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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
307 Hospital of PLA
Beijing Union Hosptial
Tianjin Medical University Cancer Institute and Hospital
Hebei Provincial Cancer Hospital
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01110941
First received: April 21, 2010
Last updated: June 7, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: S-1, leucovorin, oxaliplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: from first administration till 28 days after last dosage ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2009
Estimated Study Completion Date: October 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
  • Endpoints:
  • Primary endpoints: adverse drug reaction
  • Secondary endpoints:

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110941

Contacts
Contact: Lin Shen, M.D. 0086-10-88196561 lin100@medmail.com.cn
Contact: Eve You, M.D. 0086-10-59714220 lf-you@taihochina.com

Locations
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100036
Contact: Lin Shen, M.D.    0086-10-88196561    lin100@medmail.com.cn   
Sponsors and Collaborators
Peking University
307 Hospital of PLA
Beijing Union Hosptial
Tianjin Medical University Cancer Institute and Hospital
Hebei Provincial Cancer Hospital
  More Information

No publications provided

Responsible Party: Dr. Shen Lin/ Professor, Director of Digestive Oncology Department, Beijing Cancer Hospital, China
ClinicalTrials.gov Identifier: NCT01110941     History of Changes
Other Study ID Numbers: SOL feasibility study
Study First Received: April 21, 2010
Last Updated: June 7, 2010
Health Authority: China: Food and Drug Administration
China: Ministry of Health

Keywords provided by 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
Leucovorin
Levoleucovorin
Oxaliplatin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 10, 2014