A phase II open-label, multi-centre, randomised, prospective, parallel-group study comparing Topotecan/Carboplatin administered 5 days versus 3 days versus Topotecan monotherapy daily x 5 as second line treatment for patients with relapsed extensive disease small cell lung cancer - Top Challenge

Conditions: 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: 9.1Level: LLTClassification code 10041068Term: Small cell lung cancer extensive stage

Registration Number: EUCTR2007-001069-14-DE

Lead Sponsor: Aktion Bronchialkarzinom e.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 < 2

•Life expectancy not less than 2 month

•No contraindication against any study medication used in this study

•No more than one previous chemotherapy with a minimum of 4 and a maximum of
6 cycles. The previous chemotherapy had to be platin-based.

•Age = 18 years

•Extensive disease at the time of relapse with indication to systemic
chemotherapy

•Adequate haematological parameters:

- Leukocytes: >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 : <1,5 x ULN
- Alk. Phosphatase: <3,0 x ULN

•Adequate renal laboratory parameters:

- Creatinin-Clearance > 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

•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