Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy
- Registration Number
- NCT01022671
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
A phase II study is conducted to determine the efficacy and safety of a single agent Camtobell inj.(belotecan) on a weekly schedule in locally advanced or metastatic non-small cell lung cancer patients previously treated with chemotherapy. The usefulness of the this regimen is evaluated by response rate, median survival time, progression free survival and duration of response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
-
19 Years and older
-
Histologically or cytologically confirmed locally advanced or metastatic NSCLC(Stage IIIB or IV)
-
≥ one measureable or evaluable lesion, <25% of the bone marrow had been irradiated
-
prior platinum based chemotherapy
-
ECOG PS ≤ 2
-
Life expectancy > 3 months
-
Adequate organ function:
- hematology: ANC ≥ 1.5×109/L, Platelet ≥ 100×109/L, hemoglobin ≥ 9.0g/dL
- hepatic: total bilirubin ≤ 1.5×ULN, AST/ALT ≤ 2.0×ULN, ALP ≤2.0×ULN
- renal: serum creatinine ≤ 1.5×ULN
-
Signed a written informed consent
Exclusion Criteria
- Active infection
- Symptomatic brain lesion
- Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix
- Severe concurrent diseases
- Prior anticancer therapy within 4 weeks before enroll
- Active pregnancy test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Belotecan Belotecan Single arm
- Primary Outcome Measures
Name Time Method Objective Response Rate every 2 cyc
- Secondary Outcome Measures
Name Time Method Adverse event every visit Overall Survival 6 months after Last patient out Progression Free survival 6 months after Last patient out