S-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer

A Randomized Phase II Study of Comparing S-1/Leucovorin With sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer

This phase II trial on the assumption that S-1 combined with Leucovorin may have better efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with advanced colorectal cancer.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: S-1, Leucovorin; Drug: leucovorin, 5-fluorouracil

Detailed Description

This is a randomized phase Ⅱ study, in which S-1 is used in combination with leucovorin in elderly patients with advanced colorectal cancer as first-line treatment,comparing with sLV5FU2 therapy. The aim of this study is to determine the efficacy and safety of S-1/LV in elderly patients in the first-line setting. The other secondary endpoints are progression free survival,overall survival, and quality of life are also evaluated.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jin Li, MD,PhD; Phone Number: 5100 64175590
• Study Contact Backup: Name: Wenhua Li, MS; Phone Number: 8900 64175590; Email: whliiris@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Jin Li'
      • Contact: Jin Li, MD,PhD; Phone Number: 5100 8621 64175590
      • Contact: Wenhua Li, MS; Phone Number: 8900 862164175590; Email: whliiris@hotmail.com
      • Sub-Investigator: Wen Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed written informed consent
• Oral medication is acceptable
• Histologically confirmed colorectal carcinoma
• Male or female ≥ 65 years of age
• No prior chemotherapy,radiotherapy,target therapy and immunotherapy, except adjuvant chemotherapy with an interval of ≥ 180 days)
• Presence of at least one target lesion measurable by CT scan or MRI,within 15 days prior to trial
• The lab values within 2 weeks prior to trial should meet:

PLT ≥7.5*10^4/mm3 ANC≥2000/mm3 HB≥100g/L Total bilirubin < upper limit of normal level ALT/AST/ALP < 2.5 x UNL (<5 x UNL for patients with liver or bone metastasis) Serum creatinine < UNL

• Performance status (ECOG) 0~1
• Life expectation longer than 90 days

Exclusion Criteria:

• Allergy to S-1,fluorouracil or leucovorin
• Any investigational agent(s) within 4 weeks prior to entry
• Previous or currently exposure to certain drugs which are proved to have influence on blood drug concentration
• Active infection
• Severe organ failures or diseases, including: intestinal obstruction, pulmonary fibrosis, uncontrolled diabetes mellitus,clinically relevant coronary disease, cardiovascular disorder or myocardial infarction,renal or liver failure, severe psychiatric illness,cerebral vascular disease and sever GI ulcer which need blood infusion.
• Uncontrolled hydrothorax,ascites and hydropericardium
• Multiple bone metastatic lesions
• Brain metastases
• Chronic diarrhea or digestive disfunction
• Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
• Strong willingness to receive surgery or highly potential to have intestinal obstruction which may need surgery intervention
• Other conditions that primary investigate or investigator consider to be unsuitable for the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S-1/LV; S-1 combined with Leucovorin	Drug: S-1, Leucovorin; S-1 : The initial dosage of S-1 is determined by the body surface area: Surface area: 1.25-1.5 m2 : 50mg twice per day;upper than 1.5 m2 : 60mg twice per day Leucovorin: 25mg twice per day po. The treatment is given for one week,and no chemotherapy is given for the following one week.; Other Names: chemotherapy
Active Comparator: sLV5FU2; 5-FU/LV infusion	Drug: leucovorin, 5-fluorouracil; leucovorin: 400mg/m2 intravenous infusion d1; 5-fluorouracil: 400mg/m2 intravenous push,d1; 2400mg/m2 continuous intravenous infusion for 46 hours repeat every 2 weeks; Other Names: chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
response rate	six weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
progression free survival	six weeks
disease control rate	six weeks
time to treatment failure	six weeks
overall survival	three months
quality of life	six weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	six weeks

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Jin Li, MD,PhD, Fudan University

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: August 31, 2010
• First Submitted That Met QC Criteria: September 1, 2010
• First Posted (Estimate): September 2, 2010

Study Record Updates

• Last Update Posted (Estimate): September 2, 2010
• Last Update Submitted That Met QC Criteria: September 1, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: chemotherapy; S-1; leucovorin; advanced colorectal cancer; 5-fluorouracil; elderly patients
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Leucovorin; Levoleucovorin
• Other Study ID Numbers: SL-eCRC