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

Colorectal Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677144
• Other study ID #: HMC-HO-GI-0712
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2008
• Last updated: October 4, 2012
• Start date: April 2008
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: Hallym University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang

Sponsors (2)

Lead Sponsor	Collaborator
Hallym University Medical Center	Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		4 years	No
Secondary	Safety, time to progression, and overall survival		4.6 years	Yes