Study of Camtobell Inj (Belotecan) on Weekly Schedule in Non-small Cell Lung Cancer (NSCLC) Patients Previously Treated With Chemotherapy

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical
• Collaborators: Asan Medical Center; Samsung Medical Center; Seoul National University Hospital; Ulsan University Hospital
• Treatments: Belotecan; Camptothecin

Criteria

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