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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Drug: S-1, leucovorin, oxaliplatin	Phase 1; Phase 2

Detailed Description:

• Endpoints:
• Primary endpoints: adverse drug reaction

• Secondary endpoints:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Multicenter Feasibility Study With S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients With Untreated Metastatic Colorectal Cancer
Study Start Date :	September 2009
Actual Primary Completion Date :	March 2010
Actual Study Completion Date :	October 2010

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: from first administration till 28 days after last dosage ]

Secondary Outcome Measures :

1. 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) [ Time Frame: every 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Shen Lin

307 Hospital of PLA

Beijing Union Hosptial

Tianjin Medical University Cancer Institute and Hospital

Hebei Provincial Cancer Hospital

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Shen Lin, pro, Peking University
ClinicalTrials.gov Identifier:	NCT01110941 History of Changes
Other Study ID Numbers:	SOL feasibility study
First Posted:	April 27, 2010
Last Update Posted:	May 19, 2015
Last Verified:	May 2015

Keywords provided by Shen Lin, Peking University:

S-1; leucovorin; oxaliplatin	colorectal cancer; SOL; unresectable or recurrent colorectal cancer

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; Oxaliplatin; Antineoplastic Agents