Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China (SCI-101)

A Multicenter Feasibility Study With S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients With Untreated Metastatic Colorectal Cancer

S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: S-1, leucovorin, oxaliplatin

Detailed Description

• Endpoints:
• Primary endpoints: adverse drug reaction

• Secondary endpoints:

  • Overall Response Rate：ORR
  • Progress Free Survival: PFS
  • Time to Treatment Failure：TTF

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100036
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Advanced unresectable or recurrent colorectal cancer patients which meet the following criteria:

  • Willing to sign ICF
  • Could orally take investigational product
  • Pathology diagnosis is adenocarcinoma
  • Above 20 years
  • No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)
  • For recurrent cases, if the patient had received adjuvant chemotherapy that didn't include S-1 and L-OHP in 180 days ago, he/she could be enrolled in
  • With target lesions with diameter which is longer than 1cm in spiral CT or MRI examination within 30 days

• Lab test within 15 days meet following criteria

  • Hemoglobin higher than 9.0g/dL
  • Leukocyte higher than 12,000/mm3
  • Neutrophil higher than 2,000/mm3
  • PLT higher than 10.0 104/mm3
  • Bilirubin lower than 1.5 times of upper limit of normal range
  • AST,ALT,ALP lower than 2.5 times of upper limit of normal range
  • Creatinine lower than upper limit of normal range

When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range

• ECOG 0 or 1
• Expected survival time more than 90 days

Exclusion Criteria:

• The patient who meet the following criteria should be excluded from this trial
• Patients who have severe drug allergic history(including: platinum related drugs,5-FU,FT,LV,5-HT3 receptor antagonist)
• Attended other clinical trial within 4 weeks
• Received transfusion of blood,related products or G-CSF within 15 days
• Received surgery within 4 weeks and the effect hadn't vanished
• Have diarrhea
• Have complication of active infection(infection caused fever higher than 38℃)
• Have complication of poor controlled hypercalcemia,hypertension,diabetes
• Have complication of severe ECG abnormal or other heart disease which will affect clinical treatment(including: cardiac dysfunction,myocardial infarction,angina)
• Have complication of severe pulmonary disease(including:interstitial pneumonia,pulmonary fibrosis,severe emphysema)
• Have complication of psychiatric disorder which will affect clinical treatment or have history of CNS disease
• Have complication of active gastrointestinal bleeding
• Have pleural effusion,ascites or pericardial effusion that need drainage
• Have complication of multiple bone metastasis
• Have severe complication(including:ileus,renal insufficiency,hepatic insufficiency,cerebrovascular disturbance)
• Have brain metastasis or suspicious brain metastasis
• Have active multiple primary cancer
• Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
• Investigator judge not eligible to this trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOL; single arm	Drug: S-1, leucovorin, oxaliplatin; S-1(20mg、25mg), capsule, 40~60mg, Bid,p.o., day1~7； LV (25 mg), tablet, 25mg,Bid,p.o., day1~7； L-OHP (50 mg),injection 85mg/m2, day1. repeated at every 2 weeks cycle till disease progression.; Other Names: S-1(20mg、25mg)--Taiho Pharmaceutical Co., Ltd.；; LV (25 mg)；; L-OHP (50 mg)--Sanofi Aventis Co., Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	from first administration till 28 days after last dosage

Secondary Outcome Measures

Outcome Measure	Time Frame
Tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, and follow up till disease progression or withdrawal from study due to intolerable adverse events (AE)	every 6 weeks

Collaborators and Investigators

• Sponsor: Shen Lin
• Collaborators: 307 Hospital of PLA; Tianjin Medical University Cancer Institute and Hospital; Beijing Union Hosptial; Hebei Provincial Cancer Hospital

Publications and helpful links

General Publications

• Lu M, Wang Y, Liu W, Bai C, Xu J, Shen L. A Multicenter Feasibility Study with S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients with Untreated Metastatic Colorectal Cancer: The Result of Final Analysis. Hepatogastroenterology. 2014 Jun;61(132):1018-23.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 26, 2010
• First Posted (Estimate): April 27, 2010

Study Record Updates

• Last Update Posted (Estimate): May 19, 2015
• Last Update Submitted That Met QC Criteria: May 17, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: colorectal cancer; oxaliplatin; S-1; leucovorin; SOL; unresectable or recurrent colorectal cancer
• 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; Antineoplastic Agents; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Oxaliplatin; Leucovorin
• Other Study ID Numbers: SOL feasibility study