Clinical trial NCT01305980: Evaluating the Safety and Efficacy of SB Injection in Patients With Advanced or Metastatic Colorectal Cancer
Official title: Phase Ⅱ,Open Label Clinical Trial to Investigate Safety and Efficacy of SB Injection in Patients With Advanced and Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: SBPharmaceutical IND, Co., LTD
Sponsor class: INDUSTRY
First posted: 2011-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine efficacy of SB injection in Colorectal Cancer.

Detailed description: All eligible patients will receive SB injection therapy for 6 cycles (14\~21 days for each cycle). Efficacy will be evaluated every 3 cycles.

Eligibility criteria: Inclusion Criteria:

* Age of 18years or over
* Patients who had failed more than 1 cycle of standard therapy with advanced or metastatic stage and with measurable lesions
* Life expectancy \>/= 5 months
* Not available to any of resectable surgery or radiotherapy
* Patients with adequate organ(e.g. heart, kidney, liver)and bone marrow function, as defined by

  1. Absolute neutrophil count \>/= 1.0 x 10\^9/L, Platelet count \>/= 75 x 10\^9/L
  2. Total bilirubin \< 2.0 mg/dL
  3. Aspartate Aminotransferase and/or Aspartate Aminotransferase \< 5 x Upper Limit Normal
  4. creatinine \< 2 x Upper Limit Normal
* ECOG status 0 to 2
* Female volunteers admitted to the study must be using a reliable means of contraception and must have a negative blood or urine pregnancy test at least 7days ago
* Patients or their legal representatives who have signed the informed consent form.

Exclusion Criteria:

* Have inflammatory bowel diseases
* Have severe diarrhea or ileus
* Previous total colectomy
* Have ileostomy
* Known brain or spinal cord metastases
* Patients who have received chemotherapy within the previous 4 weeks
* Patients who have received radiotherapy related tp colorectal cancer within 4weeks
* Patients who have participated in other clinical study within the previous 4weeks
* Pregnancy or lactation period
* Human Immunodeficiency Virus antibody (+)
* Have active infection or serious concomitant systemic disorder incompatible with the study
* Clinically hypertension or diabetes mellitus not well controlled with medication
* Clinically significant cardiac disease(congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction
* Presence or history of malignancy other than colorectal cancer within 5years
* Have severe Neurologic or psychological disorder
* Patients who have history of allergy with this investigational drug(SB injection)
* Obvious cognitive or physical impairment that would prevent participation

Primary outcomes:
measure: Evaluating Tumor Response Rate
timeFrame: 4 months
Secondary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: 4 months
measure: evaluate patient's performance by measuring Eastern Cooperative Oncology Group scale
timeFrame: 4 months
measure: Determine duration of response rate by measuring time to progression
timeFrame: 4 months
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Jung-gu
Study officials:
affiliation: Inha University Hospital
name: Yong-oon Shin, Prof
role: PRINCIPAL_INVESTIGATOR
References: