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Gemcitabine, Capecitabine, and Oxaliplatin as Second-Line Therapy in Treating Patients With Advanced Colorectal Cancer Previously Treated With Irinotecan

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 3, 2007
Last updated: August 20, 2009
Last verified: August 2009

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, capecitabine, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gemcitabine when given together with capecitabine and oxaliplatin as second-line therapy and to see how well it works in treating patients with advanced colorectal cancer previously treated with irinotecan.

Condition Intervention Phase
Colorectal Cancer
Drug: capecitabine
Drug: gemcitabine hydrochloride
Drug: oxaliplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study to Determine the Safety and Efficacy of Second-Line Treatment With XELOX Plus Gemcitabine in Irinotecan Pre-Treated Advanced Colorectal Cancer Patients

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall response rate as assessed by RECIST criteria

Secondary Outcome Measures:
  • Progression-free survival
  • Duration of response
  • Time to treatment failure
  • Overall survival
  • Time to response

Estimated Enrollment: 56
Study Start Date: January 2007
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:



  • Define the dose-limiting toxicity and maximum tolerated dose of gemcitabine hydrochloride when administered with capecitabine and oxaliplatin as second-line therapy in patients with advanced colorectal cancer previously treated with irinotecan hydrochloride. (Phase I)
  • Determine the recommended phase II dose of gemcitabine hydrochloride in these patients. (Phase I)
  • Assess overall response rate in patients treated with this regimen. (Phase II)


  • Assess the progression-free survival of patients treated with this regimen. (Phase II)
  • Assess the time to treatment failure, duration of response, and time to response in patients treated with this regimen. (Phase II)
  • Assess the overall survival of patients treated with this regimen. (Phase II)
  • Assess the safety of this regimen in these patients. (Phase II)

OUTLINE: This is a multicenter, phase I, dose-escalation study of gemcitabine hydrochloride, followed by a phase II, open-label study.

  • Phase I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, oral capecitabine twice daily on days 1-14, and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the maximum tolerated dose (MTD) is determined.

  • Phase II: Patients receive gemcitabine hydrochloride at the MTD determined in phase I and capecitabine and oxaliplatin as in phase I.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed advanced colorectal adenocarcinoma
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Must have received prior irinotecan hydrochloride with a progression-free interval of < 3 months
  • No symptomatic brain metastases


  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST and ALT ≤ 3 times ULN (5 times ULN if liver metastases are present)
  • Creatinine ≤ 1.5 times ULN
  • No significant cardiac abnormalities by ECG
  • No known hypersensitivity to the study drugs or any of their components
  • No myocardial infarction within the past 12 months
  • No uncontrolled congestive heart failure
  • No cardiovascular disorder ≥ grade 3 despite treatment
  • No other malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
  • No significant disease, that in the opinion of the investigator, would preclude study treatment (e.g., active infections, interstitial lung disease, or peripheral neuropathy)
  • No history of significant neurological or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder)
  • No legal incapacity or limited legal capacity that would preclude study participation


  • See Disease Characteristics
  • Recovered from all prior therapy
  • More than 30 days since prior participation in another clinical trial
  • No concurrent warfarin, phenprocoumon, phenytoin, or sorivudine
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Please refer to this study by its identifier: NCT00496704

Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Joong B. Ahn, MD    82-2-2228-8134      
Sponsors and Collaborators
Yonsei University
Principal Investigator: Joong B. Ahn, MD Yonsei University
  More Information Identifier: NCT00496704     History of Changes
Other Study ID Numbers: CDR0000549901
Study First Received: July 3, 2007
Last Updated: August 20, 2009

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the colon
recurrent colon cancer
stage III colon cancer
stage IV colon cancer
adenocarcinoma of the rectum
recurrent rectal cancer
stage III rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on April 21, 2017