Journal of Clinical Oncology, Vol 20, Issue 2
(January), 2002: 582-587
© 2002 American Society for Clinical Oncology
Dose-Escalating Study of Capecitabine Plus Gemcitabine Combination Therapy in Patients With Advanced Cancer
By Richard L. Schilsky,
Donna Bertucci,
Nicholas J. Vogelzang,
Hedy L. Kindler,
Mark J. Ratain
From the Department of Medicine, Section of Hematology-Oncology, Cancer Research Center and Committee on Clinical Pharmacology, University of Chicago, Chicago, IL.
Address reprint requests to Richard L. Schilsky, MD, Biological Sciences Division, MC 1000, University of Chicago, 5841 S Maryland Ave, Chicago, IL 60637; email: rschilsk{at}medicine.bsd.uchicago.edu
PURPOSE: The goals of this phase I study were to determine the maximum-tolerated doses of capecitabine and gemcitabine in patients with advanced cancer and to describe the dose-limiting toxicities (DLT) and safety profile of this combination.
PATIENTS AND METHODS: Eligible patients had advanced solid tumors that had failed to respond to standard therapy or for which no standard therapy was available, measurable or assessable disease, Karnofsky performance status  70%, and acceptable organ function. Capecitabine was administered twice daily by mouth each day for 21 consecutive days followed by a 1-week break. Gemcitabine was administered as a 30-minute intravenous infusion weekly for 3 weeks followed by a 1-week break.
RESULTS: Forty patients were enrolled onto the study, and 33 are fully assessable for toxicity. The most common toxicities during the first cycle of chemotherapy were neutropenia and mucositis. Only one patient treated at gemcitabine and capecitabine doses of 800 and 2000 mg/m2, respectively, met protocol-specified DLT criteria; however, at these doses 65% of successive cycles required dose reduction or delay for toxicity. No episodes of DLT were observed at gemcitabine and capecitabine doses of 1,000 and 1,660 mg/m2, respectively, and 70% of cycles of therapy were delivered without dose reduction or delay. Therefore, these doses are recommended for further study. Tumor responses were observed in patients with metastatic colorectal and pancreatic cancer.
CONCLUSION: Gemcitabine and capecitabine can be combined with acceptable toxicity at nearly full doses. Antitumor activity of the combination merits further investigation in phase II studies.
Presented at the Thirty-Seventh Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001.
 CiteULike  Complore  Connotea  Del.icio.us  Digg  Facebook  Reddit  Technorati  Twitter What's this?
This article has been cited by other articles:
|
|
|
|
 
D. Cunningham, I. Chau, D. D. Stocken, J. W. Valle, D. Smith, W. Steward, P. G. Harper, J. Dunn, C. Tudur-Smith, J. West, et al.
Phase III Randomized Comparison of Gemcitabine Versus Gemcitabine Plus Capecitabine in Patients With Advanced Pancreatic Cancer
J. Clin. Oncol.,
November 20, 2009;
27(33):
5513 - 5518.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. Palmieri, G. Merola, P. Federico, L. Petillo, M. Marino, M. Lalle, M. Milella, A. Ceribelli, L. Montella, C. Merola, et al.
Preliminary results of phase II study of capecitabine and gemcitabine (CAP-GEM) in patients with metastatic pretreated thymic epithelial tumors (TETs)
Ann. Onc.,
October 30, 2009;
(2009)
mdp483v1.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D. Koeberle, P. Saletti, M. Borner, D. Gerber, D. Dietrich, C. B. Caspar, W. Mingrone, K. Beretta, F. Strasser, T. Ruhstaller, et al.
Patient-Reported Outcomes of Patients With Advanced Biliary Tract Cancers Receiving Gemcitabine Plus Capecitabine: A Multicenter, Phase II Trial of the Swiss Group for Clinical Cancer Research
J. Clin. Oncol.,
August 1, 2008;
26(22):
3702 - 3708.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. Herrmann, G. Bodoky, T. Ruhstaller, B. Glimelius, E. Bajetta, J. Schuller, P. Saletti, J. Bauer, A. Figer, B. Pestalozzi, et al.
Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group
J. Clin. Oncol.,
June 1, 2007;
25(16):
2212 - 2217.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
D Santini, V Virzi, B Vincenzi, L Rocci, V Leoni, and G Tonini
A phase I trial of fixed dose rate gemcitabine plus capecitabine in metastatic cancer patients
Ann. Onc.,
March 1, 2007;
18(3):
576 - 580.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. Gelmon, A. Chan, and N. Harbeck
The Role of Capecitabine in First-Line Treatment for Patients with Metastatic Breast Cancer
Oncologist,
September 1, 2006;
11(suppl_1):
42 - 51.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. Kralidis, S. Aebi, H. Friess, M. W. Buchler, and M. M. Borner
Activity of raltitrexed and gemcitabine in advanced pancreatic cancer
Ann. Onc.,
April 1, 2003;
14(4):
574 - 579.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
W. Scheithauer, B. Schull, H. Ulrich-Pur, K. Schmid, M. Raderer, K. Haider, W. Kwasny, D. Depisch, B. Schneeweiss, F. Lang, et al.
Biweekly high-dose gemcitabine alone or in combination with capecitabine in patients with metastatic pancreatic adenocarcinoma: a randomized phase II trial
Ann. Onc.,
January 1, 2003;
14(1):
97 - 104.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
V. Hess, M. Salzberg, M. Borner, R. Morant, A. D. Roth, C. Ludwig, and R. Herrmann
Combining Capecitabine and Gemcitabine in Patients With Advanced Pancreatic Carcinoma: A Phase I/II Trial
J. Clin. Oncol.,
January 1, 2003;
21(1):
66 - 68.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Malet-Martino and R. Martino
Clinical Studies of Three Oral Prodrugs of 5-Fluorouracil (Capecitabine, UFT, S-1): A Review
Oncologist,
August 1, 2002;
7(4):
288 - 323.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
