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

NCT01110941 | Completed Phase 1

• 1 other identifier: SOL feasibility study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  from first administration till 28 days after last dosage

Secondary Outcomes (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)

  every 6 weeks

Study Arms (1)

SOL

EXPERIMENTAL

single arm

Drug: S-1, leucovorin, oxaliplatin

Interventions

S-1, leucovorin, oxaliplatin DRUG

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.

Also known as: S-1(20mg、25mg)--Taiho Pharmaceutical Co., Ltd.；, LV (25 mg)；, L-OHP (50 mg)--Sanofi Aventis Co., Ltd.

SOL

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shen Lin: lead
• 307 Hospital of PLA: collaborator
• Beijing Union Hosptial: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Hebei Provincial Cancer Hospital: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100036, China

Location

Related Publications (1)

• 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.

  PMID: 26158159 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

S 1 (combination); Leucovorin; Oxaliplatin; Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: pro

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 27, 2010
• Study Start: September 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

CN (1)