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Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00677144
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : October 5, 2012
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Hallym University Medical Center

Brief Summary:
The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (OS) and Oxaliplatin and Capecitabine (XELOX) in patients with advance or recurrent colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasm Drug: OS (oxalipaltin+S-1) Drug: XELOX (oxalipaltin+capecitabine) Phase 2

Detailed Description:
Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for colorectal cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with S-1 (OS) and several phase II trial of combination chemotherapy of oxaliplatin with capecitabine (XELOX) demonstrated good activity and mild toxicity in advanced colorectal cancer. Oxaliplatin and S-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities. Furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in preclinical models but also in subsequent clinical trials.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Advanced or Recurrent Colorectal Cancer
Study Start Date : April 2008
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: OS (oxalipaltin+S-1)
OS (oxaliplatin + S-1): Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days
Drug: OS (oxalipaltin+S-1)
Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days
Other Names:
  • Eloxatin
  • TS-1
Active Comparator: XELOX (oxalipaltin+capecitabine)
XELOX (oxalipaltin+capecitabine): Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Drug: XELOX (oxalipaltin+capecitabine)
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Other Names:
  • Eloxatin
  • Xeloda



Primary Outcome Measures :
  1. overall response rate [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Safety, time to progression, and overall survival [ Time Frame: 4.6 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
  • Unresectable, locally advanced or metastatic
  • At least one uni-dimensional measurable lesion by RECIST criteria
  • Age 18 to 75 years old
  • Estimated life expectancy ≥3 months
  • ECOG performance status ≤2
  • Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL)
  • Adequate kidney function (creatinine < 1.5 mg/dL)
  • Adequate liver function (bilirubin < 2.0 mg/dL, transaminase levels <2.5 times the upper normal limit)
  • Written informed consent

Exclusion Criteria:

  • Other tumor type than adenocarcinoma
  • Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
  • Presence of CNS metastasis, psychosis, or seizure
  • Obvious bowel obstruction
  • Evidence of serious gastrointestinal bleeding
  • Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • Other serious illness or medical conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677144


Locations
Korea, Republic of
Hallym University Medical Center
Anyang, Korea, Republic of, 431-070
Sponsors and Collaborators
Hallym University Medical Center
Sanofi
Investigators
Principal Investigator: Dae Young Zang, MD, PhD Hallym University Medical Center

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT00677144     History of Changes
Other Study ID Numbers: HMC-HO-GI-0712
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: October 5, 2012
Last Verified: October 2012

Keywords provided by Hallym University Medical Center:
Colorectal Neoplasm
S-1
Capecitabine
Oxaliplatin

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents