Safety of Orectalip® (Oxaliplatin) as Adjuvant Treatment for High-risk Stage-Ⅱ Colorectal Cancer

NCT02284529 | Completed Phase 4

• 1 other identifier: SF12099
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Open- Label, Single Arm Study. To evaluate the safety profile of Orectalip® (oxaliplatin), fluorouracil and leucovorin as adjuvant therapy in the treatment of high-risk stage-Ⅱ colorectal cancer. Primary end point:To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study. Other end points:The incidence of Grade 3 or 4 neutropenia, thrombocytopenia, anemia, nausea, diarrhea vomiting over the 12 weeks. Safety will be evaluated including vital signs are recorded at all visits.

Conditions

Stage-Ⅱ Colorectal Cancer

Keywords

high-risk stage-Ⅱ Colorectal Cancer,Orectalip,oxaliplatin

Outcome Measures

Primary Outcomes (1)

• To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study

  Oxaliplatin 85mg/m2 in D5W 250 ml IV drip 2hrs on D1, Leucovorin 100mg/m2 in N/S 100ml IV drip 2hrs on D1, follow by 5-FU 2400mg/m2 IV infusion 24hrs on D1(cycle/ 2 weeks)To execute 12 cycles

  6month

Study Arms (1)

Orectalip® (Oxaliplatin)

EXPERIMENTAL

High-risk Stage-Ⅱ Colorectal Cancer treatment with Oxaliplatin 85mg/m2 in D5W 250 ml IV drip 2hrs on D1, Leucovorin 100mg/m2 in N/S 100ml IV drip 2hrs on D1, follow by 5-FU 2400mg/m2 IV infusion 24hrs on D1 to execute 8\~12 cycles

Drug: Orectalip

Interventions

Orectalip DRUG

Oxaliplatin 85mg/m2 in D5W 250 ml IV drip 2hrs on D1, Leucovorin 100mg/m2 in N/S 100ml IV drip 2hrs on D1, follow by 5-FU 2400mg/m2 IV infusion 24hrs on D1

Also known as: Fluorouracil, Leucovorin

Orectalip® (Oxaliplatin)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must have World Health Organization performance status score less than 1.
• Subject must have WBC more than 4,000 cells, platelet count more than 100,000, absolute neutrophil count more than 1,500 serum bilirubin level less than1.5mg, serum creatinine level less than1.5mg

You may not qualify if:

• Subject who has received oxaliplatin treatment
• Subject who has history of allergy to platinum derivates agents
• Subject who has decompensated liver function(ALT、 AST and alkaline phosphatase more than 2.5 times of upper limit of normal range).
• Subject has serious concomitant illness preceding the entry into the study.
• Female subject who is pregnant or breast feeding.
• Female subject who is going to be pregnant within 6 months during treatment.

Sponsors & Collaborators

• Sinphar Pharmaceutical Co., Ltd: lead
• Taichung Veterans General Hospital: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

Location

MeSH Terms

Interventions

Fluorouracil; Leucovorin

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Hwei-Ming Wang, Chief

  vghtc.crs@gmail.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Taichung Veterans General Hospital

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: November 6, 2014
• Study Start: October 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 6, 2014

Record last verified: 2014-10

Locations

TW (1)