Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 1/2012

01-01-2012 | Original Article

Combining capecitabine, oxaliplatin, and gemcitabine (XELOXGEM) for colorectal carcinoma patients pretreated with irinotecan: a multicenter phase I/II trial

Authors: Se Hyun Kim, Sang Joon Shin, Sun Young Kim, Se Hoon Lee, Young Suk Park, Se Hoon Park, Kyung Hee Lee, Tae Won Kim, Yong Sang Hong, Joong Bae Ahn

Published in: Cancer Chemotherapy and Pharmacology | Issue 1/2012

Login to get access

Abstract

Purpose

Capecitabine plus oxaliplatin (XELOX) is an effective second-line regimen for advanced colorectal carcinoma (CRC) patients pretreated with irinotecan. Previous studies have shown supra-additive anti-tumor activity of gemcitabine (GEM) when administered with oxaliplatin. We investigated the dose, toxicity, and efficacy of a second-line XELOXGEM regimen in CRC patients pretreated with irinotecan.

Methods

Patients with metastatic or recurrent CRC who failed after a first-line irinotecan-containing regimen received escalating doses of gemcitabine (600, 800, 1,000 mg/m2 d1, d8) followed by capecitabine (1,000 mg/m2 b.i.d d1–14) and oxaliplatin (100 mg/m2 d1) on a 21-day cycle.

Results

A total of 38 patients were treated. At 800 mg/m2, two of six patients experienced dose-limiting toxicities (diarrhea and thrombocytopenia). Therefore, the clinically recommended dose was defined as 600 mg/m2 gemcitabine (d1, d8) followed by 1,000 mg/m2 capecitabine (b.i.d dl–14) and 100 mg/m2 oxaliplatin (d1). The most common grade 3/4 toxicities were neutropenia (32%), thrombocytopenia (13%), anemia (11%), and peripheral neuropathy (11%). Ten (26.3%) and 23 (60.5%) patients experienced partial response and stable disease, respectively. The median progression-free survival and overall survival were 5.4 months (95% CI 3.8–6.9 months) and 17.7 months (95% CI 8.4–26.9 months), respectively.

Conclusions

The XELOXGEM triplet combination is an active and safe second-line regimen for advanced CRC patients pretreated with irinotecan.
Literature
1.
2.
Capdevila J, Ramos FJ, Macarulla T (2009) The role of salvage treatment in advanced colorectal cancer. Crit Rev Oncol Hematol 71:53–61PubMedCrossRef
3.
Pfeiffer P, Sørbye H, Ehrsson H et al (2006) Short-time infusion of oxaliplatin in combination with capecitabine (XELOX30) as second-line therapy in patients with advanced colorectal cancer after failure to irinotecan and 5-fluorouracil. Ann Oncol 17:252–258PubMedCrossRef
4.
Rothenberg ML, Cox JV, Butts C et al (2008) Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer: a randomized phase III noninferiority study. Ann Oncol 19:1720–1726PubMedCrossRef
5.
Koopman M, Antonini NF, Douma J et al (2007) Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomized controlled trial. Lancet 370:135–142PubMedCrossRef
6.
Moore DF Jr, Pazdur R, Daugherty K et al (1992) Phase II study of gemcitabine in advanced colorectal adenocarcinoma. Invest New Drugs 10(4):323–325PubMedCrossRef
7.
Faivre S, Raymond E, Woynarowski JM, Cvitkovic E (1999) Supraadditive effect of 2′,2′-difluorodeoxcycytidine (gemcitabine) in combination with oxaliplatin in human cancer cell lines. Cancer Chemother Pharmacol 44:117–123PubMedCrossRef
8.
Correale P, Messinese S, Caraglia M et al (2004) A novel biweekly multidrug regimen of gemcitabine, oxaliplatin, 5-fluorouracil (5-FU), and folinic acid (FA) in pretreated patients with advanced colorectal carcinoma. Br J Cancer 90:1710–1714PubMed
9.
Ziras N, Potamianou A, Varthalitis I et al (2006) Multicenter phase II study of gemcitabine and oxaliplatin (GEMOX) as second-line chemotherapy in colorectal cancer patients pretreated with 5-Fluorouracil plus irinotecan. Oncology 70(2):106–114PubMedCrossRef
10.
Tan BR, Brenner WS, Picus J et al (2008) Phase I study of biweekly oxaliplatin, gemcitabine and capecitabine in patients with advanced upper gastrointestinal malignancies. Ann Oncol 19:1742–1748PubMedCrossRef
11.
Hess V, Pratsch S, Potthast S et al. (2010) Combining gemcitabine,oxaliplatin and capecitabine (GEMOXEL) for patients with advanced pancreatic carcinoma (APC): a phase I/II trial. Ann oncol 2010 Published on May 5 doi:10.​1093/​annonc/​mdq242
12.
Cassidy J, Clarke S, Diaz-Rubio E et al (2008) Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol 26:2006–2012PubMedCrossRef
13.
Schmoll HJ, Cartwright T, Tabernero J et al (2007) Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1, 864 patients. J Clin Oncol 25:102–109PubMedCrossRef
14.
Scappaticci FA, Skillings JR, Holden SN et al (2007) Arterial thromboembolic events in patients with metastatic carcinoma treated with chemotherapy and bevacizumab. J Natl Cancer Inst 99:1232–1239PubMedCrossRef
15.
August DA, Serrano D, Poplin E (2008) “Spontaneous”, delayed colon and rectal anastomotic complications associated with bevacizumab therapy. J Surg Oncol 97:180–185PubMedCrossRef
16.
Bajetta E, Celio L, Ferrario E et al (2007) Capecitabine plus oxaliplatin and irinotecan regimen every other week: a phase I/II study in first-line treatment of metastatic colorectal cancer. Ann Oncol 18:1810–1816PubMedCrossRef
17.
Falcone A, Ricci S, Brunetti I et al. (2007) Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol 25:1670–1676
Metadata
Title
Combining capecitabine, oxaliplatin, and gemcitabine (XELOXGEM) for colorectal carcinoma patients pretreated with irinotecan: a multicenter phase I/II trial
Authors
Se Hyun Kim
Sang Joon Shin
Sun Young Kim
Se Hoon Lee
Young Suk Park
Se Hoon Park
Kyung Hee Lee
Tae Won Kim
Yong Sang Hong
Joong Bae Ahn
Publication date
01-01-2012
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 1/2012
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-011-1668-y

Other articles of this Issue 1/2012

Cancer Chemotherapy and Pharmacology 1/2012 Go to the issue

Original Article

Dose-escalation and pharmacokinetic study of nanoparticle curcumin, a potential anticancer agent with improved bioavailability, in healthy human volunteers

Original Article

Triptolide augments the effects of 5-lipoxygenase RNA interference in suppressing pancreatic tumor growth in a xenograft mouse model

Original Article

5, 7-Dimethoxyflavone sensitizes TRAIL-induced apoptosis through DR5 upregulation in hepatocellular carcinoma cells

Short Communication

Pharmacokinetic drug interaction between AEE788 and RAD001 causing thrombocytopenia in patients with glioblastoma

Original Article

A phase I trial of oral metronomic vinorelbine plus capecitabine in patients with metastatic breast cancer

Original Article

Gene polymorphisms, pharmacokinetics, and hematological toxicity in advanced non-small-cell lung cancer patients receiving cisplatin/gemcitabine
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Watch now

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine
Image Credits