREATMENT OUTCOME; UTERINE CERVICAL NEOPLASMS;

EID: 0042510466     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdg345     Document Type: Article

References (43)

1. Petersson F (ed): Carcinoma of the cervix. In Annual Report on the Results of Treatments in Gynecological Cancer. Stockholm, Sweden: International Federation of Gynecology and Obstetrics 1988; 29-33.
2. Keys HM, Bundy BN, Stehman FB et al. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med 1999; 340: 1154-1161.
3. Rose PJ, Bundy BN, Watkins EB et al. Concurrent cisplatin based chemotherapy and radiotherapy for locally advanced cervical cancer. N Engl J Med 1999; 340: 1144-1153.
4. Morris M, Eifel PJ, Lu J et al. Pelvic radiation with concurrent chemotherapy compared with pelvic and para aortic radiation for high-risk cervical cancer. N Engl J Med 1999; 340: 1137-1143.
5. Whitney CW, Sause W, Bundy BN et al. A randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stages IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes. J Clin Oncol 1999; 17: 1339-1348.
6. Peters WA, Liu PY, Barret RJ et al. Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high risk early-stage cancer of the cervix. J Clin Oncol 2000; 18: 1606-1613.
7. National Cancer Institute. Clinical Announcement: Concurrent chemoradiation for cervical cancer. Washington, DC, 22 February 1999.
8. Goedhals L, Bezwoda WR. A phase II study of gemcitabine in advanced cervix carcinoma: final data. Proc Am Soc Clin Oncol 1996; 15: 296 (Abstr 819).
9. Schilder RJ, Blessing JA, Morgan M et al. Evaluation of gemcitabine in patients with squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol 2000; 76: 204-207.
10. Lawrence TS, Eisbruch A, Shewach DS. Gemcitabine-mediated radiosensitization. Semin Oncol 1997; 24 (Suppl 7): S7-24-S7-28.
11. Milas L, Fuji T, Hunter N et al. Enhancement of tumor radioresponse in vivo by gemcitabine. Cancer Res 1999; 59: 107-114.
12. Mohideen M, McCall A, Kamradt R. Activity of gemcitabine and its radiosensitization of human cervical cancer cells. Proc Am Soc Clin Oncol 1997; 17: 245 (Abstr 865).
13. McCormack M, Thomas H. A phase Ib study of gemcitabine and concurrent radiotherapy in carcinoma of the cervix. Ann Oncol 2000; 11 (Suppl 4): 396P.
14. Pattaranutaporn P, Thirapakawong C, Chansilpa Y et al. Study of concurrent gemcitabine and radiotherapy in locally advanced stage IIIB cervical carcinoma. Proc Am Soc Clin Oncol 2000; 19: 390 (Abstr 1545).
15. Kanzawa F, Saijo N. In vitro interaction between gemcitabine and other anticancer drugs using a novel three-dimensional model. Semin Oncol 1997; 24 (Suppl 7): S7-8-S7-16.
16. Van Moorsel CJ, Veerman G, Bergman AM et al. Combination chemotherapy studies with gemcitabine. Semin Oncol 1997; 24 (Suppl 7): S7-17-S7-23.
17. Brunner T, Grabenbauer G, Kastl S et al. A phase I trial of simultaneous gemcitabine (GEM)/cisplatin (CDDP) and radiotherapy (RT) for patients (PTS) with locally advanced pancreatic adenocarcinoma (PAC). Proc Am Soc Clin Oncol 2000; 19: 284 (Abstr 1109).
18. Varveris C, Lyraraki E, Kachris S et al. Phase I/II study of gemcitabine combined with cisplatin weekly and concurrent thoracic MV-radiotherapy for patients with stage IIIA/B non small lung cancer (NSCLC). Proc Am Soc Clin Oncol 2000; 19: 537 (Abstr 2116).
19. Gross G, Lochrin C, Perry G et al. A phase I study of gemcitabine and cisplatin with concurrent curative irradiation in stage III non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 1999; 18: 515 (Abstr 1986).
20. Lawrence TS, Eisbruch A, Shewach DS. Gemcitabine-mediated radiosensitization. Semin Oncol 1997; 24 (Suppl 7): S7-24-S7-28.
21. Lawrence TS, Chang EY, Hahn TM et al. Radiosensitization of pancreatic cancer cell by 2′,2′-difluoro-2′-deoxycytidine. Int J Radiat Oncol Biol Phys 1996; 34: 867-872.
22. Rosier J-F, Beauduin M, Bruniaux M et al. The effect of 2′ -2′ difluorode-oxycytidine (dFdC, gemcitabine) on radiation-induced cell lethality in two human head and neck squamous carcinoma cell lines differing in intrinsic radiosensitivity. Int J Radiat Oncol Biol Phys 1999; 75: 245-251.
