Journal of Clinical Oncology, Vol 15, 625-631, Copyright © 1997 by American Society of Clinical Oncology
Phase II study of irinotecan in prior chemotherapy-treated squamous cell carcinoma of the cervix
CF Verschraegen, T Levy, AP Kudelka, E Llerena, K Ende, RS Freedman, CL Edwards, M Hord, M Steger, AL Kaplan, D Kieback, A Fishman and JJ Kavanagh
University of Texas M.D. Anderson Cancer Center, Houston 77030, USA. cverschr@notes.mdacc.tmc.edu
PURPOSE: A phase II study was performed to evaluate the antitumor activity
and toxicity of irinotecan (CPT-11), a water-soluble derivative of
camptothecin, in patients with prior chemotherapy-treated squamous cell
cancer of the cervix. PATIENTS AND METHODS: Forty-two patients were
included in the study. The median age was 44 years (range, 24 to 59 years).
The median Zubrod performance status was 1. All patients were refractory to
first-line chemotherapy and 88% had received prior radiotherapy. The
initial dose of CPT-11 was 125 mg/m2 given as a weekly 90-minute
intravenous infusion for 4 weeks, every 6 weeks. Subsequent doses were
unchanged, reduced, or omitted according to toxicity grade. RESULTS:
Forty-two patients were assessable for response. The overall response rate
was 21%. The median time to response was 6 weeks and the median duration of
response was 12 weeks. The overall median duration of survival was 6.4
months. A statistically significant survival advantage (median of 12.6 v
5.1 months) was found in patients whose disease responded to the treatment
(P < .015). The major dose-limiting toxic effects (grade > or = 3)
were nausea and vomiting (45%), diarrhea (24%), and granulocytopenia (36%).
Grade > or = 3 anemia was encountered in 62% of patients and the
incidence of thrombocytopenia was negligible. Less severe side effects were
alopecia (48%), drug fever (43%), anorexia (33%), fatigue (33%), skin rash
(21%), stomatitis (14%), and allergic reaction (9%). The gastrointestinal
intolerance was dose-related. The incidence of bone marrow depression did
not decrease with dose reduction, possibly because of a cumulative effect
or hematologic intolerance by a subset of patients. CONCLUSIONS: CPT-11 has
significant activity in refractory cervical carcinoma. Gastrointestinal
intolerance and hematologic toxicity must be monitored carefully. Further
studies of alternative schedules may improve the tolerance and response
rate.
This article has been cited by other articles:
|
|
|
|
 
H. J. Long III
Management of Metastatic Cervical Cancer: Review of the Literature
J. Clin. Oncol.,
July 10, 2007;
25(20):
2966 - 2974.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
L. J. Schaaf, L. A. Hammond, S. J. Tipping, R. M. Goldberg, R. Goel, J. G. Kuhn, L. L. Miller, L. D. Compton, L. A. Cisar, G. L. Elfring, et al.
Phase 1 and pharmacokinetic study of intravenous irinotecan in refractory solid tumor patients with hepatic dysfunction.
Clin. Cancer Res.,
June 15, 2006;
12(12):
3782 - 3791.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. V. Fiorica
Update on the Treatment of Cervical and Uterine Carcinoma: Focus on Topotecan
Oncologist,
October 1, 2002;
7(90005):
36 - 45.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. Ikegami, L. Ha, K. Arimori, P. Latham, K. Kobayashi, S. Ceryak, Y. Matsuzaki, and B. Bouscarel
Intestinal Alkalization As a Possible Preventive Mechanism in Irinotecan (CPT-11)-induced Diarrhea
Cancer Res.,
January 1, 2002;
62(1):
179 - 187.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. P. Stevenson, M. Redlinger, L. A.J. Kluijtmans, W. Sun, K. Algazy, B. Giantonio, D. G. Haller, C. Hardy, A. S. Whitehead, and P. J. O'Dwyer
Phase I Clinical and Pharmacogenetic Trial of Irinotecan and Raltitrexed Administered Every 21 Days to Patients With Cancer
J. Clin. Oncol.,
October 15, 2001;
19(20):
4081 - 4087.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
Y. Shigeoka, K. Itoh, T. Igarashi, K. Ishizawa, T. Saeki, H. Fujii, H. Minami, S. Imoto, and Y. Sasaki
Clinical Effect of Irinotecan in Advanced and Metastatic Breast Cancer Patients Previously Treated with Doxorubicin- and Docetaxel-containing Regimens
Jpn. J. Clin. Oncol.,
August 1, 2001;
31(8):
370 - 374.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. L. Rothenberg
Irinotecan (CPT-11): Recent Developments and Future Directions-Colorectal Cancer and Beyond
Oncologist,
February 1, 2001;
6(1):
66 - 80.
[Abstract]
[Full Text]
|
|
|
|
|
|
|
C. Lhomme, P. Fumoleau, P. Fargeot, Y. Krakowski, V. Dieras, J. Chauvergne, P. Vennin, P. Rebattu, H. Roche, J.-L. Misset, et al.
Results of a European Organization for Research and Treatment of Cancer/Early Clinical Studies Group Phase II Trial of First-Line Irinotecan in Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Cervix
J. Clin. Oncol.,
October 1, 1999;
17(10):
3136 - 3142.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. F. DeVore, D. H. Johnson, J. Crawford, J. Garst, I. W. Dimery, J. Eckardt, S. G. Eckhardt, G. L. Elfring, L. J. Schaaf, C. K. Hanover, et al.
Phase II Study of Irinotecan Plus Cisplatin in Patients With Advanced Non-Small-Cell Lung Cancer
J. Clin. Oncol.,
September 1, 1999;
17(9):
2710 - 2710.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. A. Papadimitriou, K. Sarris, L. A. Moulopoulos, G. Fountzilas, A. Anagnostopoulos, Z. Voulgaris, D. Gika, N. Giannakoulis, E. Diakomanolis, and M. A. Dimopoulos
Phase II Trial of Paclitaxel and Cisplatin in Metastatic and Recurrent Carcinoma of the Uterine Cervix
J. Clin. Oncol.,
March 1, 1999;
17(3):
761 - 761.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. A. Skirvin and V. Relias
Review : Topoisomerase I inhibitors: 2. Irinotecan
Journal of Oncology Pharmacy Practice,
June 1, 1998;
4(2):
103 - 116.
[Abstract]
[PDF]
|
|
|
|
