Prospective randomized multi-center open label phase II study to determine the antitumoral activity and the feasibility of a combination therapy with Hycamtin/Carboplatin administered 5-days versus 3-days versus Topotecan monotherapy 5-days as second line treatment for patients with histological or cytological verified relapse or progression of extensive disease small cell lung cancer, documented later than 60 days after day 1 of the last cycle of first-line therapy. MedDRA version: 9.1 Level:
Conditions
Interventions
Trade Name: Hycamtin
Product Code: SK&F104864A
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Topotecan hydrochloride
CAS Number: 119413-54-6
Current Sponso
Sponsors
Aktion Bronchialkarzinom e.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Pre-treated histologically confirmed small cell lung cancer (cytological diagnoses is permitted only in definitely and doubtless cases) • Relapse or progression of small cell lung cancer at least 60 days after day 1 of the last cycle of first-line therapy. • ECOG Performance Status 3.500 µl - Neutrophiles: >1.500 µl - Platelets: >100.000 µl - Hemoglobin >9 g/dl (to reach a Hb of 9 g/dl it is permittet to perform a transfusion of pRBCs or to apply Erythropoietin (EPO) • Adequate hepatic laboratory parameters: - Bilirubin : 60 ml/min • Provision of informed consent according to local regulatory requirements prior to any protocol specific treatment • Measurable lesion according to RECIST-Criteria • Negative pregnancy test for women of childbearing potential unless they are postmenopausal at baseline. (Postmenopausal women must have been amenorrheic at least for 12 months to be considered of non childbearing potential) • Women of child bearing potential must be willing to use an acceptable method to avoid pregnancy at least one month before study start. Examples: oral contraceptives (sole application of oral contraceptives is not sufficient), diaphragm pessary, intrauterine device (spiral), condom plus diaphragm pessary plus spermicide. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients without a previous chemotherapy • More than one previous chemotherapy • Patients with a previous radiotherapy (>25% Irradiation of bone marrow) within 6 weeks prior to study start • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of non-melanomatous skin cancer or cervical carcinoma of the cervix after curative therapy. • Pregnancy or lactation period or lack of effective contraception • Active infections prior to study start • Respiratory insufficiency • Cardiac insufficiency and NYHA III und IV • Known active Hepatitis B or Hepatitis C or HIV-Infection • Known hypersensitivity to any of the study drugs • Life expectancy less than 2 month • Patients with symptoms of CNS metastases or leptomeningeal metastasis receiving more than 12 mg/day dexamethasone • History of a mental disease or condition such as to interfere with the patient's ability to understand the requirements of the study protocol • Patients with any clinically significant disease that is in the opinion of the investigator likely to put the patient at risk or to interfere with the evaluation of the patient's safety and of the study outcome. • Concurrent participation in an other clinical trial • Participation in another clinical trial within the last 4 weeks • Male trial subjects not willing to use an acceptable method to avoid pregnancy of his wife/partner • Alcohol an drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this clinical trial is to determine the antitumoral activity and the feasibility of a combination therapy with Hycamtin/Carboplatin administered 5-days versus 3-days versus Topotecan monotherapy 5-days as second line treatment for patients with histological or cytological verified relapse or progression of extensive disease small cell lung cancer. Primary endpoint is the disease control rate (DCR). The DCR consists of all patients with complete response, partial response and stable disease.;Secondary Objective: • Overall survival • Quality of life • Remission rate • Time to progression • Tolerance to study drugs;Primary end point(s): The aim of this clinical trial is to determine the antitumoral activity and the feasibility of a combination therapy with Hycamtin/Carboplatin administered 5-days versus 3-days versus Topotecan monotherapy 5-days as second line treatment for patients with histological or cytological verified relapse or progression of extensive disease small cell lung cancer. Primary endpoint is the disease control rate (DCR). The DCR consists of all patients with complete response, partial response and stable disease. | — |
Countries
Germany
Outcome results
None listed