23. Mose KA, Karepetian M, Juling-Pohlit L et al. Radiation enhancement of gemcitabine in two human squamous cell carcinoma cell lines. Anticancer Res 2000; 20: 401-405.
24. Mason KA, Milas L, Hunter NR et al. Maximizing therapeutic gain with gemcitabine and fractionated radiation. Int J Radiat Oncol Biol Phys 1999; 44: 1125-1135.
25. Gregorie V, Hittelman WN, Rosier J-F et al. Chemo-radiotherapy: radiosensitizing nucleoside analogues. Oncol Rep 1999; 6: 949-957.
26. McGinn CJ, Smith DC, Szarka CE et al. A phase I study of gemcitabine (GEM) in combination with radiation therapy (RT) in patients with localized, unresectable pancreatic cancer. Proc Am Soc Clin Oncol 1998; 17: 264 (Abstr 1014).
27. Reyes-Vidal J, Rodriguez P, Reyes J et al. Chemoradiation therapy with gemcitabine (GEM) in advanced pancreatic cancer (APC). Proc Am Soc Clin Oncol 2000; 19: 301 (Abstr 1183).
28. Maurer U, Stegmeier P, Botle R et al. Gemcitabine (G) in combination with radiotherapy (RT) in stage III-IV pancreatic cancer: first results of a current phase I study. Eur J Cancer 1999; 35 (Suppl 4): S148 (Abstr 544).
29. Herscher LL, Muir CM, Kroog CS et al. A phase I trial of gemcitabine and radiation in locally advanced unresectable cancer of the pancreas. Proc Am Assoc Cancer Res 2000; 41: (Abstr 613).
30. Epelbaum R, Rosenblatt E, Nasrallah S et al. A phase II study of gemcitabine (GEM) combined with radiation therapy (RT) in patients with localized unresectable pancreatic cancer. Proc Am Soc Clin Oncol 2000; 19: 265 (Abstr 1029).
31. Antonisse IE, van Groeningen CJ, Langendijk JA et al. A phase II study of hypofractionated radiotherapy in combination with gemcitabine in the palliative treatment of advanced pancreatic carcinoma. Eur J Cancer 1999; 35 (Suppl 4): 514.
32. Abad A, Arellano A, Brunet J et al. Gemcitabine plus radiotherapy in stage II-III pancreatic cancer: a phase I trial. Ann Oncol 1998; 9 (Suppl 4): 253.
33. Blackstock AW, Bernard S, Poole M et al. Concurrent radiation and twice weekly gemcitabine for unresectable pancreatic cancer. Cancer Invest 2000; 18 (Suppl 1): 24-26.
34. Wong S, Oza A, Brierly J et al. Phase I study of gemcitabine (G) and escalation dose radiation therapy (RT) in patients with pancreatic carcinoma. Proc Am Soc Clin Oncol 2000; 19: 268 (Abstr 1041).
35. Goor C, Scalliet P, Van Meerbeek J et al. A phase II study of combining gemcitabine and radiotherapy in stage III NSCLC. Ann Oncol 1996; 7: 110 (Abstr 481).
36. Scalliet P, Goor C, Galdermans D et al. Gemzar (gemcitabine) with thoracic radiotherapy - a phase II pilot study in chemonaive patients with advanced non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 1998; 17: 499 (Abstr 1923).
37. Groen H, Gregor A, Van Putten J et al. Phase I study of gemcitabine (G) and high-dose thoracic radiation (RT) in stage III non-small cell lung cancer. Proc Am Soc Clin Oncol 2000; 19: 539 (Abstr 2123).
38. Gonzalez E, Sanchez-Rovira P, Jaen A et al. Phase I study concomitant gemcitabine (G) with radiotherapy (RT) in stage III NSCLC. Eur J Cancer 1999; 35 (Suppl 4): S265 (Abstr 1054).
39. Eisbruch A, Shewach DS, Bradford CR et al. Radiation (RT) concurrent with low dose gemcitabine (GEM) for head and neck cancer: interim results of a phase I study. Proc Am Soc Clin Oncol 1998; 17: 405 (Abstr 1563).
40. Jaremtchuk AV, Zarba JJ, Keropian M et al. Phase I study of gemcitabine combined with radiotherapy with or without amifostine in patients with locally advanced head and neck cancer. Proc Am Soc Clin Oncol 2000; 19: 424 (Abstr 1674).
41. Wildfang I, Raub M, Guner SA et al. Low-dose gemcitabine with radiotherapy in advanced head and neck and thyroid cancer, a new radiosensitizing approach. J Cancer Res Clin Oncol 2000; 126 (Suppl): (Abstr 40).
42. Malfetano JH, Keys H, Cunningham MJ et al. Extended field radiation and cisplatin for stage IIB and IIIB cervical carcinoma. Gynecol Oncol 1997; 67: 203-207.
43. Fields AL, Anderson PS, Golbert GL et al. Mature results of a phase II trial of concomitant cisplatin/pelvic radiotherapy for locally advanced squamous cell carcinoma of the cervix. Gynecol Oncol 1996; 61: 416-420.