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

Chong Kun Dang

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Belotecan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01022671

11NSCLC08K

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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