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

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ClinicalTrials.gov Identifier: NCT02284529
Recruitment Status : Completed
First Posted : November 6, 2014
Last Update Posted : November 6, 2014
Sponsor:
Collaborator:
Taichung Veterans General Hospital
Information provided by (Responsible Party):
Douglas Shr-Wei Chen, Sinphar Pharmaceutical Co., Ltd

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.


Condition or disease Intervention/treatment Phase
Stage-Ⅱ Colorectal Cancer Drug: Orectalip Phase 4

Detailed Description:

There were 18 out of 20 patients who completed the trial and eligible for statistical analysis, 2 patients withdraw because the wound infection. There were 11 (61%) male patients and 7 (39%) female patients. The patients aged from 30 to 73 years and their mean age was 50.4 years.

The grade of each adverse event evaluation mainly allocated in Grade 0 and Grade 1. The incidence of Grade 3 or 4 was only found for the following symptoms: leucopenia, neutropenia, and anemia. One (6%) adverse event of leucopenia occurred at visit 1 and visit 2, respectively. One (6%) adverse event of neutropenia occurs at visit 1, visit 2, and visit 3, respectively; while 2 (13%) events occurred at visit 5. One patients suffered adverse event of anemia at visit 5 and visit 6.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluate the Safety of Combination of Orectalip® (Oxaliplatin), Fluorouracil and Leucovorin as Adjuvant Treatment for High-risk Stage-Ⅱ Colorectal Cancer
Study Start Date : October 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Orectalip® (Oxaliplatin)
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
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
Other Names:
  • Fluorouracil
  • Leucovorin




Primary Outcome Measures :
  1. To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study [ Time Frame: 6month ]
    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



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Subject must have World Health Organization performance status score less than 1.
  2. 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

Exclusion Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284529


Locations
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Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Sponsors and Collaborators
Sinphar Pharmaceutical Co., Ltd
Taichung Veterans General Hospital
Investigators
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Principal Investigator: Hwei-Ming Wang, Chief vghtc.crs@gmail.com

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Responsible Party: Douglas Shr-Wei Chen, Taichung Veterans General Hospital, Sinphar Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02284529     History of Changes
Other Study ID Numbers: SF12099
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: October 2014
Keywords provided by Douglas Shr-Wei Chen, Sinphar Pharmaceutical Co., Ltd:
high-risk stage-Ⅱ Colorectal Cancer,Orectalip,oxaliplatin
Additional relevant MeSH terms:
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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
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs